Global Compliance Panel, MUMBAI,INDIA
This training course is designed to give pharmaceutical and biologic companies operating in the U.S.
EU an understanding of product safety and regulatory compliance.The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.
Product safety makes headlines every day - and the impact on a company’s image, consumer confidence, and Wall Street’s opinion is profound. While good safety data has historically been a prerequisite for product approval, recent media attention has intensified public and Congressional scrutiny and resulted in regulations such as the FDA Amendment Act and its strengthened requirements for monitoring post-marketing safety.
Agenda:
This training course is designed to give pharmaceutical and biologic companies operating in the U.S.
EU an understanding of product safety and regulatory compliance.The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.
Product safety makes headlines every day - and the impact on a company’s image, consumer confidence, and Wall Street’s opinion is profound. While good safety data has historically been a prerequisite for product approval, recent media attention has intensified public and Congressional scrutiny and resulted in regulations such as the FDA Amendment Act and its strengthened requirements for monitoring post-marketing safety.
Agenda:
- Overview of Pharmacovigilance
- Assessing Adverse Event Cases
- Reporting Adverse Events
- Global Regulatory Requirements
- Inspections and Audits
- Pharmacovigilance Best Practices
- Preparing for an Inspection
- Case Studies with Real-Life Inspection Findings
- Background to Signal Detection
- Signaling Exercises
- Data Mining Exercises
- Pharmacovigilance and Risk Management Process
Who will benefit:
- Drug safety and Pharmacovigilance
- Regulatory affairs
- Clinical development
- Executives (including C-Level) with any Legal responsibility for drug safety
- Clinical safety staff
- Pharmacovigilance specialists
- Regulatory affairs professionals
- Quality management specialists
- Management involved in clinical oversight
- Pharmacovigilance
- Pharmacoepidemiology
- Regulatory affairs
DATE AND VENUE:
March 5th, 6th and 7th, 2012
at Mumbai, INDIA
Conference Timings: 9:00 am - 6:00 pm
For more details: http://hum-molgen.org/meetings/meetings/5118.html
