Some of the topics to be covered at this meeting include overview of the legal/policy landscape as it affects the terms of CTAs, clause by clause review, legal clauses, review of a Universitys CTA
The effective management of the pharmacovigilance aspects of commercial agreements is essential for all parties involved. Ensuring the inclusion of key pharmacovigilance-relevant terms in agreements and monitoring compliance with them can be challenging, but is essential for compliance with current regulatory requirements relating to medicinal products.
This interactive seminar will address the key regulatory requirements relating to pharmacovigilance and discuss how to ensure that they are taken into account in various types of commercial arrangements. The emphasis will be on identifying the key terms needed in different types of agreement with a view to ensuring regulatory compliance and on a practical approach to drafting.
The seminar will be of interest to personnel involved in negotiating, preparing and managing commercial agreements of various types (for example, between co-marketers and with distributors, vendors and service providers) where the inclusion of pharmacovigilance terms and obligations is needed, including those working in legal, safety, commercial, and regulatory affairs departments.
Types of commercial arrangement in the pharmaceutical industry
Contracts – the basics
Regulatory requirements and guidance on pharmacovigilance relevant to pharmaceutical commercial agreements
Key considerations in negotiating, drafting and managing agreements
Key pharmacovigilance terms for commercial agreements – overview
INTERACTIVE SESSION – Discussion and review of sample key clauses: co-marketing and distribution agreements
INTERACTIVE SESSION – Discussion and review of sample key clauses: co-promotion agreements, arrangements with vendors and service providers
Common problems, audit and inspection findings
This course qualifies for the following CPD programmes: