The course is providing in-depth understanding of the hot topics in today’s parallel import industry of medicinal products. This course is catered for all companies involved in parallel import

LEARNING OBJECTIVES

  • Clarify the latest requirement for registration of PI medicines
  • Understand political and legal challenges in PI industry
  • Comprehend key issues surrounding successful or unsuccessful PI registrations
  • Manage quality and distribution issues to avoid non-compliance
  • Become an expert in PI reimbursements to achieve more access to products
  • Know the pitfalls in PI compliance: pharmacovigilance, GDP & GMP, labelling
  • Be aware of what to expect in the future of Parallel Trade

WHO SHOULD ATTEND

This course will be beneficial to all personnel working in Parallel Import & Trade companies, as well as Regulatory Affairs personnel in pharmaceutical companies manufacturing the finished product:

  • Regulatory Affairs
  • Product Information
  • RA Compliance
  • Batch releasing
  • Parallel Importers
  • Parallel Distributors
  • Personnel from other departments who have responsibilities in PI industry, such as manufacturing, government access, pharmacovigilance, quality, etc.

FULL INFORMATION

YOUR DISTINGUISHED TRAINER

Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

Heinz Kobelt holds the position of Director European Affairs of the EAEPC after having served as its Secretary General from February 2005 to April 2011. The European Association of Euro-Pharmaceutical Companies (EAEPC) is the representative voice of pharmaceutical parallel distribution in Europe. Through national association or individual company membership it encompasses some 70 companies from 21 countries in the European Economic Area (EEA). Before that, from 2001-2003, Heinz was Head European Government Affairs of Novartis International, located in Brussels. From 1990 – 2001, Heinz Kobelt worked as an international public servant in the Secretariat of the European Free Trade Association (EFTA), where he participated in the negotiations of the EEA Agreement and held various positions as economist and policy analyst. He was stationed in Geneva, and from 1992 in Brussels. Heinz holds a degree in economics (Dr. oec) from the University of St. Gallen, Switzerland.

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CANCELLATIONS: Confirm your cancellations in writing 3 weeks before the date and receive a 50% refund. Should you cancel between this date and 1 week before the date of the course regrettably you will not receive a refund. Customer may reschedule a booking to another date at a 100% rescheduling fee by advising Rephine Balticum of such rescheduling in writing. It may be necessary for reasons beyond the control and the organiser to alter the content and timing of the program or the identity of the trainers. In the unfortunate event that an event is cancelled Rephine Balticum are not liable for any costs incurred by delegates in connection with their attendance. This contract is subject to Latvian Law.