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Seminar 8: Scientific advice, regulatory strategy and health technology assessment

Course Description


According to the records of the EMA, constantly 25% of newly developed medicinal products submitted to the centralised authorisation procedure in Europe fail. This high failure rate is remarkable taking into account all the efforts installed in Europe within the 15 years from the time the EMA had been inaugurated. Numerous incentives are in place to stimulate regular pre-submission interactions with agencies to discuss the compliance of development programs with regulatory principles. Regulatory guidelines for all areas of drug development are available describing the regulatory standards. In order to translate these efforts into higher success rates of marketing authorisations an essential component of the overall regulatory strategy is the establishment of regular cross-functional interactions between teams of drug discovery and development, pharmaceutical development, marketing. Regulatory affairs should play an important role in this process. Health technology assessment is another increasingly important aspect of drug development, which requires earlier consideration in development concepts in the future. The seminar addresses concepts and tools by which strategic bridging is established and conducted efficiently in practice throughout the life cycle of the medicinal product.


- Regulatory strategy and global positioning of newly developed and existing products
- Pre-marketing interactions with regulatory agencies: scientific advice and pre-IND procedures
- Concepts and tools for bridging cross-functional teams
- Regulatory strategy for the introduction of changes in the manufacturing process
- Intellectual Property Rights
- Health Technology Assessment


- Reduce critical set backs in registration procedures by a successful scientific advice strategy and anticipating questions from regulators
- Lead and conduct appropriate scientific advice activities
- Understand how to plan and organize pre-authorisation interactions with regulatory authorities
- Understand the scientific advice process at the EMA and the pre-IND process at the FDA and the relevant dossier requirements
- Learn to plan, establish and conduct regular cross-functional regulatory forums from the early stage of development on
- Understand the principles of Health Technology Assessment and its implications on development programms and regulatory strategy


Day 1: Wednesday, 02September 2015

09.15 - 09.30 Welcome and introduction (Gabriele Dallmann, EUCRAF)

09.30 - 11.00 Regulatory Strategy (Jacques Mascaro, Merck Serono)

What is a regulatory stategy and when is it needed?
Which implication a global development has for a company and for the agencies involved?
Stakeholder and liaison functions
Active participation in development of new requirements
Choice of submission type and procedure
Management of product life cycle
Regulatory risk evaluation

11.00 - 11.30 Coffee break

11.30 - 12.45 continued

12.45 - 13.45 Lunch

13.45 - 15.30 A cross-functional strategic forum to support decision-making for regulatory processes (Susanne Heiland-Kunath, Takeda)

Life cycle of development projects
Regular interactions of regulatory affairs, clinical development, marketing, pharmaceutical development, pharmacovigilance
Tools, teams and deliverables
Preparation, briefing book, questions, discussions, minutes, internal communication
Gap analysis of data packages available for regulatory submissions
Involvement of external experts

15.30 - 16.00 Coffee break

16.00 - 17.30 Regulatory strategy for the introduction of changes in the manufacturing process (Josefine Buth, Biotest AG)

What important is in the manufacturing process
Planning changes of manufacture and comparability projects
When to demonstrate consistency
When to introduce a pre-clinical and clinical bridging study
Change control processes in practice

17.30 End of Day 1

18.45 Get-together with food and wine

Day 2: Thursday, 03 September 2015

09.15 - 10.30 HTA as a new element of the regulatory strategy - national requirements and European initiatives (Bruno Flamion, NDA Regulatory Advisory Board, University of Namur)

Reimbursement in Europe
Considerations on how to design clinical development programmes to be used for approval and HTA

10.30 - 11.00 Coffee break

11.00 - 11.30 continued

11.30 - 12.30 The regulatory affairs department at the interphase – cooperation with the market access department and its role in HTA (Beate Schäfer, Bristol Myers Squibb)

12.30 - 13.00 Discussion round on HTA

13.00 - 14.00 Lunch

14.00 - 15.30 An introduction about patenting biopharmaceuticals and freedom-to-operate studies (Denis Bourgarel, European Patent Attorney & French Patent Counsel)

What can be patented? The patentability criteria
For what purposes? What would by the scope of my patent exclusivity? Differences with data exclusivity?
The consequence of third party existing patent rights for my drug development
Patenting mAb as a case

15.30 - 16.00 Coffee break

16.00 - 17.15 Regulatory protection of medicinal products (Heike Wachenhausen, Wachenhausen Rechtsanwälte, formerly Novartis)

Regulatory data exclusivity and lifecyle management
PIP compliance and SPC extension
Market exclusivity for orphan drugs

17.15 End of Day 2

For Full Course students:

17.15 - 18.00 Introduction of Homework (Simon Day, CTCT)

Day 3: Friday, 04 September 2015

09.15 - 10.15 Strategic considerations on interactions with regulatory agencies (Simon Day, CTCT)

Examples of how to plan national and EMA scientific advice activities

10.15 - 11.00 Scientific advice from national competent authorities (Jan Müller-Berghaus, Paul-Ehrlich-Institut)

Experience and process followed at the German competent authority, the Paul-Ehrlich-Institut

11.00 - 11.30 Coffee break

11.30 - 13.00 Interactions with regulatory agencies in the EU to receive scientific advice (Jan Müller-Berghaus, Paul-Ehrlich-Institut)

The procedure of the European scientific advice at the EMA
Process and experience
Documentation, discussion meeting
Follow-up and clarification
EU/US paralell Scientific Advice
The EMA´s Innovation Task Force

13.00 - 14.00 Lunch

14.00 - 15.30 Interactions with FDA in the pre-IND process (Benita von Glahn, Boehringer Ingelheim)

Pre-phase I and post-phase II meetings
Preparation, documentation, meeting, telephone conference, written procedure

15.30 - 16.00 Coffee break

16.00 - 17.00 Interactive panel discussion: Interactions of companies and agencies in the development of biopharaceuticals

Benita von Glahn

Jan Müller-Berghaus

Simon Day

17.00 End of Seminar 8

Entry Requirements

English language knowledge

Course Fees

2.100 EUR regular fee, 1.320 EUR for academic institutions/government (+19% German VAT)

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Recipient: European Centre of Regulatory Affairs, EUCRAF
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