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Seminar 9: Good regulatory affairs practice: communication skills, project management and tools for the daily practise

Course Description


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.


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


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


Day 1: Thursday, 08 October 2015

09.15 - 09.30 Welcome and introduction (Gertrud Thormann, The Hst Consulting Network GmbH)

09.30 - 10.30 Conducting effective meetings (Gabriele Dallmann, EUCRAF and Biopharma Excellence; Gertrud Thormann, The Hst Consulting Network GmbH)

Processes of preparation, conduct, rehearse and debriefing
Selection of attendees
Scenario preparation
Mandates for decision making

10.30 - 10.45 Coffee Break

10.45 - 11.45 Agency Code of conduct (Gabriele Dallmann, EUCRAF and Biopharma Excellence)

The Code of Conduct of agencies
Conflict of Interest
Transparency (EU), the Freedom of Information Act (USA)
Disclosure of data
Exchange of information with agencies

11.45 - 12.45 Regulatory intelligence and document management (Robert Schultz-Heienbrok, Xendo)

Regulatory intelligence and knowledge management
The Master Dossier
Data repository
Dossier compilation and submission
TIGes - e-submissions practilaties
The EU Telematics Strategy

12.45 - 13.30 Lunch

13.30 - 14.30 continued

14.30 - 14.45 Coffee break

14.45 - 16.15 Interaction of central project management with regulatory affairs (Gabriele Schricker, Wilex AG)

Goals of typical project managements
Types of time lines
Data collection
Interaction with external service providers

16.15 End of Day 1

16.15 Start of Sightseeing and Pre-Graduation Party of the fourth EUCRAF Course

Day 2: Friday, 09 October 2015

09.15 - 11.15 The regulatory affairs professional (Silvia Pfaff, Novartis)

Function and tasks

11.15 - 11.45 Coffee break

11.45 - 13.15 The Regulatory Professional at the interface (Kathy Hartmann-Campbell, Communication Training and Coaching)

Effective interpersonal communication
Intercultural communication
Collaborative communication

Good practices for virtual and global communication

13.15 - 14.15 Lunch

14.15 - 16.15 continued

16.15 - 16.45 Coffee break

16.45 - 18.45 Psychological aspects of project management (Violetta B. Kyburz, Fishawack Archimed AG, Basel/Zofingen)

18.45 End of Seminar 9

Entry Requirements

English language knowledge

Course Fees

1.400 EUR regular fee, 920 EUR for academic institutions/government (+19% German VAT)

Email Enquiry

Recipient: European Centre of Regulatory Affairs, EUCRAF
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