Course 1: Global Identification of Medicinal Products: Applied Principles and Practical Benefits from Compliance and Beyond
Vada A. Perkins, BSN, MS, MSc, RN
- Founder and Managing Principal
- Identifica, United States
Vada A. Perkins is the Founder and Managing Principal of IDENTIFICA LLC, an independent global regulatory consulting practice offering Global Product Lifecycle (GPLC) data governance solutions in conformance with regional regulatory requirements and international data standards to optimize business for clients from concept to execution.
- Regulatory Information Scientist
- eCTDconsultancy B.V., Netherlands
Michiel Stam is a Regulatory Information Scientist at eCTDconsultancy B.V. and has a strong focus on electronic submissions for Drug Regulatory Affairs and Pharmacovigilance. In this role he has lead various submission and information management projects for Pharma and Biotech companies. eSubmission projects include preparation and submission of initial marketing authorization applications and post-authorization maintenance for Agencies in the EU (CAPs, NAPs and MRP/DCP), US (NDA and BLA) and other regions, including GCC and Swiss Medic submissions. Since 2011 Michiel has worked on XEVMPD and IDMP (Identification of Medicinal Products) related topics, Registration Tracking and Semantic interoperability.
Frits Stulp, MSc
- Managing Director
- Iperion Life Sciences Consultancy, Netherlands
Frits Stulp is a well-known IDMP SME. Frits has 20 years of experience in the life sciences environment. Over the past 6 years Frits has been exclusively involved in regulatory processes, XEVMPD and especially IDMP. Frits is an enthusiastic communicator and educator, regular speaker at IDMP conferences and has been a member of the EMA ISO IDMP Task Force. He is a strong advocate for seeing the opportunities and possibilities of IDMP for industry, regulators and healthcare.
Andrew Marr, PhD
- Managing Director
- Marr Consultancy Ltd, United Kingdom
Managing Director, Marr Consultancy Ltd. Recognised expert in IDMP through work in ISO, EU IDMP Task Force, Conference Speaker and numberous engagements with top 25 pharma (and other pharma clients), software houses and service providers in the e-Regulatory space.
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