American Conference Institute’s

Drug Safety, Pharmacovigilance and Risk Management Forum

Managing product risks and complying with FDAAA safety regulations

Monday, October 22 to Wednesday, October 24, 2012
The Union League, Philadelphia, PA

Learn to comply with new regulations without compromising the commercial viability of products

ACI’s Drug Safety, Pharmacovigilance and Risk Management Forum has been designed to provide you with a comprehensive understanding of safety regulations which will allow your company to successfully develop and implement a pharmacovigilance plan. Since the enactment of FDAAA, the FDA has identified over 100 products that require a REMS, and it is becoming almost inevitable that at some point a manufacturer will have to develop collateral safety material in order to obtain FDA approval. In light of this evolving regulatory landscape, it is increasingly important for drug and biologics manufacturers to understand the new safety obligations that can be mandated by the FDA.

Prepare your company for a drug safety assessment

While some safety mandates fall into the category of medication guides, others are more restrictive and impose burdensome obligations on manufacturers which have the potential to affect the profitability of a product. Beyond simply learning what the FDA expects of the manufacturers, this conference also focuses on the strategies manufacturers can employ to prevent a REMS or other safety requirement from negatively impacting a product in order to maximize profit.

Our faculty of in-house executives and outside counsel will provide you with the practical, real-world solutions you need to manage product risks in today’s regulatory environment. Hearing from manufacturers who have already gone through this process or who are in the midst of the process themselves, will provide you with the examples you need to find solutions to your company’s challenges.

Pre and Post-conference workshops enhance your conference learning

At the Pre-Conference Fundamentals of FDA Regulatory Law, participants can gain a primer on FDA regulatory matters that will provide a basic overview of FDA regulations and prepare you for the more in-depth discussions that will take place throughout the conference.

As manufacturing outsourcing becomes more of the norm for pharmaceutical companies, it is increasingly necessary to develop the skills to negotiate deals in foreign countries. At the Post-Conference Master Class on Pharmaceutical Manufacturing Outsourcing Agreements, workshop leaders will teach you how to minimize risk when conducting all or part of your manufacturing abroad.

Ensure your place in the conversation by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or registering online.