LEARNING OBJECTIVES

  • Understand the basis of EU legislation
  • Understand pharmaceutical regulatory dossier structure in EU
  • Clarify how different procedures work
  • Seed-up the MAA through effective selection of your drug registration procedure
  • Integrate CTD requirements from the start of your submissions
  • Compile and present the key information in your submission dossiers more efficiently
  • Improve your dossier compilation process through a systematic data collection strategy
  • Facilitate successful review of your dossier by preparing a strong dossier
  • Allow a smooth product development program
  • Gain faster response from the Regulators through better negotiations
  • Maintain your marketing authorisations by performing post-approval obligations on time
  • Learn how to prepare all regulatory documents electronically
  • Become familiar with in electronic regulatory submission tools

WHO SHOULD ATTEND

This course will be beneficial to:

  • Regulatory Affairs personnel
  • Dossier registration personnel
  • Product Information
  • RA compliance
  • Submission managers
  • Medical writers
  • Personnel from other disciplines who have an impact on the regulatory affairs processes, such as manufacturing, development, clinical safety and pharmacovigilance

YOUR DISTINGUISHED TRAINER

Dr Polina Dombure, Regulatory Affairs Consultant
Dr Polina Dombure runs her own regulatory affairs consultancy providing support and advice to achieve successful registration of medicines. She has worked in regulatory affairs for over 15 years, with prior experience in manufacturing of finished medicinal products, quality assurance and pharmacovigilance. Years of experience have allowed for developing a strategic approach to complex regulatory issues allowing for regulatory product management over the whole life cycle and improving efficiency in regulatory submissions, which she is now ready to share with Clients and Course participants.

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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.