USFDA & EU Essentials of Drug Safety and Pharmacovigilance – India Seminar 2012 at Mumbai

Description

Overview: This training course is designed to give pharmaceutical and biologic companies operating in the U.S. and 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

Steve Jolley, Principal, SJ Pharma Consulting

Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA. He has 25 Years’ experience in drug safety & Pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide.

 

DATE AND VENUE:

March 5th, 6th and 7th, 2012

at Mumbai, INDIA

Conference Timings: 9:00 am - 6:00 pm 

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