Improving Efficiency within the Current Regulatory System: Results of the Escher Project

Date18/09/2014
VenueThe Pullman Hotel, Brussels, Belgium
AddressThe Pullman Hotel, Brussels, Belgium
ReferenceESCHER14

Online Booking

Online Booking

Jointly organised by TOPRA and DIA

A workshop to hear the results of the Escher report 'Improving the EU system for marketing authorisation; Learning from regulatory practice'

The Escher Project initiates research and policy debate on the development, marketing authorisation, reimbursement and use of medicines. Their goal is to facilitate patient access to medicines and innovative technologies that address public health needs.

Escher is TI Pharma's multi-stakeholder platform for regulatory science and dialogue. Currently, Escher is in the final phase of a project that explores a number of perceived bottlenecks in the regulatory system. The project will result in a wealth of information for regulatory improvement to benefit the development of products addressing priority medical needs. On September 18th, Escher will launch the resulting project report in Brussels at a joint DIA/TOPRA event. The project was jointly funded by EFPIA and AESGP. TI Pharma's contribution ensured that all project partners could operate in an independent manner and that relevant stakeholders were consulted.

During the first phase of this project, a wide-scale exploratory survey among companies was conducted. Respondents were asked to grade 91 regulatory areas on the degree of improvement needed. In addition, respondents were asked to elaborate on the highest scoring areas and to provide specific examples.

The survey results revealed opportunities for improvements across the entire regulatory system. The specific regulatory areas were ranked according to the mean scores, resulting in a top-12. Four areas were selected for in-depth analysis by a team of researchers at Utrecht University. Topics include new pharmacovigilance requirements, pediatric investigation plans, the conditional marketing approval pathway, and experiences with the Mutual Recognition and Decentralized Procedures. The results of these case studies will also be discussed in a broader context.

The final report will be published in September and aims to inform policy making at the European and national level. Under the TI Pharma umbrella, Escher will continue to provide the community with an independent multi-stakeholder platform for regulatory and HTA research that advances the development of socially valuable medicines.

Overview

The European Medicines Regulatory system is well developed and has achieved many successes in bringing medicinal products to the market to the benefit of patients and their health.

However it has been receiving criticism for not supporting true innovation enough, for being bureaucratic, and full of redundancies and inefficiencies, which impact timelines and development costs?

What of this is true, what is not? What could be improved and what needs to be changed?

This workshop, organised jointly by DIA and TOPRA, will address these important questions and bring an important contribution to the debate improving the regulation for the benefit of all stakeholders.

Key topics

  • The current Escher Project
  • The four workshop groups
    • o Paediatrics
    • o Conditional market approval
    • o Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP)
    • o Pharmacovigilance
  • Feedback from the four workshops with recommendations for future action

Working party

  • Andre Broekmans, Director of Escher, TI Pharma, the Netherlands
  • Peter Bachmann, Senior Expert, European Drug and Regulatory and International Affairs Federal Institute for Drugs and Medical Devices (BfArM), Germany
  • Jean Philippe de Jong, Escher Project leader, Exon Consultancy, the Netherlands
  • Angelika Joos, Executive Director, Global Regulatory Policy MSD (Europe) Inc., Belgium
  • Davina Stevenson, Gilead, United Kingdom
  • Susan Sandler, Senior Director, Regulatory Affairs (CRS), Parexel International Ltd, United Kingdom

In addition to the working party the other speakers and workshop facilitators will include:

  • Jacoline Bouvy - postdoctoral researcher, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands
  • Christelle Anquez AESGP
  • Pär Tellner EFPIA
  • Zaide Frias – EMA
  • Jarno Hoekman - postdoctoral researcher, Utrecht Institute for Pharmaceutical Sciences & Faculty of Geosciences, Utrecht University, the Netherlands
  • Sue Forda - Vice President, GRA International at Eli Lilly and Company, UK
  • Hans Ebbers - postdoctoral researcher, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands
  • Christine Eising - Novartis Consumer Health S.A., Switzerland
  • David Jefferys - EFPIA, Senior Vice President, Global Regulatory, Government Relations & Public Affairs and Product Safety, EMEA and Russia, Eisai Europe Limited, UK
  • Fergus Sweeney – EMA
  • Wouter Boon, assistant professor, Faculty of Geosciences, Utrecht University, the Netherlands
  • Jytte Lyngvig, Senior Vice President and Managing Director, DIA Europe, Middle East & Africa
  • Lynda Wight, Executive Director, TOPRA
  • Plus European Commission invited.

Background

Research from Escher, the TI Pharma platform for regulatory innovation, shows that within the current regulatory system there may be many places where regulations can be used in a more efficient and effective manner.

A number of case studies by researchers from Utrecht University conducted in collaboration with Escher show that in some areas, such as the Conditional Marketing Authorization pathway, regulations may not function in the way in which they were initially attended. Also, sometimes no clear picture exists of whether resources invested are providing 'value for money' (such as in the area of pharmacovigilance).

According to Escher, more detailed evaluation and monitoring of the regulatory system is needed and is currently lacking. This should bring public and private parties together in joint evaluations and assessments. Learning from the results of assessments such as these could benefit all parties involved: patients, regulatory authorities, companies, and health care payers.

During the launch event participants will learn about studies on the new pharmacovigilance requirements, Paediatric Investigation Plans, the Conditional Marketing Approval pathway, and experiences with the Mutual Recognition and Decentralized Procedures.

Leading experts from regulatory authorities, companies and government will reflect on the outcomes of these studies. Participants will have ample room for interaction and discussion in order to take home new insights on how to improve their daily operations. In break-out sessions we will work together in addressing a number of key questions for the future of the regulatory system and identifying ways forward. The outcomes of the meeting will be published in a white paper.

Downloads
Download the workshop programme