Dublin, Nov. 20, 2023 (GLOBE NEWSWIRE) -- The "Pharmacovigilance Aspects of Licensing Agreements Training Course" has been added to ResearchAndMarkets.com's offering.
In the fast-paced world of pharmaceutical licensing agreements, where commercial considerations often take the lead, the importance of pharmacovigilance obligations can't be underestimated. Regulatory compliance, safety, and harmonious business partnerships are at stake, making it imperative to master the intricacies of this critical aspect.
The "Pharmacovigilance Aspects of Licensing Agreements Training Course," is an intensive one-day seminar designed to provide you with a comprehensive understanding of global pharmacovigilance requirements within contractual agreements. This seminar emphasizes practical advice on maintaining compliance with legal obligations, adhering to good pharmacovigilance practices, and ensuring the quality management required for seamless business collaborations.
Benefits of Attending:
- Make sense of the licensing agreement jungle: Gain insights to navigate complex licensing agreements effectively.
- Stay compliant with global pharmacovigilance requirements: Understand the global regulatory framework impacting partnerships.
- Master the essentials of licensing agreements: Explore safety and business considerations vital for success.
- Consider the legal status and role of pharmacovigilance licensing agreements: Delve into the legal aspects of these agreements.
- Discuss audit and compliance aspects of third-party agreements: Learn about regulatory expectations and inspections.
Certification:
- CPD: Earn 6 hours for your professional development records.
- Certificate of Completion: Receive a certificate upon course completion.
Who Should Attend?:
This program is tailored for professionals involved in business development and licensing agreements, including those working in drug safety and pharmacovigilance, regulatory affairs and drug registration, medical directors, R&D directors, and company lawyers.
Agenda:
Global Regulatory Framework:
- EU, USA, and what ICH says
- Impact on partnerships
- Regulators' expectations
- Insights from the pharmacovigilance system
- Expectations from the MAH
- Expectations from the MAH's partners
Best Pharmacovigilance Practices in Licensing Agreements:
- Types of agreement
- Safety Data Exchange Agreement
- Responsibilities of each party
- Joint handling of pharmacovigilance issues
Legal Aspects:
- The legal status and role of pharmacovigilance agreements
- Drafting pharmacovigilance agreements
- Contract basics, dos, and don'ts
- Terminology, form, and content
- Using templates
- Contractual liability and indemnities
- Amendment and termination of pharmacovigilance agreements
Audit and Compliance Aspects of Third-Party Agreements:
- Regulatory expectations and inspections
- Identifying agreements for audit
- Key considerations for safety data exchange agreements during pharmacovigilance audits
- Selecting partners for audit and audit methodologies
- Measuring partner/other party compliance
Workshop - Practical Aspects of Licensing Agreements:
Speakers:
- Graeme Ladds, Director, PharSafer Associates Ltd.: Graeme Ladds brings over 22 years of pharmaceutical industry experience to the table. His expertise includes pharmacovigilance establishment, audits across Europe and the USA, SOP development, acting as QP for companies, and assisting with regulatory inspections.
- Joanne Flitcroft, Opallios: Joanne Flitcroft is a qualified solicitor with more than two decades of experience. She specializes in pharmacovigilance and founded Opallios, a legal consultancy for the life sciences sector. Her clients include pharmaceutical companies, CROs, and health communications companies.
Join us for this exclusive training course and gain valuable insights into the pharmacovigilance aspects of licensing agreements. Register today to stay compliant, enhance your expertise, and foster successful collaborations in the pharmaceutical industry.
For more information about this conference visit https://www.researchandmarkets.com/r/zfomvr
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