Negotiation and Writing Skills for Regulatory Affairs


The client was interested in improving their interactions with the regulatory agencies, both with regard to their verbal communications and also their written responses to questions arising during the review of regulatory submissions.

Course Outline

Day 1

1. The Basics of Negotiating
2. Teamwork Exercises - Telephone and e-mail Negotiations
3. Regulatory Negotiating
4. Workshop: Scientific Advice Paper


Course Description

This course provided training on written and verbal negotiation skills, such as dealing with scientific advice requests and the preparation of regulatory submission review responses. It also considered the skills needed to prepare suitable strategic arguments for presentation to a
regulatory agency when managing challenging issues and for internal negotiations with other functions within the company.

Day 2

1. Making your Strategy Clear

Team Workshops - Regulatory Negotiating

  • The Scientific Advice Meeting
  • The Regulatory Recall Meeting
3. Teamwork Exercise - Next Steps to Better Negotiating

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T: +44 (0)1276 671 166
F: +44 (0)1276 670 960

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RRG, Innovation House
Albany Park, Camberley
Surrey. GU16 7PL

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