MEB Day 2019

The annual MEB Day 2019, organized by the Medicines Evaluation Board, was held on 5 June 2019. Theme of the day was ‘Trust in medicines’. The MEB Day is intended for pharmacists, doctors, patient representatives, scientists and interested parties from the pharmaceutical industry and government.

There were plenty of workshops, presentations etc. in which various topics were discussed, like trust issues, pharmacovigilance and herbal medicinal products.

From the regulatory science perspective there was a workshop called ‘good use of opioids’. You will find more of this topic in the interview with Marcel Bouvy and Liesbeth Rook.

Collegedag 2019
Collegedag 2019
Hugo Hurts, MEB director.
Collegedag 2019
Bruno Bruins, minister for Medical Care, being interviewed by host Elsemieke Havenga.

FIGON Dutch Medicines Days 2019

The Dutch Medicines Days is the annual conference of the Federation for Innovative Drug Research Netherlands (FIGON) where partners from industry, institutes and government can present their findings, share new scientific content and strengthen their network.

The DMD were held on 23 and 24 September 2019, at a new location in Leiden. The general topic of this year was 'Innovation in pharmacological and pharmacotherapeutical research'. An important message throughout the whole programme was that multidisciplinary cooperation is indispensable.

On the 23rd of September the Regulatory Science Network Nederland hosted a session. The session was chaired by Peter van Meer (assessor at CBG-MEB, vice-chair RSNN) and Joop van Gerven (chair of the CCMO). Theme of the session was ‘Innovative monitoring technology in clinical trials: feasible approaches, valuable evidence’.

In four presentations, followed by a plenary discussion, current developments in monitoring and measurement technologies for clinical research were discussed. Furthermore, speakers debated on opportunities for optimising the value of innovative technologies for medicines development and regulatory decision-making. Ultimately, the discussion explored the implications for regulatory and Health Technology assessment with a special focus on the acceptability of new methods for evidence generation.

Speakers were: Matthijs Kruizinga, Research Physician (Juliana Kinderziekenhuis; CHDR), Tom Zwart, PhD Candidate (Dept. of Clinical Pharmacy and Toxicology - LUMC), Peter Mol, Principal Assessor (CBG-MEB), Lourens Bloem, PhD Candidate (Division of Pharmacoepidemiology & Clinical Pharmacology – UU) and Pharmacovigilance Assessor (CBG-MEB).

The full report of the meeting will be soon available on the RSNN website.

The MEB was also represented in the PhD student competition and the poster competition. Rosalinde Bot won the poster prize for the topic Use 1: Regulatory Affairs. You can find more information about her project here.

FIGON Days 2019

CORS Annual Conference 2019

The Copenhagen Centre for Regulatory Science (CORS) held their annual conference on 18 November 2019. Title of the conference was:

Public health and innovation – Is regulation a friend or a foe?

The conference focused on the role of regulation in both protecting public health and promoting innovation. The regulatory system has to take into consideration the protection of public health while, at the same time, ensuring that patients have timely access to medicines, including the ones that address unmet medical needs. 

Through a variety of presentations by invited speakers and very interesting discussions, it was explored and discussed what the implications of incentives and requirements set up by medicine regulations represent for innovation, public health and ethics.

CORS annual meeting 2019
CORS annual meeting 2019
Marieke de Bruin, PhD, Director of the Copenhagen Centre for Regulatory Science (CORS)

European Medicines Agency Workshop 'Regulatory Science to 2025'

A multi-stakeholder workshop on the human medicine aspects of its draft ‘Regulatory Science Strategy to 2025’ was held at the EMA on 18-19 November 2019. The purpose of the workshop was to discuss the outcome of the public consultation on the draft strategy, reflect on the prioritisation of core recommendations and identify concrete actions to implement the key goals and recommendations.

EMA’s ‘Regulatory Science Strategy to 2025’ was released for public consultation between December 2018 and June 2019. Around 150 individuals and organisations across a broad range of stakeholder groups submitted comments.

The draft strategy sets out working proposals on the key areas with which EMA intends to engage, in order to ensure that it has the regulatory tools to continue supporting the European medicines regulatory network and fulfil its ongoing mission in light of upcoming scientific challenges. The final strategy, expected in early 2020, will be a key contribution to the next EU Medicines Agencies Network Strategy (2020-2025).

More information on the workshop can be found on the EMA website.