Good Regulatory Affairs practice: communication skills, project management and tools for the daily practise

1. Good regulatory practice
2. Function, skills and performance of a regulatory affairs professional
3. Cross-functional communication and interaction
4. Agency meetings in practise
5. Project management, time lines
6. Data and document management
7. Tools for daily practise and conferences to attend



Learning Objectives

8. Understand the role and responsibility of the regulatory affairs’ professional
9. Understand the essential features of Good Regulatory Practice (GRP)
10. Understand the importance of interactions and interfaces for the overall success of a project – cross-regional, cross-functional, company-agency
11. Learn how to develop negotiation skills, to solve conflicts and to compromise adequately
12. Understand and conduct data and project management in regulatory affairs
13. Understand the important media tools to be regularly applied
14. Gain presentation skills for internal and external meetings, inclusive agency meetings
15. Get knowledge of the essential websites, media tools, industry associations and conferences relevant for regulatory affairs

Content

Knowledge of the subject matter is required to understand the science of the product under development, to facilitate the adoption of regulatory principles and to integrate teams involved and information gained in this process. Regulatory affairs is thus determined by its interdisciplinary character requiring individuals committed to processes which are deadline-determined. Scientific and administrative requirements need to be integrated into the development concept, gap analysis of data packages as compared to regulatory requirements are conducted, teams need to be integrated internally and the interphase between the company and health authorities needs to be handled appropriately. The conduct of an agency meeting is trained at this seminar. Particular capabilities in preparing regulatory documents are required since style and content are special due to the orientation along regulatory requirements. Project management skills, time line awareness, interaction and communication skills are essential. Strategic planning, the ability to anticipate problems, to analyse complex situations and to offer the optimal strategy to achieve a certain strategic goal in a timely manner become important as the career progresses. These skills are necessary to communicate adequately with partners internally and externally. Certain tools for daily work are presented and ways to exchange with colleagues are discussed.

Agenda

Day 1: Thursday, 11 October 2012 (10.00 - 17.30)