Clinical and Regulatory Operational Excellence Forum

The increasing complexities in today's drug development require a close link between Clinical Operations and Regulatory Operations to embrace working solutions and partnerships. This highly interactive forum will enable you to perform complex tasks to the highest operational standards to shorten turnaround times and reduce queries and re-creation in your development programmes.

We are bringing together experts across the fields of Clinical Operations, Records and Document Management, Pharmacovigilance and Regulatory Affairs. Moderated workshops will look at different ways to implement working solutions.

The meeting will be based on selected abstracts that showcase working solutions and will allow attendees to learn from implemented best practices.

Featured topics
-Clinical Operations, eTMF
-Regulatory Operations
-Pharmacovigilance
-Electronic Data Management
-Quality, CMC, Serialization, Compliance

Who should attend?

• Health Care- and RandD Professionals in the areas of Electronic Document Management, IT and Process Innovation
• Clinical Operations and Regulatory Affairs that want to excel in their day-to-day work
• RandD Quality Leads, as well as Trial Managers and Drug Programme Leads and Clinical and Regulatory Project Managers that need to get an overview of the latest gold standards in RandD Operational Excellence to set the standards for high-performing cross functional drug development teams
• New Technical Solution Vendors (data capture or data handling, software companies for data management) that want to showcase implementatoins utilising their solutions or want to understand and adopt to changing customer needs

Time: 8:00 am - 5:00 pm

URL:

Booking: https://go.evvnt.com/131262-1

Prices:

Member Early-Bird: EUR 1230
Industry Member: EUR 1430
Industry Non-Member: EUR 1585
Government/Charitable/Non-profit/Academia (Full-Time) Member: EUR 715
Government/Charitable/Non-profit/Academia (Full-Time) Non-Member: EUR 869

Speakers: Marta Arias-Salgado Executive Director; Global Clinical Trial Operation Merck Sharp and Dohme The Netherlands, Hans van Bruggen MSc Regulatory Affairs Scientist eCTDconsultancy B.V. The Netherlands, Michael Horn (PharmD) Head of Division Licensing 1 Bundesinstitut Für Arzneimittel Und Medizinprodukte Germany, Karen Jane Roy (MPharm) Senior Vice President Client Solutions Phlexglobal United Kingdom, Peter Schueler (MD) Senior Vice President Drug Development Services ICON Germany