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Dr. Jaap Laufer - Vice President, Public & Regulatory Affairs

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Jaap Laufer MD, PharmD, has 25+ years of experience in Regulatory and Medical Affairs at major pharmaceutical and technology-intensive medical device companies. He serves as Senior Regulatory Counsel to the Management or Board of several major medical device manufacturers, but also of venture capital funded companies.

In addition to working with Emergo Group, Dr. Laufer manages his own regulatory consulting firm serving medical device and IVD clients worldwide. He was also VP of Regulatory and Clinical Affairs for LipoMatrix, Inc. in Neuchatel, Switzerland. When Collagen Corp. of Palo Alto, CA, acquired LipoMatrix, he became their Vice President of Regulatory Affairs. Before he joined LipoMatrix, Dr. Laufer held a number of managerial positions of increasing responsibility within Pfizer. In this capacity he was responsible for regulatory approval and compliance, and medical matters concerning a wide variety of active and non-active medical devices.

On top of being an experienced auditor for compliance with ISO (accredited with ZLG) and FDA Quality System Regulations, Dr. Laufer managed many clinical studies, sometimes from inception to publication. He is a regular contributor and past Chairman of Regulatory Affairs Professional Society (RAPS), Europe (1993-1996) and a visiting teacher to the School of Pharmacy at the University of Southern California (USC).

Dr. Laufer is fluent in English, Dutch, German and French.

AREAS OF EXPERTISE:

  • Development and implementation of strategy for market approval and launch in all countries, in relation to their health care systems.
  • Development and implementation support of Clinical Studies Programs.
  • Design and implementation of Global Adverse Event Reporting Program.
  • Development and implementation of Quality Systems
  • Pre-acquisition screening and audit.
  • All medical and clinical aspects from early stage prototype through product launch and beyond.
  • All aspects of CE-marking strategy, except finance, marketing and sales (includes "conversion" from pharmaceutical to device status

AFFILIATIONS AND ACHIEVEMENTS:

  • Past President Europe, Regulatory Affairs Professional Society (1993-1996)
  • Member Expert Advisory Board, Committee on Classification, to the European Commission on Medical Devices (MDEG)
  • Past Member of Corporate Regulatory, Clinical and Quality Steering Committee, Pfizer Hospital Products Group
  • Past Member of Executive Committee, Collagen, Inc.
  • Member KNMP (Royal Dutch Society of Pharmacists)
  • Member KNMP (Royal Dutch Society of Medicine, College of Physicians)
  • Visiting Professor, University of Southern California (USC) School of Pharmacy (2003-Present)
  • Associate Professor, University of Cardiff, Wales for Regulatory Affairs (1998)

EDUCATION:

  • Ph.D. in Pharmacy, University of Groningen, The Netherlands
  • M.D. in Medicine, University of Nijmegen, The Netherlands.

HOME BASES:

  • California, USA
  • The Netherlands
  • Switzerland