Strategy in Drug Regulatory Affairs Course
22 - 23 November 2018
Riga, Latvia



  • Gain and consolidate the information required to stay current with European regulations
  • Implement and maintain procedures required to comply with current European regulatory laws
  • Attain the advanced information needed for the detection, assessment, understanding and prevention of adverse effects of medicines
  • Improve your maintenance and training systems
  • Correctly label products for sale within and outside the European Union
  • Reduce the time taken for a product to go to market


  • What’s new in regulatory affairs?
  • Regulatory Strategy and Impacting Factors
  • Regulatory Influencing Factors and Impact on Strategy
  • Review procedure for CTD and eCTD
  • Understanding Submission Procedures
  • Pharmacovigilance for Regulatory Affairs
  • Labelling Regulations
  • Analysis of the Control and Management Required for Manu- facturing and Quality Control Testing of Current and New Products
  • Advanced Product Lifecycle Management
  • Understanding Regulatory Involvement in Clinical Studies

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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.