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Accelerating Development of Biopharmaceutical Workshop 2015

Preliminary Programme
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Preliminary Programme

Accelerating development and approval of biopharmaceuticals – Pathway to successful marketing authorization

November 2015

Munich, Germany

Moderator: Dr. Diane Seimetz, Biopharma Excellence


11.30 - 13.00 Registration and welcome snacks and refreshments
13.00 - 14.30 Workshop
14.30 - 15.00 Coffee break
15.00 - 17.30 Workshop
17.30 End of the day
18.00 Transfer to the venue of the social event
18.30 Social event

SESSION 1: Elements and use of the Regulatory Development Plan and setting up the Regulatory Strategy

  • Why is a regulatory development plan and a regulatory strategy important?
  • Regular and expedited pathway options in the EU and US
  • US: fast track (development), breakthrough therapy designation (development), accelerated approval, priority review (approval) designation
  • EU: accelerated review process, approval under conditional or exceptional-circumstances, orphan medicinal product, adaptive licensing
  • Structure and elements of the regulatory development plan from early stage development throughout life cycle of a biopharmaceutical
  • Data protection and market exclusivity
  • Preliminary benefit-risk assessment and regulatory pathways as the basis for the identification of development and approval scenarios
  • Regulatory plan and strategy as key elements of management and development decision making practise throughout product life cycle
  • Practical implementation of the regulatory development plan
  • Q & A / Discussion

SESSION 2: The Target Product Profile (TPP) of a novel development candidate and of an approved biopharmaceutical

  • The content and structure of the TPP
  • The use of TPP as drug development and regulatory strategy tool
  • The global TPP
  • How to utilize the TPP on a regular basis to engage all disciplines in the development - from CMC to pre-clinic to clinic
  • Examples of a TPP of a novel biopharmaceutical candidate
  • Q & A / Discussion

SESSION 3: The Core Data Sheet and its use in development, decision-making and pharmacovigilance

  • The content and structure of the Core Data Sheet: indications, dosing, pharmacology, safety – is this all?
  • Global and life cycle label claims development based on the Core Data Sheet information
  • Examples of Core Data Sheet cases used to collect all relevant information from clinical trial protocols, reports, spontaneous adverse drug reaction reports and how to use them in practice
  • How to interlink the Core Data Sheet and the TPP?
  • Q & A / Discussion


08.30 - 09.00 Welcome Coffee
09.00 - 10.30 Workshop
10.30 - 11.00 Coffee break
11.00 - 13.00 Workshop
13.00 - 14.00 Lunch break
14.00 - 16.30 Workshop
16.30 End of the workshop

SESSION 4: Key factors driving the success of CMC, pre-clinical and clinical development of biopharmaceuticals

  • Typical issues in the establishment of the manufacturing process, specifically with external Contract Manufacturers
  • Formulation development – do you want to be fast or do you want to have the most optimal world conditions fulfilled?
  • Key considerations for non-clinical development planning and interactions with external Contract Research Organisations
  • How to avoid the failure – reasons for regulatory rejections
  • Clinical development program – what can be done to expedite it significantly
  • Best practice for adaptive trial design for biopharmaceuticals studies
  • Q & A / Discussion

SESSION 5: Best practice for fast conduct of clinical studies

  • Typical pitfalls in the conduct of clinical studies
  • Advantages of the selection of the CRO being really right for you
  • Planning the clinical trial design with the input of KOLs and of the CRO
  • Challenging the clinical trial design by advisory boards
  • Patient recruitment strategy
  • Countries and centres selection strategy
  • Planning for interim analysis in clinical trials and its impact
  • Experience on clinical operational - do’s and don'ts