EU Clinical Trial Regulation (CTR)

Impact of EU 536/2014 & Annex VI on Clinical Trial Supplies

If you conduct clinical trials in the EU, you probably know the Clinical Trial Directive (CTD) is being replaced by the Clinical Trial Regulation (CTR) EU No. 536/2014. The new Regulation aims to harmonize clinical trial processes across the EU. Although it was introduced in 2014, implementation has been contingent upon development of a fully functional, centralized EU portal and database for clinical trials. It’s expected to go live in January 2022. Now is the time to understand and prepare for major changes in managing EU studies.

Join Xerimis for a webinar on Wednesday, June 23 from 11:00 AM–12:00 PM EDT, explaining Clinical Trial Regulation and how it impacts these two significant areas:

  1. Clinical Trial Application — The good news is there will be a single submission for all EU countries. But study sponsors must adapt to new processes and specifications per the Clinical Trials Information System (CTIS).
  2. Packaging and Labeling — Stricter laws under Annex VI will create packaging and labeling challenges. In particular, considerations must be made for updating expiry dates on IMPs and auxiliary products.

We’ll also walk you through the overlap period for when CTD and CTR will run in parallel, and we’ll discuss some clinical trial supplies (IMP) record-keeping pitfalls you may wish to avoid under the new Regulation for Trial Master File.

You’ll have the opportunity to ask questions through live messaging, which will be answered during our Q&A session or post-webinar.

Register Now


About the Presenters

Carol Sue Bernardo
Chief Executive Officer & Managing Director
Xerimis US, UK & NL

Carol Sue oversees all departmental operations for the three Xerimis entities. Her industry experience spans 20 years, including leadership positions in clinical programs prior to working for Xerimis. Since stepping into her role as CEO of Xerimis US in 2014, she has ushered a period of unprecedented geographic expansion, sales growth, and capability improvements, while helping redefine the standards of clinical packaging and distribution. Carol Sue is a member of the DIA (Drug Information Association), ISPE (International Society for Pharmaceutical Engineering) and AAPS (American Association of Pharmaceutical Scientists).

Tony Moult
Head of Quality (interim)
Xerimis UK

Tony has over 35 years’ experience in clinical trial supplies. He’s held leadership positions in Operations, CTS Project Management, and Quality for a range of companies. His expertise in Clinical Trial Regulation EU 536/2014 stems from having formed and led the IMP GMP sub-team for EFPIA (European Federation of Pharmaceutical Industries and Associations) and its response to the new Regulation and Annex VI. Although a passionate supporter of the objectives of CTR, he remains actively involved in industry efforts to mitigate some of the issues it creates in developing medicines for patients.