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

29-30 May, 2024

The risk benefit ratio should be maintained at all times

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

The agreements between pharmaceutical companies marketing a certain product should include agreements (so called Safety Data Exchange Agreements, SDEAs) to ensure the adequate flow of any arising safety concerns.

 

29-30 May, 2024, Virtual
Time Zone: UTC/GMT+1 /CET

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Pharma Online Masterclass

Overview

 

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. It is crucial and tightly required by the Regulatory Authorities that the safety information arising at any point is adequately captured, distributed and adequately and timely reported. The risk benefit ratio should be maintained at all times and for this reason agreements between pharmaceutical companies marketing a certain product should include agreements (so called Safety Data Exchange Agreements, SDEAs) to ensure the adequate flow of any arising safety concerns.

This should also be considered in all outsourced activities of a pharmaceutical company that may lead to any capture of safety information related to the products of which the company is the Marketing Authorization Holder (MAH

 

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who should attend imgRECOMMENDATION

Who should attend?


• Pharmacovigilance professionals
• Auditors and PV Auditors
• Medical Affairs Professionals involved in outsourced Medical Activities as Advisory
Boards, Congresses, etc
• Marketing Professionals working in outsourcing activities
• Legal Department Professionals

Testimonial

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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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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