Overview:
Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following advice from the Regulatory Authorities increases the probability of a positive outcome.
Why should you Attend:
Scientific advice is when the Regulatory Authorities gives advice to a company on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients. Choosing the right procedure for scientific advice (at the European Medicines Agency or at the National Authorities in the EU) and preparing well for the procedure is very important to assure your development program meets the requirements of the Regulatory Authorities. This webinar will address which procedure is best depending on the circumstances, and how to choose among the National Authorities. In addition it will cover the preparation of the meeting (including briefing document).
The aim of parallel scientific advice with HTA Bodies is to allow medicine developers to gain feedback from regulators and HTA bodies at the same time, early in the development of a medicine. This helps them to establish the evidence that both parties will need to determine a medicine's benefit-risk balance and value.
Areas Covered in the Session:
Who Will Benefit:
The aim of parallel scientific advice with HTA Bodies is to allow medicine developers to gain feedback from regulators and HTA bodies at the same time, early in the development of a medicine. This helps them to establish the evidence that both parties will need to determine a medicine's benefit-risk balance and value.
Areas Covered in the Session:
- Introduction
- Scientific advice at the EMA
- Qualification of novel methodologies
- Parallel scientific advice: EMA and FDA
- Parallel scientific advice: EMA and HTA bodies
- National scientific advice
- Briefing document for scientific advice
Who Will Benefit:
- Senior management
- Project Managers
- Medical writers
- CRAs and CRCs
- QA / Compliance personnel
- Investigators
- Clinical Research Scientists
- QA / QC Auditors and Staff
- Consultants
Speaker Profile:
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands.
He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
Contact Detail:
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/1KzUhWl
Comments