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.

 

Jacques De Waele

Director, EPMC Pharma

Jacques De Waele is the co-founder and a Director of EPMC Pharma.

As a senior manager with over 35 years of experience, Jacques had worked for large multinationals in different industries. His main areas of expertise are business economics and the relationship between business development and finance. His geographical experience spans North America, Europe and Africa.

Before joining EPMC Pharma, J. De Waele worked during 10 years for Schering Plough where he was Financial Director Benelux.

His extensive experience covers areas in and beyond effective management of the pharmaceutical sector: a respected speaker on management, he has also run seminars for executives on financial topics such as cash flow management and capital budgeting.

He is member of various professional, social and non-profit organisations.

J.De Waele holds a Master Degree in Economics from the FUCAM University of Mons where he followed a Post Graduate course in Operational Research.

 

Stefano Rossetti, MD, FPFM

Consultant in Clinical Drug Development

Stefano Rossetti is an independent consultant working with EPMC Pharma.

Almost 30 years of experience in Medical/Regulatory/Drug Development in multinational (British, French and USA) and national pharma  companies  and biotech companies.

Almost 11 years of experience at international level (Europe-Canada) and at headquarters level (biotech).

Strong experience in clinical trials (from phase I to phase IV), medical affairs activities, interaction with regulatory bodies (Europe, Canada and US), network of key OLs (advisory boards, expert meetings, Data safety monitoring boards, etc.), scientific/medical support to licensing and IP activities. Long lasting involvement in wide range of therapy areas (Oncology, CV, CNS, Respiratory/Allergy; GI, Immunology, etc.).

Fellow and/or member of several Pharma and Scientific associations in EU and USA.

Before working as a consultant at EPMC Pharma, he served as Vice President Clinical Development and Regulatory Affairs for 2 years and as VP Development since May 2003 in Newron Pharmaceuticals.

From 1999 to 2003, he was European Director of Product Development at Schering-Plough International (Europe/Canada/Middle East) with involvement in pre-clinical, medical, regulatory and marketing strategies for new drug development process (from early development phase to registration and market positioning).  From 1989 to 1999, Dr Rossetti was Medical and Regulatory Affairs Director at Schering-Plough Italy.

From 1984 to 1989, he was the Medical Director for SyntheLabo Italy. From 1981 to 1984, Dr Rossetti was the clinical monitor for Boots Italy.

Dr. Rossetti holds a degree in medicine and surgery and gastroenterology from Pavia and Milan Universities and is the author of several scientific publications.

Expert in Clinical Development and Clinical Strategies, Medical affairs activities.

 

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)