The EU Clinical Trial Regulation - Compliance - EU edition MasterClass

07 - 10 November, 2022

This MasterClass provides especially information for employees in pharmaceutical/biotech industry supervising the performing of Clinical Trials by CROs. Also employees “from outside Europe” get insights as how to run and supervise Clinical Trials in “Europe”.

The EU Clinical Trial Regulation - Compliance - EU edition MasterClass

This MasterClass provides especially information for employees in pharmaceutical/biotech industry supervising the performing of Clinical Trials by CROs. Also employees “from outside Europe” get insights as how to run and supervise Clinical Trials in “Europe”.

 

07 - 10 November, 2022, Virtual

Time Zone: UTC/GMT+1 /CET

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Overview

masterclass in pharma

Overview

 

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 (GCP, e.g. Declaration of Helsinki or ICH GCP). This new regulation implements now a single application and approval process, for Competent Authority/Health Authority Approval AND Ethical Approval (IEC/IRB) for all member states - One application now via the EMA in Amsterdam, instead of dozens of ethical applications and dozens of competent authorities applications in each single state, resulting in one single, concise approval instead of dozens sometimes conflicting approvals and votes.

#masterclass     #glceurope      #pharmaonlinemasterclass      #globalleadingconferences       #EUclinicaltrailregulation      #EUclinicaltrialcompliance

masterclass in pharmaRECOMMENDATION

Who should attend?


• Project Managers

• Study/Trial Managers

• Study Start-up Specialists

• Medical/Scientific Advisers

• Lead/Senior-CRAs

• in the pharmaceutical or biotech industry or CROs

• Participants from EU/EEA, Rest of Europe and Rest of World

• (Academic) Investigators/Site Staff, Study Coordinators planning and performing IITs (Investigator Initiated/Sponsored Trials)

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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10+

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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