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HOW TO GET READY FOR THE NEW CLINICAL TRIALS LEGISLATION

Track:
Regulatory Science

Day & Time:
March 26, 4:00PM - 5:30PM (Central European Standard Time)

Session Number:
0104

Room Number:
Room E1

Type:
Session

Title:
HOW TO GET READY FOR THE NEW CLINICAL TRIALS LEGISLATION

Chair(s):
Sabine Atzor, RPh
Head of EU Regulatory Policies
F. Hoffmann-La Roche Ltd., Switzerland

Description:
The new Clinical Trials Regulation is likely to be adopted in 2014 and will become applicable two years thereafter. The new legislation is expected to bring significant improvements with a single submission to the EU database, a single (joint) assessment by all concerned Member States and a single decision by each Member State within competitive timelines. Member States decide how they organise the work between competent authorities and ethics committees. To gain experience, pilots have been conducted by Member States with an coordinated integrated assessment process involving competent authorities and ethics committees through the Voluntary Harmonisation Procedure as “VHP +”. As a trade-off for competitive assessment timelines, companies are expected to prepare complete submissions as not to risk the withdrawal of a submission.

Presentation(s) & Speaker(s):
Update of the Legislative Process
Nick Sykes, MS
Senior Director, Worldwide Safety & Regulatory
Pfizer Inc., United Kingdom

Experience by the Member States
Birka Lehmann, MD
Director and Professor, Head of EU & International Affairs
BfArM, Germany

Piloting a New Model as VHP(+) - experience from a company
Surendra Gokhale, PhD
Head of Clinical Trial Regulatory Management
F. Hoffmann-La Roche Ltd., Switzerland

How Companies Need to get Prepared
Elena Bolanos, PharmD
Senior Director, European Clinical Operations
Eli Lilly SA, Spain