Survival Strategies for Successful Pharmacovigilance InspectionsPrepare, Participate ... and Successfully Close!

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1 - 9999
1 - 9999
1 - 9999
Get ready ... get set ... the “ADE detectives” are coming. Haven’t gotten the call yet? You will. Pharmacovigilance field investigators are fanning out to drugmakers under the FDA’s purview.

FDA has new money budgeted for these crackdowns, known officially as the “Postmarket Adverse Drug Experience Inspectional Program.” And it’s not just U.S. companies facing the pharmacovigilance cops. Health Canada, for instance, is reported to be tacking pharmacovigilance inspections on the end of traditional GMP inspections.

In a fast-paced 90-minute Encore presentation, you and your staff will glean essential guidance on preparing in advance for pharmacovigilance inspections ... how to manage the investigation itself ... and most importantly, how to bring the matter to a close with no nasty aftershocks — such as 483s, warning letters ... even seeing clinical trials suspended and drugs pulled from market when violations are serious enough.

Pharmacovigilance investigators are likely to shine the spotlight without warning on staff who’ve never dealt with inspections too. Make sure your “newbies” are on hand for tips, advice and guidance on how to deal with these inspections. It could save your organization time, hassles — and actual dollars.

You and your entire staff will get the answers you need to pressing questions such as:

  • How do you determine whether the information you’re giving investigators is too little ... or too much?
  • How do you tailor SOPs specific to pharmacovigilance departments to pass inspections with flying colors?
  • How do pharmacovigilance inspections differ in the U.S., Canada and Europe?

You’ll discover:

  • 10 tips for conducting internal audits
  • 3 top corrective actions that follow pharmacovigilance inspections
  • 6 deficiencies that turn up most often during inspections
  • 7 criteria the FDA uses when deciding which firms to inspect first
  • And much more!

Improper risk management and drug safety can result in financial losses, substantial penalties, legal fees and worse. It can bring product approvals to a screeching halt. Add in the potential bad press and loss of reputation, and the risk simply becomes too great. Make sure your key staff — both new and experienced —  are on hand for this timely presentation. It’s ideal for:

  • Executive management
  • Regulatory affairs
  • Medical affairs
  • Research & development
  • Quality management

Barbro Westin, M.Sc. Ph.M., is Director, Pharmacovigilance at CanReg, Inc. Barbro has more than twenty years experience in the pharmaceutical industry with extensive knowledge of reporting regulations for adverse events in the United States, Canada and Europe with a focus on medical information and drug safety surveillance. She prepares clients, ranging from small biotechnical to large pharmaceutical companies, for inspections by health authorities ensuring compliance with appropriate regulations for pharmacovigilance commitments.

Irma Monaco, B.Sc., PT, is Associate Director, Medical Information at CanReg, Inc. Irma has more than 10 years of experience working with clients on issues with pharmacovigilance and medical information. She develops SOPs and ensures the compliance of clients with appropriate regulations for client’s pharmacovigilance commitments. She is a frequent trainer at many industry events.

Register now!

Date: July 6–24, 2009
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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