Webinar “Impact changes clinical trial regulation (& CTIS)”

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Do you understand the full impact of the changes in the EU Clinical Trial Regulation on your day-to-day business?

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The way clinical trials are conducted in the European Union will undergo a major change when the Clinical Trial Regulation (No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS).

flanders.bio, BioWin & BeCRO invite you to learn the important points you need to know on the impact of the upcoming EU Clinical Trial Regulation and the CTIS portal that will go live in December 2021, during a 1.5 hours session with keynote speakers.

Clinical operations, regulatory and start-up professionals will go home with an overview of the changes, the latest status with regards to the CTR pilot and practical, useful information on what to do differently.

This webinar is offered free of charge.

Speakers

  • Greet Musch - FAGG/FAMHP/AFMPS

Mrs Greet Musch is and Industrial Pharmacist and obtained a PhD in Pharmaceutical and Biomedical Sciences at the Vrije Universiteit Brussel.

She joined the Pharmaceutical Industry (research-oriented) for 8 years where she was responsible for the chemical and pharmaceutical analytical activities related to the development of new, innovative drugs. She moved to the Federal Public Health Services as a senior quality assessor and assisted in several projects related to EMA/CHMP.

Since August 2004 she was in charge of the R&D department within the Federal Agency of Medicines and Health Products in Belgium. As of February 2009, she has been appointed as Director-general for the DG Pre-authorisation. She is involved in different working groups related to unmet medical needs, early acces and clinical research in a broad sense (e.g. member of the Clinical Trial Facilitation Group).

  • Ludwig Everaert - Archemin

Archemin’s General Manager, Ludwig Everaert, earned a degree in Pharmaceutical Sciences and a postgraduate in Marketing and Business Administration. After 6 years of working as a Senior Clinical Research Associate, he joined Faulding Pharmaceuticals where he was the Scientific Affairs Manager for 4 years.

Based on this professional experience, he founded Archemin’s predecessor MPI in 1999. The company currently employs 19 experts. He is a member of the Belgian Industrial Pharmacists Association, Association of Clinical Research Professionals, the Belgian Regulatory Affairs Society and the European Medical Writers Association. Ludwig has very comprehensive experiences in the fields of pricing and reimbursement, clinical trials, regulatory affairs, medical information, pharmacovigilance and medical writing. He has written more than 150 preclinical and clinical expert reports. He is a scientific advisory board member for several emerging pharmaceutical companies.


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