Stamford, CT, September 16, 2010 – Synowledge LLC, a market leader in drug safety and pharmacovigilance services and related IT solutions for life sciences organizations of all sizes announced today that Dr. Jacinta Aniagolu Johnson, Director, Pharmacovigilance and Risk Management, will be representing Synowledge at Pacific Drug Safety Summit at San Francisco Airport Marriott, Burlingame, California, USA on 23rd-24th September 2010.
The Pacific Drug Safety Summit will provide half-day training sessions on key drug safety and pharmacovigilance practice areas. Attendees will have the opportunity to participate in networking breaks and interact with a diverse gathering of US and EU drug safety and pharmacovigilance practitioners, service providers, and vendors.
Conference Details: Pacific Drug Safety Summit
Date & Time: September 23-24, 2010, 8.30 am – 5.00pm Pacific Time
Location: San Francisco Airport Marriott, Burlingame, California, USA
Pre-Conference Tutorial #2: Risk Evaluation and Mitigation Strategies (REMS)
An Overview of Current Regulations and Approach to Documentation and Preparation
Speaker: Dr. Jacinta Aniagolu Johnson, Director, EU PV and Risk Management
Description: A full agenda of contemporary, cutting-edge pharmacovigilance topics from nine experienced speakers in the pharmacovigilance and risk management field.
Dr. Jacinta, along with Mark Loudon from Aris Global, will present an overview of current regulations and approaches to documentation and preparation. The goal will be to provide users with information about practical mechanisms at both the strategic and operational level to help demystify and apply proper risk management methods.
Topics include:
- Practical Elements for Risk Management
- FDAAA
- Relationship between REMS and RiskMAPs
- FDA REMS template
- REMS contents
- Highlights of the FDA draft REMS Guidance, and examples of FDA-approved proposed REMS
About Dr. Jacinta Aniagolu Johnson
Dr. Jacinta Aniagolu is a trained biomedical and clinical research scientist, an AE/ADR signal analysis and pharmacovigilance, risk management and drug safety surveillance subject matter expert. She has 17 years combined expertise and cross-functional knowledge in biomedical and clinical drug development research, drug safety surveillance, pharmacovigilance, and risk management. Currently, as the Director, Pharmacovigilance and Risk Management, at Synowledge, Dr. Aniagolu directs client Pharmacovigilance and Risk Management project activities. She provides leadership, guidance and subject matter expertise in the areas of Drug Safety and Pharmacovigilance, and medical/scientific affairs.
About Synowledge
Synowledge is a global provider of drug safety and pharmacovigilance services and related IT solutions to small, mid and large size pharmaceutical and biotechnology companies. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all our clients’ needs. With more than 15 years of industry experience, our core team members have worked with leading pharmaceutical, biotech, medical device and health provider organizations. We have our headquarters located in Stamford CT, USA and additional offices in Bangalore, India and the United Kingdom. For more information, please visit www.synowledge.com.
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