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Filing Variations

15 - 16 June 2020

Barbizon Palace, Amsterdam, The Netherlands

Managing regulatory change for filing variations is a complex and challenging procedure. The latest requirements have highlighted the need for successful variations strategies across regulatory teams. Have you addressed the changes you need to make?

This two day course will teach you how to optimise your procedures for faster, streamlined and compliant submissions.

The course is packed with exercises and case studies to meet your regulatory goals and tackle your everyday challenges.

Clarify the latest Variations revisions:

  • Formulate Variations procedures that achieve faster approval
  • Manage the practical hurdles of submitting your Variations on time and with the right supporting data
  • Understand the impact of the CTD on your Variation dossier
  • Collect and present complete information on your Variations
  • Streamline your Variation procedures for international applications
  • Tackle the challenges of type II Variations under the MRP

Sumaiya Patel

Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.

This course will be beneficial to Regulatory Affairs personnel who take part in filing variations such as:

  • Regulatory Affairs
  • Dossier registration department
  • Product Information
  • RA compliance
  • Personnel from other disciplines who have an impact on the process of filing Variations, such as manufacturing, development, clinical safety and pharmacovigilance.

“The case studies were refreshing and gave the opportunity to think and use information we learned from the experience. Thanks a lot for the good training course!” Regulatory Affairs Manager, Takeda Latvia

“The interactive aspect and the practical sessions were particularly enjoyable.” Regulatory Affairs Executive, Bimeda

The interaction and discussion of the particular ‘real-life’ examples as well as sharing experiences with different countries was very beneficial.

Senior Regulatory Affairs Officer, HAL Allergy

The fact that there were small groups, with great content and hands-on exercises, made it a very good course.

Global CMC Regulatory Affairs Consultant, Bioreg Consultancy Limited