New Feature Sessions for 2018!
Elevate Your Experience through Interactive Sessions
Joining DIA means joining conversations and driving change in the industry. DIA Europe 2018 opens up even more opportunities for dialogue within the programme sessions.
New DIAlogue Sessions:
Dynamic, outcome-focused sessions where stakeholders converge to solve a real problem.
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The Role of Unmet Need in Regulatory and Pricing Decision Making18 April, 10:30 - 12:0
Moderator: Jens Grueger, Head of Global Pricing and Market Access, F. Hoffmann-La Roche, Switzerland
In this dialogue session, we will explore two areas in detail:
1. A high unmet medical need usually gets easier reimbursement. Can stakeholders agree on a definition of high unmet need that would provide more predictability for all?
2. Should there be a different assessment of price relative to value in drugs that address areas of high unmet need? -
The New EMA First-in-Human (FIH) Guideline17 April, 13:00 - 15:30
Session Co-Chairs:- Salah-Dine Chibout, Global Head of Discovery and Investigative Safety (DIS) and Global Head Therapeutic Areas in Preclinical Safety, Novartis, Switzerland; Chair of InnoMeds, EFPIA
- Jan Willem van der Laan, Senior Assessor Pharmacology- Toxicology, MEB and EMA Chair of Safety Working Party, Netherlands
EMA has released the revised “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products” on the 25th July 2017. This new guidance will come into effect on the 1st of February 2018. During this session we will engage in a dialogue with the different stakeholders (e.g. regulators, industry, academics etc.) on the clinical and non-clinical aspects of the guideline. By reviewing case studies, we will aim for an aligned understanding and implementation of this new important document. .