Pieter has been with NDA since 2013 and has an in-depth knowledge of vaccines and evaluating new medicinal products covering cardiovascular, nephrology, diabetes, psychiatry, and orphan medicinal products. Sharing his knowledge & providing expert guidance on how vaccines should be developed, registered, implemented and on the market.
Key Areas Of Expertise
- Detailed knowledge of the European approval system including the European Medicines Agency (EMA)
- Clinical documentation requirements to support European Clinical Trial Applications (CTA) and Marketing Authorisation Applications (MAA)
- Design of clinical development plans
- Scientific and strategic aspects
- Professional presentation skills and extensive teaching experience
- Pieter was an Associate Professor at the University of Namur, Belgium.
- Has been asked by numerous universities to give courses on regulatory affairs: Universities of Lausanne, Siena, Paris V, Antwerp, Ghent, Leuven and Brussels
Before Joining The NDA Advisory Board
Pieter was a member of the Committee for Human Medicinal Products, in Belgium; Vice-Chair of the Committee for Human Medicinal Products, Vaccines Working Party; EU representative at various meetings and conferences including the World Health Organization; a General Practitioner, and Belgian Regulatory Agency member.
He was also engaged by the Belgian Competent Authorities for the registration of Medicinal Products. First “General Inspectorate for Pharmaceuticals” later transferred to the new Federal Agency for Medicinal and Health Products (FAMHP; FAGG; AFMPS)
Recent Publications
Berten Ceulemans, MD, PhD, Marc Boel, MD, Katrien Leyssens, BM, Carolin Van Rossem, BM, Pieter Neels MD, Philippe G Jorens, MD, PhD, Lieven Lagae, MD, PhD; Successful use of fenfluramine as an add-on treatment for Dravet syndrome. Epilepsia 2012
Pieter Neels, Pierre Van Damme, Marc van Ranst, Jean-Michel Dogné; Human papillomavirus vaccines: understanding the benefit-risk: a recent article in the “Annals of Medicine” proves, editorial to “Annals of Medicines” on request of the Chief-Editor.
Annette Rida, Abha Saxena, Abdhullah H. Baqui, Anant Bhan, Julie Binese, Marie-Charlotte Bouesseau, Arthur Caplan, James Colgrove, Ames Dhai, Rita Gomez-Diaz, Shane K. Green, Gagandeep Kang, Rosanna Lagos, Patricia Loh, Alex John London, Kim Mulholland, Pieter Neels, Punee Pitisuttithum, Samba Cor Sarr, Michael Selgelid, Mark Sheehan, Peter G. Smith; Placebo use in vaccine trials: Recommendations of a WHO expert panel.
Johansen K, Brasseur D, MacDonald N, Nohynek H, Vandeputte J, Wood D, Neels P; Where are we in our understanding of the association between narcolepsy and one of the 2009 adjuvanted influenza A (H1N1) vaccines?
Christine E. Jones, Flor M. Munoz, Hans M.L. Spiegel, Ulrich Heininger, Patrick L.F. Zuber,Kathryn M. Edwards, Philipp Lambach, Pieter Neels, Katrin S. Kohl, Jane Gidudu, Steven Hirschfeld, James M. Oleske, Najwa Khuri-Bulos, Jorgen Bauwens, Linda O. Eckert, Sonali Kochhar, Jan Bonhoeffer, Paul T. Heath, The Brighton Collaboration Immunization in Pregnancy Working Group 1. Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.
Pieter Neels, James Southern, Jon Abramson, Philippe Duclos, Joachim Hombach, Melanie Marti, Alanna Fitzgerald-Husek, Jacqueline Fournier-Caruana, Germaine Hanquet. Off-label use of vaccines.
Marc Baay, Thomas Ritchie, Pieter Neels Human challenge trials in vaccine development, Rockville, MD, USA, September 28–30, 2017, accepted for publication 1/3/2018 Biologicals
Arifa Kahn, Luca Benetti, Johannes Blumel, Dieter Deforce, William Egan, Ivana Knezevic, Philip Krause, Laurent Mallet, Dietmar Mayer, Philip Minor, Pieter Neels, Guanhua Wang.Report of the international conference on next generation sequencing for adventitious virus detection in biologicals.
Edwards K, Hanquet G, Black S, Mignot E, Jankosky C, Shimabukuro T, Miller E, Nohynek H, Neels P. Meeting report narcolepsy and pandemic influenza vaccination: What we know and what we need to know before the next pandemic? A report from the 2nd IABS meeting.
Birgitte K. Giersing, Chad K. Porter, Karen Kotloff, Pieter Neels, Alejandro Cravioto, Calman A. MacLennan How can controlled human infection models accelerate clinical development and policy pathways for vaccines against Shigella?
Pierre Van Damme, Ilse De Coster, Ananda S Bandyopadhyay, Leen Suykens, Patrick Rudelsheim, Pieter Neels, M Steven Oberste, William C Weldon, Ralf Clemens, Hilde Revets Poliopolis: pushing boundaries of scientific innovations for disease eradication.
Andrew J. Pollard1, Robert Sauerwein, Marc Baay, and Pieter Neels Third Human Challenge Trial Conference, Oxford, United Kingdom, February 6-7, 2020, a meeting report. YBIOL1540
Isabelle Bekeredjian-Ding; Wim Van Molle; Marc Baay; Pieter Neels Human Challenge Trial Workshop: Focus on Quality Requirements for Challenge Agents, Langen,Germany, October 22, 2019. YBIOL1541
Tomoko Matsumoto, Naoki Matsumaru, Paul Scuffham, Pieter Neels & Katsura Tsukamoto; Alternative New Mono-scaled Quantitative Benefit–Risk Assessment of Human Papillomavirus Vaccine in Japan; 06/2020 DOI 10.1007/s43441-020-00189-1
Marc Baay, Bruno Lina, Arnaud Fontanet, Arnaud Marchant, Melanie Saville, Philippe Sabot, Philippe Duclos, Joris Vandeputte, Pieter Neels; SARS-CoV-2: Virology, epidemiology, immunology and vaccine development.
Marc Baay, Pieter Neels, SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues.
