MEB Regulatory Science Policy 2020-2024

Are you already familiar with the Medicines Evaluation Board (MEB) Regulatory Science Policy 2020 – 2024 'Regulating with the knowledge of tomorrow'? Curious about the content? Then read the document (in English or Dutch).

The MEB Regulatory Science Policy was published by the MEB last May. It describes the strategic direction of our scientific activities, which help us to innovate and improve our assessment of medicines. Also attention is paid to strengthening the link between scientific research and education, (inter)national collaboration and topics such as implementation of research results and the participation of patients.

Eight main themes are identified which the MEB will focus on in the coming years. These are:

  1. Replacement, reduction and refinement of animal tests (3Rs);
  2. Advanced Therapy Medicinal Products (ATMPs);
  3. Data-driven assessment;
  4. Personalised medicine & biomarkers;
  5. Medical devices;
  6. Generics;
  7. Medicines used better;
  8. Safety and effectiveness after authorisation.

SAVE THE DATE! Next MEB Science Day – 17 February 2022

We would like to announce the next MEB Regulatory Science Day, on 17 February 2021. This day will be all about ‘Academic Drug Development’.

More information about the program and registration for this event will be available soon.

We hope that you will participate during this interesting event in the afternoon of 17 February 2022!

Nikolai C. Brun appointed as Affiliate Professor at CORS

Nikolai C. Brun (MD, PhD) has been appointed Affiliate Professor at the Copenhagen Centre of Regulatory Science (CORS) from 1 October 2021. Nikolai will continue to support CORS in its aims to evaluate the performance of drug regulations and regulatory instruments, develop new tools and methods to support regulatory decision-making, and produce evidence informing regulatory decision-making.

More information can be found on the CORS Website.

CORS Annual Conference

The Annual CORS conference entitled “Regulation and Access to Medicines in Orphan and Vulnerable Populations - Who Benefits, Who Doesn't, and Why?” will take place on 22 November 2021 in Copenhagen (in person).

The programme and registration link can be found on the CORS website.

RSNN annual workshop 2021

The annual Regulator Science Network Netherlands (RSNN) workshop will take place on 23 November 2021 from 13:30-18:30 at the Jaarbeurs in Utrecht (in person). Program and speakers will be announced soon at the RSNN website.

PhD promotion Lourens Bloem

On 24 November at 2.15 pm Lourens Bloem will defend his PhD thesis entitled "Evidence generation on benefits and risks of medicines and its impact on regulatory and downstream decision-making".

Lourens performed his research under the supervision of prof. dr. Aukje Mantel-Teeuwisse, prof. dr. Olaf Klungel, dr. Jarno Hoekman and dr. Menno van der Elst. The research addressed several aspects of evidence generation for regulatory decision-making, such as specific obligations for conditionally authorised medicinal products, post-authorisation regulatory actions, and impact on decision-making by health technology assessment agencies and healthcare professionals. Next to performing research for his PhD thesis, Lourens has been a pharmacovigilance assessor at the Medicines Evaluation Board from 2016 to 2020.

The PhD ceremony will be live-streamed. The link to this livestream will be available a week before the defense. The link will be shared in the Regulatory Science LinkedIn group.

Lourens Bloem

Learnings Initiative for Optimal Use of Big Data

On 30 November 2021, the European Medicines Agency will host a webinar on 'Learnings Initiative for Optimal Use of Big Data'. The objectives of this workshop include to:

  • review lessons learned from submissions of real-world data in regulatory applications and discuss future perspectives for big data submission;
  • discuss challenges of using innovative methods in the use of big data for regulatory purpose;
  • discuss mechanisms for stakeholders’ input on future developments.

The event will be virtual. To enable wide participation, the event will be broadcast and a recording made public. The registration process and the outline of the agenda will be available shortly at the EMA’s website.

2nd EU Big Data Stakeholder Forum

On 7 December 2021, the 2nd EU Big Data Stakeholder Forum will take place. The objectives of this Forum include to:

  • inform on current achievements and future plans;
  • listen to stakeholders’ views;
  • discuss areas for collaboration.

The event will be virtual. To enable wide participation, the event will be broadcast and a recording made public. The registration process and the outline of the agenda will be available shortly at the EMA’s website.