Pharmacovigilance aspects of licensing agreements
Instructor:
Dr.Sidney Kahn
Product ID: 700928
- Duration: 60 Min
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
Dr. Sidney Kahn, (MB, ChB., Ph.D., FRCPath, MFPM) is President of Pharmacovigilance & Risk Management Inc. (www.pvrm.com), 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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
