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All results for portal tecnológico · 2315 results

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
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
PULSATE Adopters Open Call | Webinar #1

PULSATE Adopters Open Call | Webinar #1

03 February, 2022 - 03 February, 2022

GoToWebinar

Webinar Alert for Laser Technology Adopters & End-Users!  Are you interested in adopting laser technology into your business? You can check if your idea is feasible with the PULSATE Adopters Programme! Join our 1st webinar: All you need to know about the Open Call for Laser Adopters for more details  Thursday, 3rd of February 2022, at 3 PM CET, Register Here  https://bit.ly/3GhxoeF What the webinar will cover? Introduct...

  • +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
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
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
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
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
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
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
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
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
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
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
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