Date: 23 May 2023
Time: 09:00 - 10:30 (BST)
Course overview
Over the course of this webinar, our expert speakers Britt Vermeij and Katja Pecjak will guide you through the following aspects:
Current process of product information life cycle
How will new legislative proposals affect the future of product information (PI)
Maintaining the content of the PI
Conversion of the PI to ePI
Moving to Electronic Product Information Life Cycle
Regulatory process for the assessment of the ePI
ePI Portal
Dissemination of the ePI
The webinar will take place over the course of 90 minutes, with a one-hour presentation, with 20 minutes for a Q&A session with our webinar presenters, followed by a 10-minute assessment.
Audience
Delegates from the regulatory affairs industry who wish to obtain a better insight into the regulatory frameworks in Europe.
Regulatory professionals who wish to gain a comprehensive understanding of the subject.
Speakers
Britt Vermeij
Britt studied pharmacy at the University of Utrecht in the Netherlands. In 2001, she started working for Teva in the Dutch Regulatory Affairs Department, and in 2005 she was promoted to be in charge of the whole department. In 2009 she was made the Head of Regional Regulatory Affairs, managing Western European local regulatory affairs. In 2012 she took on a role with the EU Regulatory Intelligence and Policy unit, being the EU regulatory affairs project lead for projects like Brexit, ePI and FMD. She joined the Inter-association taskforce (IATF) on ePI in 2017, became the Vice-Chair of the Inter Association Task Force (IATF) in 2021 and Chair in 2022.
Katja Pecjak
Katja has a MSc in Pharmacy and has been with Billev Pharma East Ltd. since September 2008, where she started as a Director of Regulatory Affairs and EU QPPV. In July 2022 she was invited to join as a subject matter expert in the European Medicines Agency (EMA) ePI Pilot Project as Industry representative. She is a member of Medicines for Europe working groups (RSAC, PhV, ePI), TOPRA and she is an ePI Topic Group Lead in IRISS Forum. From 2010-2014 she was also a member of the EMA eSubmission Change Control Board, which saw the implementation of the new EU telematics governance structure.
Over the years she has been involved in building regulatory strategies and handling various regulatory procedures, including managing the life cycle of product information. Having worked in regulatory affairs and pharmacovigilance, she has an outstanding overview of telematics which gives her a great insight into the impact this has on pharmaceuticals processes.
Non-Member: £114 (Excluding VAT)
Member: £70 (Excluding VAT)