Pharmacovigilance Aspects of Licensing Agreements Training Course

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

10 July 2024
+ 27-28 November 2024 »
from £549

Need help? Enrol or reserve

Format: Live online
CPD: 6 hours for your records
Certificate of completion

Download Print Enrol or reserve

Course overview

Whilst licensing agreements involving medicines are primarily driven by commercial factors, the successful handling of pharmacovigilance obligations is a critical, but frequently overlooked, consideration. Negotiating the safety arrangements to ensure regulatory compliance by both partners can be a complex process, which is further compounded by a lack of harmonisation and clarity of the regulations around the world.

This intensive one-day seminar will review the existing global requirements relating to pharmacovigilance in contractual agreements. The emphasis will be on practical advice as to how to remain compliant with the legal obligations and how to satisfy good pharmacovigilance practice and quality management requirements, as well as how to promote harmonious business partnerships.

A practical workshop session will help consolidate the information provided under the guidance of our expert trainers.

Benefits of attending

Make sense of the licensing agreement jungle
Ensure you stay compliant with global pharmacovigilance requirements
Understand what the regulators expect
Master the essentials of licensing agreements – safety and business considerations
Consider the legal status and role of pharmacovigilance licensing agreements
Discuss audit and compliance aspects of third-party agreements

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Who should attend

The programme will be of interest to all personnel 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.

Enrol or reserve

This course will cover:

Global regulatory framework

EU, USA and what ICH says
How it impacts partnerships
What the regulators expect
- From the pharmacovigilance system
- From the MAH
- From the MAH’s partners

Best pharmacovigilance practices in licensing agreements

Types of agreement
Safety Data Exchange Agreement
Who is responsible for what?
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
- Usingtemplates
Contractual liability and indemnities
Amendment and termination of pharmacovigilance agreements

Audit and compliance aspects of third-party agreements

Regulatory expectations and inspections
Which agreements to examine at audit
What to look for in safety data exchange agreements at pharmacovigilance audit
Which partners to audit and how
Measuring partner/other party compliance

Workshop – practical aspects of licensing agreement

Enrol or reserve

Joanne Flitcroft
Opallios

Joanne Flitcroft is a qualified solicitor with over 22 years’ experience. She trained in the City of London and later specialised in pharmacovigilance as part of a FTSE 100 pharmaceutical company’s global legal team. Joanne founded Opallios in 2016, a legal consultancy providing advice to companies operating in the life sciences sector. Her clients include pharmaceutical companies, CROs and health communications companies. Joanne is a Non-Executive Director on the Board of the British Society of Gastroenterology, a Governor on the Board of Edge Hill University and a school governor. She has travelled across West Africa in a Ford Fiesta and besides travel, enjoys spending her spare time pursuing her interest in the classics.

More details

Graeme Ladds
PharSafer Associates Ltd

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

10 July 2024

Live online

09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 13787

GBP 649
EUR 929
USD 1,049

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

27-28 November 2024

Live online

13:30-16:45 UK (London) (UTC+00)
14:30-17:45 Paris (UTC+01)
08:30-11:45 New York (UTC-05)
Course code 14003

GBP 549 649
EUR 789 929
USD 893 1,049

Until 23 Oct

2 sessions of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.