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.
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
Course Provider
Dr.Sidney Kahn,
