Management

Founded by seasoned executives with decades of experience in pharmaceutical corporate management and consulting, EPMC Pharma is supported by a network of experts, chosen for their specific competency in the European regulatory environment.

Working with EPMC Pharma is the opportunity to partner with a pragmatic and experienced results-oriented team.

 

Anne Soetemont, PharmD

Director, Research and Development, EPMC Pharma

Anne Soetemont is co-founder and Director, Research and Development of EPMC Pharma.  Before creating EPMC Pharma, Anne Soetemont worked for Schering-Plough, where she was EU Manager, Global Regulatory Affairs.

Her experience covers:

  • Preparation, review of new applications, variations, post-approval commitments or renewals with the Headquarters/local European subsidiaries for centralized (biotech products) and non-centralized products in conformity with EU legislation
  • Submission of documentation to the EMA
  • Global regulatory strategy
  • Contacts and meetings with the Health Authorities in Europe and the US
  • Subjects matter expert: European Paediatric regulation and Orphan Drug regulation

Anne Soetemont holds an honours degree in Pharmacy degree and a Post-Graduate Diploma in "Regulation of health care products in the European Union", in "Assessment and negotiation of health care products and services" and in "Evaluation of Medicinal Products for Children".

Since 2008 Anne has worked extensively to service the requirements of US based organisations seeking pragmatic advice on how to manage their European regulatory processes and a number of European headquartered organisations seeking to benefit from her skills, in particular in paediatric medicines.

 


Network of partners and experts

EPMC Pharma through its network of Partners offers high expertise in European Legal, Medical, Pharmaceutical and Regulatory Affairs:

  • A team of highly qualified professionals (Lawyers, MDs, PharmDs, PhDs, ... ) with significant experience in Pharma Companies, Regulatory Agencies and Universities
  • A network of European Experts specialized in Medicinal Product Development, Regulatory Affairs and R&D Strategies
  • A group of lawyers specialized in Pharmaceutical Law, Intellectual Property, Patents and Supplementary Protection Certificates
  • Access to European Research Networks:
  • Pharmaceutical Development
  • Clinical Research (including Paediatric Clinical Research)