The 10th TOPRA Annual Symposium 2013

Delegates were welcomed to the three-day Symposium by TOPRA’s  Executive Director, Lynda Wight; Craig McCarthy, Chair of the Symposium Working Party and Helder Mota Filipe, Vice-President of the Executive Board of Infarmed, Portugal. 

The keynote speech was given by Andre W  Broekmans, BroekmansConsult, the Netherlands, on “Regulatory Affairs: Quo Vadis?” An experienced regulator looks to the future of the discipline – where is it going? The presentation examined the current and potential future regulatory system (with a focus on Europe) by discussing three broad themes: collaboration and globalisation; complexity; transparency.The collaboration between members of the European and wider regulatory community has enabled the creation of standards (such as ICH, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) which have allowed for common ground between different countries’ approaches to regulation of medical products and also inspections. In the future state there is a 

push to make the ICH guidelines more binding but also expand to current non-ICH countries. 

New legislation (for example in medical devices and human pharmacovigilance) has imposed a greater burden on drug development companies but is also welcomed in areas where previous guidance was lacking (such as in the post-approval phase). It was questioned whether we had gone too far with excess committees in the European Medicines Agency (EMA) and the lack of freedom to manoeuvre within the complexity of these committee structures. In the future it was proposed that the focus would be more on regulatory science within initiatives such as the Innovative Medicines Initiative (IMI) to look at new viewpoints for the current regulatory system. Other future developments include the use of more progressive/adaptive licensing, post-approval changes and the alignment of regulatory review with health technology assessment (HTA) review – to eliminate the need for two separate systems each with their own unique complex processes. Finally, with respect to transparency, delegates were reminded that medicines have an inherent risk and that there is a need to educate the public. The contentious issues surrounding data-sharing are about the release of the decision-making data to the public (specifically the data around the benefit–risk decision) balanced against the need to protect subjects to avoid the misuse and misinterpretation of data. The European Federation of Pharmaceutical Industries and Associations (EFPIA) concept of responsible data-sharing was commended for its pragmatic approach focusing on accountability.

Reference: The 10th TOPRA Annual Symposium 2013