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All results for portal tecnológico · 2370 results

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...

  • +1 month
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�...

  • +1 month
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...

  • +1 month
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     ...

  • +2 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...

  • +2 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...

  • +2 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...

  • +2 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...

  • +2 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...

  • +2 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 ...

  • +2 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      #...

  • +3 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...

  • +3 weeks
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...

  • +1 week
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...

  • +3 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 ...

  • +3 months