Post-Authorisation Safety Studies - EU edition MasterClass

20-22 February, 2023

Interventional studies fall into the scope of Directive 2001/20/EC and will no be the object of this Masterclass.

Post-Authorisation Safety Studies - EU edition MasterClass

Non-interventional studies are defined by the methodological approach used and not by its scientific objectives.

 

20-22 February, 2023, Virtual

Time Zone: UTC/GMT+1 /CET

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Pharma Online Masterclass

Overview

 

Legal requirements which are mandatory to non-interventional PASS conducted pursuant to an obligation imposed by an EU competent authority are recommended for non- interventional PASS conducted voluntarily in order to support the same level of transparency, scientific standards and quality standards. This applies, for example, to the format and content of the study protocol and of the final study report and its abstract.

 

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who should attend imgRECOMMENDATION

Who should attend?


• Pharmacovigilance professionals,including specialists in Risk Management and Risk Minimisation

• Auditors and PV Auditors

• Clinical Operations Professionals

• Regulatory Affairs Professionals

• Medical Affairs staff

• Project Management Professionals

Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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Years of experience

299

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3,410

Speakers

17,761

Attendees

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany