I am a veterinary consultant with 23 years of experience in regulation of veterinary medicines in EU.

As former chair of the veterinary medicines committee (CVMP) in the European Medicines Agency (EMA), and with 18 years of work in a Competent Authority followed by 5 years as consultant, I present:

• Unique insight in evaluation of veterinary medicines and vaccines from EMA, DKMA and VICH.
• In-depth understanding of decision-making processes and regulatory science in EU-procedures.
• Hands-on work experience with
  • EU centralised procedures, referrals, scientific advice, Maximum Residue Limits (MRLs), MUMS/Limited Market products, legislation, scientific guidelines EMA – VICH,
  • gap analysis for new products, drafting of expert reports, response to List-of-Questions, clinical trial protocols,
  • overview of regulation of innovative medicines, gene therapy, platform vaccines, diagnostics,
  • international negotiation, management of meetings with international scientific experts and steering of drafting groups.

• Training events for assessors and customers, conference presentations, publications, and regulatory consultancy meetings.
• CEO experience from a veterinary biotech and gene therapy company, including IPO and stock-market entry (2016-2020).
• Advisory board member. Board of directors collaboration.
• Diploma (BSc level) in management 2018; leadership, coaching, and public administration sector.
• Fellow of TOPRA. Member of Association of Veterinary Consultants (AVC).

On a personal note, I value pleasant and competent collaboration, honest communication, and meeting deadlines.

Please do not hesitate to contact me for a non-binding talk about your project and how I may help you.

info@centralvetpharma.com