Online on 23rd May 2023 (9:00-10:30 BST) TOPRA is going to host Katja Pečjak and Britt Vermeij talking on one of the hot topics in pharmaceutical industry which will potentially influence every European citizen. The webinar will present implementation challenges of Electronic Product Information, shortly known as ePI.
Over the course of this TOPRA webinar expert speakers Katja Pečjak and Britt Vermeij will guide delegates from the regulatory affairs profession who wish to obtain a better insight into the pharmaceutical’s regulatory frameworks in Europe 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 development of ePI is intended to improve access to up-to-date product information on medicines when and where it is needed. The European Medicines Agency, Heads of Medicines Agencies and the European Commission have developed key principles to guide the development and use of ePI in the EU. Here is how ePI have been outlined: benefits to public health, creates efficiency gains for regulatory systems, aligns with the existing legislative framework and complements the paper package leaflet, fits into the EU’s multilingual environment, and interacts with other ongoing digital initiatives at EU & global level.
The webinar is organized under supervision of TOPRA. TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs. TOPRA works with members internationally to enable and promote excellence across the healthcare regulatory profession.
Katja Pečjak, MSc Pharma has been with Billev Pharma East Ltd. since 2008, where she is currently Managing Director and EU QPPV. She was invited as a subject matter expert by the European Medicines Agency (EMA) to join ePI Pilot Project in 2022. Katja represents the pharma industry perspective on the project. Additionally, Katja is in the role of ePI Topic Group Lead in IRISS Forum. Her telematics role started back in 2010, when she was a member of the EMA eSubmission Change Control Board until 2014.
Britt Vermeij, MSc Pharma has been with Teva since 2001, taking on different regulatory affairs roles including managing several regulatory affairs departments. In 2012 Britt 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. Britt 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.