Strategy in Drug Regulatory Affairs Course
19 - 20 October 2017
Riga, Latvia

 

LEARNING OBJECTIVES

  • Gain advanced tools necessary to optimise and maintain your regulatory procedures
  • Latest changes in legislation
  • Facilitate improvement in your review and maintenance procedures
  • Improve your day-to-day management of regulatory affairs 
  • Identify common problems and solutions through open discussions
  • Tackle the challenges of type II Variations under the MRP/DCP/CP

WHO SHOULD ATTEND

Anyone working within the field of regulatory affairs at management level or above:

  • Regulatory Affairs Manager
  • Strategy Management
  • Regulatory Affairs Officer
  • Quality Manager
  • Regulatory Affairs Specialist
  • Regional Coordinator
  • Regulatory Affairs Associate
  • Development Pharmacist
  • Pharmacovigilance Manager
  • Regulatory Affairs Attorney
  • Regulatory Affairs Executive
  • Project Managers

YOUR DISTINGUISHED TRAINER

Andrew Willis
Andrew Willis is a regulatory expert with 31 years of experience in pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects. His experience is wide ranging, and will facilitate your under- standing of fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management. Andrew has a wealth of experience which he will share from his multiple roles he has been involved with in the pharmaceutical industry, including:

  • Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus
  • Orphan drug registrations of vaccine products and synthetic molecules
  • NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)
  • Support for NBE during clinical phases and CMC support for a Biosimilar

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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.