The Pre-Conference Workshop

How to successfully plan and start a clinical trial
Date:	Monday, 08, June, 2009
Led by:	Dr. Hiltrud Horn Founder HORN Pharmaceutical Consulting
About the workshop:	This workshop will focus on the essentials of clinical trials and will give you practical advice on how to prepare the Clinical Trials Application (CTA) and how to successfully pass GCP-inspections. This workshop is focused towards those involved in the conduct of clinical trials such as Clinical Development, Project management, Regulatory Affairs as well as Quality Assurance and Quality Control.

Workshop agenda
13:00	Registration
13:30	Session 1: Clinical Trials in Europe Regulatory Requirements Challenges Practical Hints
14:15	Session 2: Clinical Trials Application IMPD/CTA Planning Preparation Submission
15:00	Coffee break
15:30	Session 3: GCP-Inspection – Part 1 Types of Inspections Important Documents Practical Hints
16:15	Session 4: GCP- Inspection - Part 2 Efficient Preparation Conduct Practical Hints
17:00	Conclusion
17:15	Close of workshop
About your workshop leader:
Dr. Hiltrud Horn	Dr. Hiltrud Horn, the founder of HORN Pharmaceutical Consulting, has more than 19 years of experience in the pharmaceutical and biotechnology industry. She is regularly invited to speak at conferences, workshops and seminars on the development and registration of new chemical entities and biotech products. Dr. Horn has successfully developed her activities in the field of international regulatory affairs, project management, drug product development, CMC, Quality Assurance, medical writing, GMP, GCP, GLP, preparation and submission of dossiers for clinical trials and for marketing authorization and post-marketing activities.
About your workshop company:
HORN Pharmaceutical Consulting offers GMP/GCP/GLP and regulatory services for the pharmaceutical and biotech industry. We have detailed Know-How in the planning and preparation of regulatory documents for submission to Authorities in Europe and US. Furthermore we support companies in the preparation and conduct of GMP and GCP-inspection. See www.horn-pharma.de for further details.