Achieving Regulatory Success in Europe

Building US foundations into successful EU submissions

Dawn Spark, BSc. MA, MTOPRA, Senior Regulatory Affairs Consultant
Nigel Scott, PhD. MTOPRA, Associate Director, Regulatory Affairs

You are familiar with the US regulatory requirements and now you are thinking about how to successfully use your IND in Europe. But where do you start? And what are the key regulatory challenges you are likely to encounter?

This workshop will provide an overview of the regulatory environment for conducting clinical trials in Europe and the support available to help successfully transition an investigational medicinal product from the US into Europe, including the financial incentives that are available for small and medium-sized enterprises (SME). The speakers will also highlight areas where strategic planning and careful consideration is required, such as the new regulatory requirements for addressing the pediatric population in clinical development plans.

Representatives from Regulatory Affairs, CMC, Clinical Operations, Clinical Supplies Distribution, Data Management, Medical Writing and Statistics may benefit from participating in this workshop.

Participants will be able to hear presentations and discuss:

• Introduction To Europe (National Authorities and the EMEA)
• Regulation of clinical trials in Europe
• Adding European sites to a clinical study on an IND
• The Clinical Trial Application
• Scientific Advice (National Authorities & EMEA)
• The Pediatric Implementation Plan
• Transatlantic cooperation between FDA & EMEA
• Assistance for small enterprises
• Gaining Orphan Drug Status
• Conditions For Data Exclusivity

Register for any of these workshops now!

Tuesday, May 13, 2008 (11:30am - 1:30pm)

Garden Court Hotel
520 Cowper Street
Palo Alto, CA 94301
Telephone: (650) 322-9000

Thursday, May 15, 2008 (11:30am - 1:30pm)

Hamner Conference Center
North Carolina Biotechnology Center
15 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-9366

Friday, May 16, 2008 (8:30am - 11:00am)

Residence Inn, Marriott
6 Cambridge Center
Cambridge, MA 02142
Telephone: (617) 349-0700

Tuesday, May 20, 2008 (11:30am - 12:30pm EST / 4:30pm - 5:30pm GMT)

Online Webinar Session