11th Edition R&D Controlling And Performance Management Conference

GLC Europe

Marketing Manager at GLC Europe

Sri LankaJoined March 2021

Summary

Research areas of interest (12)

  • Electronics, IT and Telecomms
  • Industrial manufacturing, Material and Transport Technologies
  • Industrial Technologies
  • Energy Technology
  • Physical Sciences and Exact Sciences
    • and 7 more

GLC Europe didn't publish any Technology Call yet

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Pharma Contract Drafting MasterClass

Pharma Contract Drafting MasterClass

30 - 31 August, 2021

Váci Road, Hungary

The Contract and legal document drafting seminar is an intensive training event for lawyers, and paralegals,working in the the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research agreements, joint-venture agreements, IP rights and key issues in commercial manufacturing...

  • +2 months
Advanced Precision Medicine MasterClass

Advanced Precision Medicine MasterClass

07 - 08 September, 2021

Váci Road, Hungary

Healthcare landscape is changing drastically due to the emergence of new technologies. Treatment is diverging from the general applications paradigm we were subjected in the past to a personalization for each patient and each disease type. This course will present a general overview on precision medicine with several case studies of the newest approaches in different medical areas. Additionally, it will include some important aspects of digital h...

  • +2 months
Manage the Annual Salary Review MasterClass

Manage the Annual Salary Review MasterClass

06 - 07 September, 2021

Váci Road, Hungary

Every compensation & benefits manager must know how to manage the annual salary review, and less experienced C&B specialists also must be able to support it. This course equips C&B professionals to competently perform their most important annual project, the annual salary review. The course covers pay for performance theories, salary budgeting, use of market data for midpoint updates, merit matrix development, developing a manager worksheet, rol...

  • +2 months
Pharma Mergers and Acquisitions MasterClass

Pharma Mergers and Acquisitions MasterClass

02 - 03 September, 2021

Váci Road, Hungary

This 2 day programme is intensive, and aimed at participants who wish to understand the various legal aspects of M&A in its different facets, it addresses the deal process, key documents including the Share Purchase Agreement, Disclosure Letter, specific issues Due Diligence in Life Sciences including IP, IT and Regulatory Warranties in Life Sciences with the distinctions between a share purchase and an asset purchase Sample documents will be sha...

  • +2 months
Pharmacovigilance on the Internet and Social Media MasterClass

Pharmacovigilance on the Internet and Social Media MasterClass

14 - 16 September, 2021

Váci Road, Hungary

The direct interaction between patients / users of pharmaceutical products and the Pharmaceutical Companies has had a big increase since the widespread use of the Internet and social media. In parallel, the requirements of the competent authorities towards the exhaustive collection and management of any adverse events related to the products marketed by the Marketing Authorisation Holders (MAH) are becoming more and more tight in order to better ...

  • +2 months
Fraud Prevention, Detection and Investigation MasterClass

Fraud Prevention, Detection and Investigation MasterClass

08 - 09 September, 2021

Váci Road, Hungary

How would you know if fraud was occurring in your organisation? Does your organisation have a fraud prevention strategy? Do you have a formal programme to tackle the risk posed by fraud? Do you have the use of any automated fraud detection techniques? If fraud is suspected do you have a clearly defined approach for managing the investigation? This course will help you significantly enhance your approach in all these key areas. CPE Credits ...

  • +2 months
CAPA and Root Cause Analysis MasterClass

CAPA and Root Cause Analysis MasterClass

21 - 22 September, 2021

Váci Road, Hungary

In today’s highly regulated pharma, biotech, device and animal health industries, it is essential to use the most efficient processes and ensure compliance with an active corrective and preventive action (CAPA) and RCA system. This course will cover CAPA and RCA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and RCA planning and implementation in practice of improvements. ...

  • +2 months
How to submit variations in Europe MasterClass

How to submit variations in Europe MasterClass

16 September, 2021 - 16 September, 2021

Váci Road, Hungary

Variations are an essential part of pharmaceutical products lifecycle and a critical milestone for the management of post-approval changes. Regulation worldwide is not yet harmonised and this course will help you understand the specific legal framework of variations in Europe. Through practical examples and exercices, you will learn to define the best submission strategy, evaluate the documents to prepare and understand the challenges of impl...

  • +2 months
H&S Legal Compliance and Leadership MasterClass

H&S Legal Compliance and Leadership MasterClass

15 - 16 September, 2021

Váci Road, Hungary

Many companies and their directors / senior individuals may not be fully familiar with their Health and Safety duties and the way in which changes to Health & Safety legislation (both in the UK and abroad)might impact them. This highly engaging and interactive seminar will highlight the key health and safety risks for companies and its individuals – and discuss how to limit liability and exposure to the risk of prosecution. You will also ge...

  • +2 months
Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

23 - 24 September, 2021

Váci Road, Hungary

The introduction of the Quality by Design concept in the early 2000’s has changed the paradigm of product and process development for recombinant biotherapeutics, switching from the process makes the product to the product makes the process. The Quality by Design approach starts by the understanding of the impact of changes in quality attributes on product clinical efficacy and safety. Without understanding it, it is difficult to develop a ma...

  • +2 months
Building Digital Health Solutions MasterClass

Building Digital Health Solutions MasterClass

23 - 24 September, 2021

Váci Road, Hungary

Digital health has grown exponentially as governments and other payers grapple with how to provide the best possible health outcomes at affordable costs. We believe that every healthcare decision should be informed by the best scientific research derived from rigorous, proven methodologies. In today’s world, healthcare decision makers across the globe are often faced with the need to select therapeutic “interventions” from multiple treat...

  • +2 months
Unlocking the Potential of Cell & Gene Therapies MasterClass

Unlocking the Potential of Cell & Gene Therapies MasterClass

23 - 24 September, 2021

Váci Road, Hungary

Nowadays, for as much as 95% of the 7 000 to 10 000 rare diseases that exist, there are no approved therapies. Of the estimated 400 M people worldwide afflicted with a rare disease, 50% are children. Cell and gene therapies have emerged as a new treatment paradigm for many rare diseases. These novel medicines have the potential to provide long-term therapeutic benefits for patients, however their development is both risky and cost intensive. A...

  • +2 months
Effective Remote Internal Auditing MasterClass

Effective Remote Internal Auditing MasterClass

30 September, 2021 - 01 October, 2021

Váci Road, Hungary

The last year has seen even more internal auditors and review teams adapt to the realities of working remotely. We have had to conduct business-critical internal audit engagements and reviews while working away from our desks, distant from our clients and from our management. These engagements may have been part of the annual or periodic plan, but may still be so important that even in the current pandemic, you must successfully deliver them. ...

  • +1 month
Advanced Stability Testing of Pharmaceuticals MasterClass

Advanced Stability Testing of Pharmaceuticals MasterClass

26 - 29 October, 2021

Váci Road 19, Hungary

Request Your Agenda Here! Advanced Stability Testing of Pharmaceuticals Online MasterClass Public Training Course will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life....

  • +4 weeks
Design Effective Incentives MasterClass

Design Effective Incentives MasterClass

08 - 09 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! Design Effective Incentives Online MasterClass is designed to equip human resources professionals in developing and improving the use of variable pay to support annual business results. This MasterClass covers the basic concepts in terminology surrounding variable pay including pay mix, types of incentives, team versus individual, line of sight, eligibility, performance measures and metrics, target setting and in...

  • +2 weeks
Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

10 - 11 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! This Online MasterClass Provides How to assure that all safety information is captured and collected in the Safety Databases. This Online Training also Covers Adequate collection, processing and timely reporting of safety information by all parties involved in the commercialization of a pharmaceutical product....

  • +2 weeks
Advanced E-PIL and E-Leaflet MasterClass

Advanced E-PIL and E-Leaflet MasterClass

11 - 12 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! Electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets) is becoming increasingly important in providing patients and medical staff with product data. A number of Regulatory Authorities now permit and indeed encourage this delivery mechanism and others are soon to follow. Advanced e-PIL & E-Leaflet Online MasterClass will provide the attendee with the building blocks for the establishment an...

  • +1 week
The OECD Principles of Good Laboratory Practices (GLP) MasterClass

The OECD Principles of Good Laboratory Practices (GLP) MasterClass

16 - 18 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! The understanding, development, implementation, follow-up and improvement of the GLP Principles is fundamental for the application of non-clinical health and environmental safety studies. This Online MasterClass of this GLP training course will be focussed to Introduction to the OECD (Organisation for Economic Co-operation and Development) Principles of GLP and Management responsibilities....

  • +1 week
Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

17 - 18 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! This MasterClass Training Provides How to assure that all safety information is captured and collected in the Safety Databases. This Online Training also Covers Adequate collection, processing and timely reporting of safety information by all parties involved in the commercialization of a pharmaceutical product....

  • +7 days
Process Validation for Biotechnological Products MasterClass

Process Validation for Biotechnological Products MasterClass

18 - 19 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! Process Validation Online MasterClass aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production, would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product....

  • +6 days
Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

17 - 18 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! This MasterClass Training Provides How to assure that all safety information is captured and collected in the Safety Databases. This Online Training also Covers Adequate collection, processing and timely reporting of safety information by all parties involved in the commercialization of a pharmaceutical product....

  • +7 days
Advanced CMC MasterClass

Advanced CMC MasterClass

22 - 24 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! Advanced CMC Online MasterClass will present key points in CMC which are currently the focus of Health Authorities, and which are critical for a successful developement, registration, and lifecycle of pharmaceutical products. This MasterClass in Pharma also covers general requirements for small molecules and biologics. The participants will gain knowledge via lecture-type sessions, letting substantial time for Q&A...

  • +2 days
Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

23 - 24 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! The Online MasterClass on Critical Quality Attributes of Recombinant Proteins for Therapeutic use will address the understanding of quality attributes, the purpose of assessing their criticality and how to select critical quality attributes. The Master Class will be illustrated by a review of physico-chemical variants, process- and product-related impurities and their impact on the product efficacy and safety....

  • +1 day
Signal and Risk Management in Pharmacovigilance MasterClass

Signal and Risk Management in Pharmacovigilance MasterClass

25 - 26 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! The focus of this two days Signal & Risk Management in Pharmacovigilance online Masterclass training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide thepractical advice on RMP drafting and preparation. The second day participants will have the opportunity to get an insight on the current signal detection and ...

  • +6 months
Negotiation in Healthcare MasterClass

Negotiation in Healthcare MasterClass

25 - 26 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! A two day Negotiation in Healthcare Online MasterClass training focusing on the best principles and practices of Negotiation as they apply in Healthcare markets with a special focus on practical issues, including Business Development, licensing, manufacturing, testing regimes, and product recall. This course also shows how to blend and exercise complex skill sets while negotiating with a wide range of partners, cus...

  • +6 months
The EU Clinical Trial Regulation MasterClass

The EU Clinical Trial Regulation MasterClass

25 - 26 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! The EU Clinical Trail Regulation Online MasterClass will provide an essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. This MasterClass in Pharma will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, vendor...

  • +6 months
CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass

CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass

25 - 26 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! CMC Readiness Online MasterClass will delineate potential adaptations to the traditional approach to product development, product characterization, specification setting, process validation, stability setting, manufacturing and timepoint for full completion of certain quality data packages....

  • +6 months
Advanced Enterprise Risk Management MasterClass

Advanced Enterprise Risk Management MasterClass

29 - 30 November, 2021

Váci Road 19, Hungary

Request Your Agenda Here! Manage and then deal with the risks at an enterprise level. Most organisations have now realised that much more is needed and have developed an Enterprise Risk management (ERM) approach. Advanced ERM goes one step further. Risks are evaluated based on business materiality. New understandings of risk emerge, and efficient controls can be implemented to tackle what really matters to the business....

  • +6 months
Advanced CMC MasterClass

Advanced CMC MasterClass

01 - 02 December, 2021

Váci Road 19, Hungary

Request Your Agenda Here! Advanced CMC Online MasterClass will present key points in CMC which are currently the focus of Health Authorities, and which are critical for a successful developement, registration, and lifecycle of pharmaceutical products. This MasterClass in Pharma also covers general requirements for small molecules and biologics. The participants will gain knowledge via lecture-type sessions, letting substantial time for Q&A...

  • +6 months
The EU Clinical Trial Regulation MasterClass

The EU Clinical Trial Regulation MasterClass

16 - 17 December, 2021

Váci Road 19, Hungary

Request Your Agenda Here! The New EU Clinical Trial Regulation (536/2014) will Replace the European Clinical Trials Directive (2001/20/EC) in 2022. The EU Clinical Trial Regulation Online MasterClass will Provide an Essential Understanding to help with Compliance with the new Regulation and Associated Implementing acts and other texts for carrying out clinical trials in the EU. This Programme will Highlight the Most Important of these Ke...

  • +6 months
Vendor/CRO Management and Oversight MasterClass

Vendor/CRO Management and Oversight MasterClass

12 - 13 January, 2022

Váci Road 19, Hungary

Request Your Agenda Here! On this Online MasterClass you will learn how to prepare a request for proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for projects you need to outsource. You will also cover the techniques for successfully managing CROs/ vendors and the shared responsibilities required by the sponsor and the service provider....

  • +6 months
Process Validation for Biotechnological Products MasterClass

Process Validation for Biotechnological Products MasterClass

14 - 17 February, 2022

Online Event

Process Validation Pharma Online MasterClass aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production, would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product.   #masterclass     #glceurope ...

  • +6 months
Pharmacovigilance Audit and Inspections MasterClass

Pharmacovigilance Audit and Inspections MasterClass

22 - 24 February, 2022

Online Event

This online masterclass will explore the key aspects of the pharmacovigilance audits, from planning audit programmes, conducting audits to delivering audit findings through audit reports. The impact of the pharmacovigilance legislation and GVP will be addressed and guidance will be provided on auditing PV systems both at a global and at a local organisation levels, including outsourced activities.   #masterclass     #glceurope      #...

  • +6 months
Pharma Analysing and Drafting Commercial Contracts MasterClass

Pharma Analysing and Drafting Commercial Contracts MasterClass

22 - 25 February, 2022

Online Event

This online Masterclass is an intensive training event for lawyers, and paralegals, working in the for the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research agreements, joint-venture agreements, IP rights and key issues in commercial manufacturing agreements for medic...

  • +6 months
Alternate Approaches to Validating a Computer System MasterClass

Alternate Approaches to Validating a Computer System MasterClass

28 February, 2022 - 01 March, 2022

Online Event

As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices for validation of computer systems using newer technologies. This online masterclass will take a deep dive into the mechanics, documentation, and ...

  • +6 months
US Pharma Contract Drafting MasterClass

US Pharma Contract Drafting MasterClass

28 February, 2022 - 03 March, 2022

Online Event

This online Masterclass is an intensive training event for lawyers, and paralegals, working in the for the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research agreements, joint-venture agreements, IP rights and key issues in commercial manufacturing agreements for medic...

  • +6 months
Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

07 - 08 March, 2022

Online Event

The Online MasterClass on Critical Quality Attributes of Recombinant Proteins for Therapeutic use will address the understanding of quality attributes, the purpose of assessing their criticality and how to select critical quality attributes. The Master Class will be illustrated by a review of physico-chemical variants, process- and product-related impurities and their impact on the product efficacy and safety.   #masterclass     #glceurop...

  • +6 months
CRO Contracting and Oversight MasterClass

CRO Contracting and Oversight MasterClass

07 - 08 March, 2022

Online Event

The operations and project management of a study that is run through a CRO is quite different from running a study in-house, yet companies often provide little or no formal training when they transition from in-house to CRO-run project management. This Online Training will train you in CRO oversight, and teach you how to design and implement the systems your company needs in order to issue a good RFP (request for proposal), evaluated the bids, c...

  • +6 months
Regulatory and Technology Considerations for the Design of Medical Device Software MasterClass

Regulatory and Technology Considerations for the Design of Medical Device Software MasterClass

07 - 09 March, 2022

Online Event

Medical Device Manufacturers have in Recent Years expanded thier Products Portfolio with Digital Solutions and added Connectivity to their Previous Standalone Devices. This Online MasterClass Will Cover Medical Device Classification and Regulatory Requirements also Participants will understand Implication of lifecycle management on the Digital Products and Understand Data Privacy and Cybersecurity Requirements.   #masterclass     #glceuro...

  • +6 months
The New EU Clinical Trial Regulation MasterClass

The New EU Clinical Trial Regulation MasterClass

07 - 09 March, 2022

Online Event

This online masterclass will provide the attendees with an understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission. This online training will also cover recent updates on EU-GCP and GMP associated with the new EU Regulation.   #masterclass     #glceurope      #pha...

  • +6 months
Advanced CMC MasterClass

Advanced CMC MasterClass

09 - 10 March, 2022

Online Event

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This training will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC. This online training will covers general requirements for small molecules and biologics.   #masterclass     ...

  • +6 months
Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

23 - 24 March, 2022

Online Event

It is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. This Online Training provides How to assure that all safety information is captured and collected in the Safety Databases. This Online Training also Covers Adequate collection, processing and timely repor...

  • +6 months
Process Validation for Biotechnological Products MasterClass

Process Validation for Biotechnological Products MasterClass

23 - 24 March, 2022

Online Event

Process Validation for Biotechnological Products online training aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production, would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product.   #masterclass...

  • +6 months
Advanced Quality Risk Management MasterClass

Advanced Quality Risk Management MasterClass

06 - 07 April, 2022

Online Event

In this online training, you will gain insight into how quality risk management (QRM) can be integrated into a modern pharmaceutical quality management system, how the capability of a QRM system can be assessed to improve the right elements at the right time, and which tools are used to set up a quality risk management system. By explaining the essential contents, this seminar is rounded off with all the necessary points for the independent imple...

  • +6 months
Corporate Governance MasterClass

Corporate Governance MasterClass

20 - 21 April, 2022

Online Event

Corporate Governance is now one of the hottest topics in the business world. It is both a regulatory requirement and a business enabler.  The Board and the Audit Committee need comprehensive assurance about this strategic business process. This Corporate Governance online training will provide all the tools and techniques essential to assess the complex and wide ranging field of Corporate Governance. This masterclass programme will help you ens...

  • +6 months
EU Good Pharmacovigilance Practices MasterClass

EU Good Pharmacovigilance Practices MasterClass

20 - 22 April, 2022

Online Event

GVP is drawn up to facilitate the performance of pharmacovigilance activities within the EU and applies to marketing authorisation holders in the EU, the Agency and competent authorities in Member States. GVP is being developed within a governance structure set up by the Agency and national competent authorities specifically for the implementation of the new pharmacovigilance legislation. This online training will explore the reasons for the exi...

  • +6 months
Pediatric Drug Development MasterClass

Pediatric Drug Development MasterClass

25 - 27 April, 2022

Online Event

Since 1997 the US reward pediatric drug studies with patent extension; since 2007 the EU demands pediatric investigation plans (PIPs) for new drugs. Without PIP, the EU approval of new drugs is blocked. Participants in this Pediatric Drug Development online masterclass will learn which trials in minors make sense, and which ones are pointless and even harmful. This can save companies millions of US $. Furthermore, they can avoid potential US d...

  • +6 months
Clinical Trial Regulation MasterClass

Clinical Trial Regulation MasterClass

26 - 29 April, 2022

Online Event

The EU Regulation No 536/2014 on “clinical trials on medicinal products for human use” was issued in April 2014. It regulates the planning, performing and evaluating of clinical trials in the EU, which are fully compliant with good clinical practice. This new regulation implements now a single application and approval process. This Online training will provide the new EU Clinical Trial Regulation requirements. #masterclass     #glceur...

  • +6 months
Advanced Stability Testing of Pharmaceuticals MasterClass

Advanced Stability Testing of Pharmaceuticals MasterClass

26 - 29 April, 2022

Online Event

Advanced Stability Testing of Pharmaceuticals Online MasterClass Program will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life.   #masterclass     #glceurope      #pharma      #globaltraining       #stabilitytestingpharmaceutical...

  • +6 months
Immunogenicity MasterClass

Immunogenicity MasterClass

28 - 29 April, 2022

Online Event

A important topic for complex therapeutics like Biologics, Biopharmaceuticals, Biosimilars & ATMPs Wanted for different kind of vaccines, unwanted for a variety of complex Large Biological Entities (LBEs). This Immunogenicity online training will determine and discuss about a complex and safety related topic.   #masterclass     #pharmaonlinemasterclass      #glceurope      #globalleadingconferences       #immunogenicity...

  • +6 months
Advanced Stability Testing of Pharmaceuticals MasterClass

Advanced Stability Testing of Pharmaceuticals MasterClass

09 - 12 May, 2022

Online Event

Advanced Stability Testing of Pharmaceuticals Online Training Programme will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life.   #masterclass     #glceurope      #pharma      #globaltraining       #stabilitytestingpharmaceutical...

  • +6 months
Good Clinical Practice MasterClass

Good Clinical Practice MasterClass

10 - 11 May, 2022

Online Event

This Good Clinical Practice online masterclass provides an in-depth understanding of GCP requirements and their practical implications as well as insights into the current GCP inspection focus and hot topics....

  • +6 months
Advanced CMC MasterClass

Advanced CMC MasterClass

10 - 12 May, 2022

Online Event

 This course will present key points in CMC which are currently the focus of Health Authorities, and which are critical for a successful developement, registration, and lifecycle of pharmaceutical products + 1 Day training on How to submit variations in Europe....

  • +6 months
Auditing Major Projects MasterClass

Auditing Major Projects MasterClass

11 - 12 May, 2022

Online Event

The Online MasterClass Provide you knowledge to promote the benefits of an audit involvement in all key projects and apply the concepts and practical application of a risk based approach to project audit so you can audit major projects with confidence....

  • +6 months
Design Effective Incentives MasterClass

Design Effective Incentives MasterClass

12 - 13 May, 2022

Online Event

Design Effective Incentives MasterClass training is designed to equip human resources professionals in developing and improving the use of variable pay to support annual business results. This training in HR provides essential principles and common practices for designing effective corporate, sales or other types of incentives or bonus schemes, with many real examples....

  • +6 months
Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

17 - 18 May, 2022

Online Event

This MasterClass Training Provides How to assure that all safety information is captured and collected in the Safety Databases....

  • +6 months
International Negotiations in Pharma MasterClass

International Negotiations in Pharma MasterClass

18 - 19 May, 2022

Online Event

International Negotiation in Pharma Online Training shows how to blend and exercise complex skill sets while negotiating with a wide range of partners, customers and even hospitals, government departments and research institutes....

  • +6 months
Contamination Control Strategy MasterClass

Contamination Control Strategy MasterClass

19 - 20 May, 2022

Online Event

 This online course will present you what is meant by “Contamination Control Strategy”? It is a complex system of measures designed to minimize the risk of contamination in the manufacture of pharmaceuticals....

  • +6 months
Stability studies especially for Biologics & ATMPs MasterClass

Stability studies especially for Biologics & ATMPs MasterClass

19 - 20 May, 2022

Online Event

This online masterclass will present you the importance of stability studies for complex drugs, planning of sustainable stability studies and performance & evaluation of study results....

  • +6 months
Regulatory Affairs MasterClass

Regulatory Affairs MasterClass

23 - 25 May, 2022

Online Event

Regulatory Affairs online masterclass focus on the regulator landscape in Europe and will provide an insight on critical milestones from early development until post approval activities and Specific focus is given on biological CMC requirements....

  • +6 months
Signal and Risk Management in Pharmacovigilance US MasterClass

Signal and Risk Management in Pharmacovigilance US MasterClass

23 - 26 May, 2022

Online Event

The focus of this three days Signal & Risk Management in Pharma online MasterClass training will be providing an update of ongoing activities regarding medicines’ risk and signal management. This Training also provides the practical advice on RMP drafting and preparation....

  • +6 months
CRO Oversight MasterClass

CRO Oversight MasterClass

26 - 27 May, 2022

Online Event

This online training provides an overview of the key concepts and best practices for CRO management in a global clinical trial setting. It also includes information about the global regulatory landscape regarding CRO management, primarily focusing on EMA, FDA, and ICH E6(R2)....

  • +5 months
Viral Clearance MasterClass

Viral Clearance MasterClass

30 - 31 May, 2022

Online Event

This online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics, how to prevent those risks and how to evaluate the capability of the process to remove and/or inactivate potential viruses through viral clearance studies. ...

  • +5 months
Advanced CMC MasterClass

Advanced CMC MasterClass

13 - 14 June, 2022

Online Event

This Masterclass will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC, and also this training covers general requirements for small molecules and biologics....

  • +5 months
Process Validation for Biotechnological Products MasterClass

Process Validation for Biotechnological Products MasterClass

20 - 23 June, 2022

Online Event

The online training aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production....

  • +5 months
HSE360 Summit 2022

HSE360 Summit 2022

29 - 30 September, 2022

Online Event

HSE360 2022 will provide participants with a platform for information exchange and networking with experts from all across the world. The attendees will be presented with a number of sessions on today’s current issues and trends....

  • +1 month
Design Effective Incentives MasterClass | 29 & 30 August, 2022, Virtual

Design Effective Incentives MasterClass | 29 & 30 August, 2022, Virtual

29 - 30 August, 2022

Metro Manila, Philippines

Design Effective Incentives MasterClass training is designed to equip human resources professionals in developing and improving the use of variable pay to support annual business results. This training in HR provides essential principles and common practices for designing effective corporate, sales, or other types of incentives or bonus schemes, with many real examples. Distinguish and Select Incentive types based on Purpose Determine ...

  • +2 months
Deviation and Change Control Management in Pharma MasterClass | 01 & 02 September, 2022, Virtual

Deviation and Change Control Management in Pharma MasterClass | 01 & 02 September, 2022, Virtual

01 - 02 September, 2022

Metro Manila, Philippines

This online masterclass will give you a deep dive into the correct management and look into the individual steps for the management of a deviation, like the root cause analysis, the CAPAs, the success control and the risk assessment. Key Elements Regulatory Requirements Approach Management Process Detailed ChangeControl Process Examples Direct from Practice Quality Systems Linked to Deviations and CCs  ...

  • +2 months
Pharmacovigilance System Master File MasterClass

Pharmacovigilance System Master File MasterClass

05 - 06 September, 2022

Online Event

Pharmacovigilance System Master File MasterClass shall describe the pharmacovigilance system and support/document its compliance with the requirements. As well as fulfilling the requirements for a PSMF laid down in the legislation and guidance. Key Elements: Registration and Maintainance of the PSMF Contents and Information that should contain Format and Layout Change control and versions Archiving and Storage Responsabilities...

  • +2 months
Pediatric Drug Development MasterClass

Pediatric Drug Development MasterClass

05 - 07 September, 2022

Online Event

Participants in this Pediatric Drug Development online masterclass will learn which trials in minors make sense, and which ones are pointless and even harmful. They can avoid potential US damage lawsuits.  Key Elements: Venture into undiscovered territories and gain inspiration through collaboration Boost your professional skills by directly engaging with domain experts Gain value and learn from the best instructors Build a top-n...

  • +2 months
Advanced Stability Testing of Pharmaceuticals Asian MasterClass

Advanced Stability Testing of Pharmaceuticals Asian MasterClass

05 - 08 September, 2022

Online Event

Advanced Stability Testing of Pharmaceuticals MasterClass will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life. Key Elements: Venture into undiscovered territories and gain inspiration through collaboration Boost your professional skills by directly engaging with domain experts ...

  • +2 months
Patient Engagement in HTA Processes MasterClass

Patient Engagement in HTA Processes MasterClass

15 - 16 September, 2022

Online Event

The purpose of this Master Class is to sensitize participants for the value patient engagement and provide a brief introduction on the practicalities of patient engagement in HTA processes. 15 - 16 September, 2022, Virtual Time Zone: UTC/GMT+1 /CET Key Elements: Understand the current and potential future impact of including patients’ perspectives. Understand current state of patient engagement in HTA processes in vario...

  • +2 months
Pharmacovigilance Audit and Inspections US MasterClass

Pharmacovigilance Audit and Inspections US MasterClass

13 - 15 September, 2022

Online Event

The training will explore the key aspects of pharmacovigilance audits (PV Audits), from planning audit programmes, conducting audits to delivering audit findings through audit reports. The impact of the pv legislation and GVP will be addressed and guidance will be provided. Key Elements: Understand different types of audits. Assessment criteria for auditing. Key principles on audit design and preparation. ...

  • +2 months
Behavioral Good Manufacturing Practices MasterClass

Behavioral Good Manufacturing Practices MasterClass

19 - 20 September, 2022

Online Event

The main goals of this online masterlass are based around improvements in GMP compliance and error reduction. Key elements: Understand the need for cultural change when managing our GMP compliance. Measure the Cost of Compliance in our manufacturing operation. Overview of the bGMP cultural change programme. Understand the different models of human error, human thinking processes and actions. ...

  • +2 months
Clinical Project Management MasterClass

Clinical Project Management MasterClass

26 - 29 September, 2022

Online Event

During these 4 day online masterclass, Trainees will learn how to adapt their project management knowledge to clinical trials.  Key Elements: What are the fundamentals of Project Management? The Project Manager (negotiation, delegation, dealing with clients, quality)? The Project Environment (regulations, guidelines, SOPs) The clinical development Plan. The definition and initiation of a Trial (scope, feasibility, CDP) How...

  • +1 month
Viral Clearance MasterClass

Viral Clearance MasterClass

03 - 04 October, 2022

Online Event

This online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics, how to prevent those risks and how to evaluate the capability of the process to remove and/or inactivate potential viruses through viral clearance studies.  Key Elements: Understand the consequences linked to a contamination of mammalian cell cultures and biologicals Understand the regulatory expectations on prev...

  • +1 month
Advanced CMC MasterClass

Advanced CMC MasterClass

05 - 06 October, 2022

Online Event

This training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex.  Key Elements: Understand the different levels of requirements in CMC during the development and post-approval phase. Overview of stability requirements. Understand what are the Essential Requirements for a Drug Substance. ...

  • +1 month
Implementation of ISO 13485 MasterClass

Implementation of ISO 13485 MasterClass

10 - 11 October, 2022

Online Event

Implementation of ISO 13485 MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation it is important to decide if, when and how ISO13485 should be implemented within your organisation. Key Elements: Medical device quality system requirements and when they apply to medicinal products. Determining whether to implement ISO13485 in the ...

  • +1 month
Advanced Stability Testing of Pharmaceuticals MasterClass

Advanced Stability Testing of Pharmaceuticals MasterClass

10 - 13 October, 2022

Online Event

Advanced Stability Testing of Pharmaceuticals Online MasterClass ill cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life. Key Elements:. The Impact of Thermal Energy and Humidity on Degradation. The opportunities for reduced stability studies. The Smart Selection of...

  • +1 month
Pharma Packaging MasterClass

Pharma Packaging MasterClass

11 - 12 October, 2022

Online Event

This practical training Course's goal is to cover the technical and organisational requirements and procedures of pharma and healthcare packaging and technical operations in a 360-degree coverage. Key Elements: The Requirements of pharma and healthcare packaging. The Global Healthcare and Pharma Market. The concept of the ‘human imperative’ and its practical application. The technical implementatio...

  • +1 month
Quality control for ATMPs and Biologics MasterClass

Quality control for ATMPs and Biologics MasterClass

17 October, 2022 - 17 October, 2022

Online Event

You will learn about quality control requirements for Biologics and Advanced Therapy Medicinal Products (ATMPs). Key Elements: Specifications for Biologics and ATMPs Quality Control for Biologics and ATMPs Visit the official website for more information on the MasterClass: https://glceurope.com/events/pharma/quality-control-for-atmps-and-biologics-masterclass...

  • +1 month
Process Validation for Biotechnological Products Asian MasterClass

Process Validation for Biotechnological Products Asian MasterClass

18 - 21 October, 2022

Online Event

The online training aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production. 18 - 21 October, 2022, Virtual Time Zone: UTC+08:00 Process Validation Pharma Asian Online MasterClass aims to provide deeper understanding on how process validation for biotechnological processes, which is the colle...

  • +1 month
Cell Bank Establishment & Testing MasterClass

Cell Bank Establishment & Testing MasterClass

07 - 08 November, 2022

Online Event

The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH Q11) but it is also the starting point of the manufacturing process of therapeutical recombinant proteins and gene therapy products. 07 & 08 November, 2022, Virtual Time Zone: Eastern Standard Time (EST) / UTC−05:00 The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH Q11) but it is also the starting point ...

  • +2 weeks
Pharma/Biotech Mergers and Acquisition MasterClass US

Pharma/Biotech Mergers and Acquisition MasterClass US

15 - 18 November, 2022

Online Event

Pharmaceutical Industry mergers and acquisitions are complicated, time-consuming, and challenging. No matter how big or small, there will always be legal, financial, and regulatory implications to consider as well as quality and safety, and Intellectual property considerations that must be addressed. This online training event will address the particular issues which affect Pharmaceutical M&A work, equipping participants with a broader understan...

  • +1 week
Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

21 - 22 November, 2022

Online Event

With modern facilities, installations, and equipment, PLCs and computers are an integral part of such systems. More often than not PLCs and computers are considered autonomous systems and handled separately within the QMS and protocols. In this two-day course, we will look at Basic Principles of Computerized Systems Compliance using ISPE’s GAMP5 Version 2 industry guidelines, compared to FDA’s Title 21 CRF Part 11 regulations, and EU’s Eudr...

  • +3 days
Entry Level CMC - US edition MasterClass

Entry Level CMC - US edition MasterClass

21 - 22 November, 2022

Online Event

Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics....

  • +3 days
GAMP® 5 - US edition MasterClass

GAMP® 5 - US edition MasterClass

21 - 22 November, 2022

Online Event

In this Master Class, we will review the current trends, including in technology and in FDA compliance and enforcement. We’ll look at Data Integrity, 21 CFR Part 11 (Electronic Records/Electronic Signatures), European Union (EU) Annex 11, General Data Protection Regulation (GDPR), and other regulatory requirements....

  • +3 days
Cross-contamination Risk Assessment in Pharmaceutical Manufacturing - EU edition MasterClass

Cross-contamination Risk Assessment in Pharmaceutical Manufacturing - EU edition MasterClass

21 - 22 November, 2022

Online Event

It is common practice in the Pharmaceutical Industry to manufacture multiple drug products in shared facilities with shared equipment. To avoid cross-contamination, all surfaces with product contact are cleaned prior to manufacturing of the subsequent product. According to current EU GMP requirements, the cleaning process has to be validated taking into account the API specific PDE (“Permitted Daily Exposure”) values. The EMA “Guideline on ...

  • +3 days
Pharmaceutical Reference Standards - EU edition MasterClass

Pharmaceutical Reference Standards - EU edition MasterClass

22 - 23 November, 2022

Online Event

Reference standards are an essential tool in the quality control of APIs (active pharmaceutical ingredients), excipients and medicinal products. They may be obtained from official sources or may, under certain circumstances, be developed and maintained in-house. In this training course you will learn about the correct use of official (pharmacopoeial) standards and regulatory requirements but also about the possiblity to establish in-house standar...

  • +2 days
Process Validation for Biotechnological Products - EU edition MasterClass

Process Validation for Biotechnological Products - EU edition MasterClass

22 - 23 November, 2022

Online Event

Process Validation for Biotechnological Products MasterClass aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production....

  • +2 days
Contamination Control Strategy - EU edition MasterClass

Contamination Control Strategy - EU edition MasterClass

24 - 25 November, 2022

Online Event

 This online course will present you what is meant by “Contamination Control Strategy”? It is a complex system of measures designed to minimize the risk of contamination in the manufacture of pharmaceuticals....

  • +03 hours
Advanced Pharmaceutical Quality Control - EU edition MasterClass

Advanced Pharmaceutical Quality Control - EU edition MasterClass

28 - 29 November, 2022

Online Event

The coursewill provide an update on the current state of the art of analytical development, validation and life cycle management of analytical procedures...

  • +6 months
Method Validation and Transfer with focus on the new ICH Q2(R2) MasterClass

Method Validation and Transfer with focus on the new ICH Q2(R2) MasterClass

05 December, 2022 - 05 December, 2022

Online Event

The new draft ICH guideline for method validation ICHQ2(R2) has been published for comment. Together with the new ICHQ14 guideline for method development, both guidelines represent a fundamental change of direction in method development and validation, e.g. implementation of ATP (analytical target profile). The WHO guidelines on transfer of technology in pharmaceutical manufacturing as well as the new draft ICH guidelines represent the new basis ...

  • +6 months
Particle Size Characterization - EU edition MasterClass

Particle Size Characterization - EU edition MasterClass

05 - 08 December, 2022

Online Event

This course will explores various approaches to particle size and shape characterization requirements for active pharmaceutical ingredients (APIs) during oral solid dosage product development....

  • +6 months
ICH Q10: How to manage your Quality System including Quality KPIs - EU edition MasterClass

ICH Q10: How to manage your Quality System including Quality KPIs - EU edition MasterClass

12 - 13 December, 2022

Online Event

The ICH Q10 guideline - Pharmaceutical Quality System (PQS) - is one of the most important international regulations adopted by major regulatory bodies such as FDA, EMA, and others being cited in countless audit observations. The Master Class is completed by fundamentals of an appropriate Quality Culture which constitute the basis for a successful PQS....

  • +6 months
Cell Bank Establishment & Testing - US edition MasterClass

Cell Bank Establishment & Testing - US edition MasterClass

23 - 24 January, 2023

Online Event

The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH Q11) but it is also the starting point of the manufacturing process of therapeutical recombinant proteins and gene therapy products....

  • +6 months
Cell Bank Establishment & Testing - EU edition MasterClass

Cell Bank Establishment & Testing - EU edition MasterClass

30 - 31 January, 2023

Online Event

This online training will also address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks. ...

  • +6 months
Advanced CMC - EU edition MasterClass

Advanced CMC - EU edition MasterClass

31 January, 2023 - 02 February, 2023

Online Event

 This training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex. ...

  • +6 months
Clinical Project Management - US edition MasterClass

Clinical Project Management - US edition MasterClass

13 - 16 February, 2023

Online Event

During this online training, Trainees will learn how to adapt their project management knowledge to clinical trials. They will see how to manage clinical trials, setting milestones, doing risk management, allocating staff and budgets, dealing with clients and contracts. Several components of successful project management such as interaction between project activities and key decisions will be highlighted.  ...

  • +6 months
Method Validation and Transfer with focus on the new ICH Q2(R2) - US edition MasterClass

Method Validation and Transfer with focus on the new ICH Q2(R2) - US edition MasterClass

02 - 03 March, 2023

Online Event

Online Masterclass gives practical examples from method validation and method transfer & pitfalls. Also Participants can ask questions interactively....

  • +6 months
Pharma Packaging - US edition MasterClass

Pharma Packaging - US edition MasterClass

06 - 09 March, 2023

online

 This course will deal with Child Resistant packaging, with Smart packaging and will cover tamper evident packaging and the qualification of tamper verification features on healthcare packaging.  ...

  • +6 months
Signal and Risk Management in Pharmacovigilance - US edition MasterClass

Signal and Risk Management in Pharmacovigilance - US edition MasterClass

06 - 09 March, 2023

online

The focus of this four days Signal & Risk Management in Pharma online MasterClass training will be providing an update of ongoing activities regarding medicines’ risk and signal management. This Training also provides the practical advice on RMP drafting and preparation....

  • +6 months
Dissolution testing - EU edition MasterClass

Dissolution testing - EU edition MasterClass

07 - 08 March, 2023

online

This topic is not only of central importance in the context of generic drug development, but also in particular in the case of changes in the physicochemical properties of the active substance, in the manufacture and/or composition of products, and in the case of site transfers....

  • +6 months
Advanced CMC - EU edition MasterClass

Advanced CMC - EU edition MasterClass

08 - 10 March, 2023

online

 This training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex. ...

  • +6 months
CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products - US edition Masterclass

CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products - US edition Masterclass

13 - 14 March, 2023

online

CMC Readiness will delineate potential adaptations to the traditional approach to product development, product characterization, manufacturing and timepoint for full completion of certain quality data packages....

  • +6 months
Viral Clearance - US edition MasterClass

Viral Clearance - US edition MasterClass

16 - 17 March, 2023

online

This online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics, how to prevent those risks and how to evaluate the capability of the process to remove and/or inactivate potential viruses through viral clearance studies.   ...

  • +6 months
Pharmacovigilance on the Internet and Social Media - EU edition MasterClass

Pharmacovigilance on the Internet and Social Media - EU edition MasterClass

27 - 29 March, 2023

online

Interaction between pharmaceutical companies and patients/users through the Internet. Social media and two-way communication....

  • +6 months
Good API GMP manufacturing practices with focus on ICH Q7 - US edition MasterClass

Good API GMP manufacturing practices with focus on ICH Q7 - US edition MasterClass

20 - 22 March, 2023

online

GMP hot topics of the guideline will be explained using real life examples. Practical advise will be given on how to fulfil the requirements of ICH Q7...

  • +6 months
Process Validation for Biotechnological Products - Australian edition MasterClass

Process Validation for Biotechnological Products - Australian edition MasterClass

20 - 23 March, 2023

online

Process Validation for Biotechnological Products MasterClass aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production....

  • +6 months
Pediatric Drug Development - EU edition MasterClass

Pediatric Drug Development - EU edition MasterClass

27 - 29 March, 2023

Online Event

Participants in this Pediatric Drug Development online masterclass will learn which trials in minors make sense, and which ones are pointless and even harmful. They can avoid potential US damage lawsuits. ...

  • +6 months
Contamination Control Strategy - US edition MasterClass

Contamination Control Strategy - US edition MasterClass

20 - 21 April, 2023

Online Event

 This online course will present you what is meant by “Contamination Control Strategy”? It is a complex system of measures designed to minimize the risk of contamination in the manufacture of pharmaceuticals. Overview Contamination Control Strategy Online training will present you what is meant by “Contamination Control Strategy”? It is a complex system of measures designed to minimize the risk of contamination in the manufacture o...

  • +6 months
CRO Oversight - US edition MasterClass

CRO Oversight - US edition MasterClass

24 - 27 April, 2023

Online Event

This course will train you in CRO oversight, and teach you how to design and implement the systems your company needs in order to issue a good RFP (request for proposal), evaluated the bids, choose a partner CRO and then oversee your project to conclusion. Overview Most pharma, biotech and device companies outsource some or all of their clinical trials program to one or more CROs. The operations and project management of a study that is run...

  • +6 months
Patient Advocacy in Cell and Gene Therapies - EU edition MasterClass

Patient Advocacy in Cell and Gene Therapies - EU edition MasterClass

25 - 26 April, 2023

Online Event

In most cases patient access is not “black and white” but multifactorial with some aspects appearing superficially simple, but quickly becoming complicated with room for error...

  • +6 months
Cell Bank Establishment & Testing - US edition MasterClass

Cell Bank Establishment & Testing - US edition MasterClass

26 - 27 April, 2023

Online Event

The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH Q11) but it is also the starting point of the manufacturing process of therapeutical recombinant proteins and gene therapy products....

  • +6 months
Natural Capital and Biodiversity - EU edition MasterClass

Natural Capital and Biodiversity - EU edition MasterClass

02 - 03 May, 2023

Online Event

This Masterclass provides guidelines, frameworks and tools that will enable participants to build their own strategies to best manage their nature related risks and build resilience in their organisations....

  • +6 months
Pharmacovigilance Audit and Inspections - US edition MasterClass

Pharmacovigilance Audit and Inspections - US edition MasterClass

02 - 04 May, 2023

Online Event

The training will explore the key aspects of the pharmacovigilance audits (PV Audits), from planning audit programmes, conducting audits to delivering audit findings through audit reports. The impact of the pv legislation and GVP will be addressed and guidance will be provided....

  • +6 months
Entry Level CMC - EU edition MasterClass

Entry Level CMC - EU edition MasterClass

04 - 05 May, 2023

online

Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics....

  • +6 months
Development of generics: From R&D to GMP - US edition MasterClass

Development of generics: From R&D to GMP - US edition MasterClass

08 - 11 May, 2023

Online Event

The training aims to generate a common understanding of how to best interlink two areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products.....

  • +6 months
Fundamentals of Toxicology - US edition MasterClass

Fundamentals of Toxicology - US edition MasterClass

09 - 12 May, 2023

Online Event

This will allow non-toxicologists to learn the jargon and be able to effectively communicate with colleagues. In addition, the MasterClass will describe the basics of toxicology to allow non-specialists to understand the content of a toxicology report. ...

  • +6 months
Pharmacopoeial compliance testing - EU edition MasterClass

Pharmacopoeial compliance testing - EU edition MasterClass

10 - 11 May, 2023

Online Event

 In this context, particular attention is paid to the revised, harmonized chapter on chromatography and the new chapter on implementation of pharmacopoeial procedures and you will learn how to apply these important texts in workshops and question and answer sessions....

  • +6 months
HSE360 Summit 2023

HSE360 Summit 2023

09 - 11 October, 2023

Vienna, Austria

HSE360 will provide participants with a platform for information exchange and networking with experts from all across the world. The attendees will be presented with a number of sessions on today’s current issues and trends including behavioral safety and engagement, well-being and mental health activities, how to attract the next generation, use of modern technologies.     SPONSORS 1. Intelex Technologies - https://www.intelex.co...

  • +1 month

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