Pharmacovigilance aspects of licensing agreements

Instructor: Dr.Sidney Kahn
Product ID: 700928
  • Duration: 60 Min

recorded version

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Last Recorded Date: Jul-2008

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Read Frequently Asked Questions

Regulatory expectations for reporting in multi-company development and marketing programs.

Agreements to develop and market products between and among companies have become increasingly common and more complex in recent years. In an ever more stringently regulated environment, ensuring that all parties to licensing agreements are fully aware of and compliant with global regulatory reporting requirements requires careful preparation of and assiduous attention to the construction of data exchange agreements and ongoing safety data exchange and evaluation.

Areas Covered in the seminar:

  • Regulatory expectations for reporting in multi-company development and marketing programs.
  • International standards for data exchange.
  • Practical aspects of compliance with standards and regulations.
  • Pitfalls and their avoidance.

Who will benefit:

Pharmaceutical, biologicals, and diagnostic company personnel responsible for:

  • Drug safety
  • Legal department
  • Regulatory affairs
  • Clinical research
  • Labeling
  • Independent providers of pharmacovigilance and risk management services to industry

Instructor Profile:

Dr. Sidney Kahn, (MB, ChB., Ph.D., FRCPath, MFPM) is President of Pharmacovigilance & Risk Management Inc. (, which he founded in 2002. After 17 years in academic medicine, he spent 13 years managing industry groups responsible for safety assessment of medicines throughout their lifecycle. He was actively involved in many global pharmacovigilance initiatives, representing PhRMA on several ICH EWGs, and participating in the CIOMS-VI WG and recent US labeling initiatives. He is a frequent speaker in the USA and Europe on all aspects of pharmacovigilance, risk management, and labeling and provides consultative services and training on all aspects of safety across the industry.

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