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Holiday Inn London Kensington Forum

Oct 22, 2014 8:00 AM - Oct 24, 2014 5:15 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

Biopharmaceuticals, Biosimilars and Advanced Therapies - Development and Regulatory Framework in Europe

Agenda

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 8:45 AM

WELCOME AND INTRODUCTION

8:45 AM — 10:30 AM

Session 1: REGULATORY PATHWAYS FOR CLINICAL TRIALS, LEGAL ASPECTS, SCIENTIFIC ADVICE AND MARKETING AUTHORISATION OF BIOPHARMACEUTICALS IN THE EU

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 12:30 PM

Session 2: DEFINITION AND CHARACTERISTICS OF BIOPHARMACEUTICALS

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 3:30 PM

Session 3: THE QUALITY REQUIREMENTS FOR BIOPHARMACEUTICALS

1:30 PM — 3:30 PM

Session 8: THE CLINICAL DEVELOPMENT OF BIOPHARMACEUTICALS

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 5:00 PM

Session 4: GROUP DISCUSSION ON TYPICAL CMC ISSUES

5:00 PM — 5:30 PM

Session 5: ADVENTITIOUS AGENTS’ SAFETY EVALUATION AND EDQM TSE-RELATED CERTIFICATION

5:30 PM — 6:00 PM

QUESTIONS AND ANSWERS

6:00 PM — 7:00 PM

DRINKS RECEPTION

8:30 AM — 10:30 AM

Session 11: REGULATORY PRINCIPLES OF DEVELOPMENT OF BIOSIMILAR MEDICINAL PRODUCTS

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 1:00 PM

Session 12: REGULATORY PRINCIPLES RELEVANT FOR ATMPS AND CURRENT EXPERIENCE WITH MARKETING AUTHORISATION APPLICATIONS AND CLINICAL TRIAL APPLICATIONS

1:00 PM — 2:00 PM

LUNCH

2:00 PM — 2:30 PM

QUESTIONS AND ANSWERS

2:30 PM — 3:15 PM

COURSE ASSESSMENT

3:15 PM — 3:45 PM

COFFEE BREAK

3:45 PM — 5:15 PM

Session 13: OUTLOOK

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