| Starts: | Monday March 29, 2010 at 8:00am |
|---|---|
| Ends: | Tuesday March 30, 2010 at 5:00pm |
| Event Type: | Training/Seminar |
| Region: | Washington D.C. Metro Area |
| Location: |
PERI Training Facility Arlington, VA US |
| Price: | $1,495.00 Register by 02/11/10 |
| Website: | http://www.peri.org/course_details.cfm?course=1980 |
| Industry: | pharmaceuticals |
| Keywords: | Eu, Japan, Maa, Clinical Drug Development, Ich, Promotional Compliance, Inspections, Regulations, Canada, Row, Emerging Markets |
| Intended For: | This course will be extremely valuable for those with 1 – 5 years of experience in regulatory affairs and those interested in understanding the regulatory road map for drugs and biologics development. This will include regulatory personnel, clinical/prin |
| Organization: | PERI |
This course will provide a comprehensive overview of US/FDA, European, Canadian, Japanese and Rest-of-World (ROW)/emerging market regulations for drugs and biologics development from pre-clinical to post approval. Emphasis will be on FDA, European, and Canadian regulatory similarities and differences. Interactive sessions and workshops will identify and address regulatory obstacles faced by regulatory affairs professionals.
Key Topics: • US Regulations: IND, NDA, post approval and other activities • EU Regulations: Clinical development, MAA, and post approval phases • Canadian & Japanese Regulations • Rest-of-World (ROW)/Key Emerging Market Regulations • Inspections • Adverse Events Reporting • International Conference on Harmonization (ICH) • Interaction with Regulatory Agencies: Dos and Don’ts • Promotional Compliance • Registration Regulations for Biologics • What’s New in Biogenerics, Biosimilars, Follow-on Biologics