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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

10-11 December
+ 30 June 27, 8 December 27 »
from £649

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Course overview

Licensing agreements for medicines may be commercially driven, but overlooking pharmacovigilance obligations can create significant regulatory risk. Ensuring both partners meet their safety responsibilities requires careful negotiation, particularly in a global landscape where regulations often lack harmonisation and clarity. Getting these arrangements right is not just a legal necessity, it is essential for protecting patients and sustaining successful collaborations.

This intensive one-day course offers a focused exploration of global pharmacovigilance requirements within contractual agreements. It brings the subject to life with practical insights on maintaining compliance with legal obligations, meeting good pharmacovigilance practice and quality management standards, and building strong, cooperative partnerships between organisations.

To reinforce learning, the workshop session allows delegates to apply key concepts in a guided, practical setting, supported by expert trainer, Graeme Ladds, who bring real-world experience to the discussion. By the end of the course, delegates will be better equipped to navigate the complexities of pharmacovigilance in licensing agreements with confidence and clarity.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Navigate the complexity of licensing agreements with greater clarity
Stay compliant with global pharmacovigilance requirements
Understand exactly what regulators expect
Grasp the essentials of licensing agreements, including safety and business considerations
Explore the legal status and role of pharmacovigilance licensing agreements
Examine audit and compliance challenges in third-party agreements

Who should attend

This course is designed for professionals involved in business development and licensing agreements, including:

Drug safety and pharmacovigilance specialists
Regulatory affairs and drug registration professional
Medical directors
R&D directors
Company lawyers

Popular with...

This course has proven particularly popular among our customers in these roles:

Drug Safety Manager
Drug Safety Officer
Drug Safety Specialist
Manager
Pharmacovigilance Agreement Associate
Pharmacovigilance Manager
Pharmacovigilance Officer
Pharmacovigilance Specialist
Secretary
Senior Drug Safety Officer

Enrol/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
- Using templates
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
SDEAs and the PSMF

Workshop – practical aspects of licensing agreement

Enrol/reserve

Joanne Flitcroft
Opallios Limited

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 in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.

Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug–device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.

More details

Discounts for multiple bookings - bring your colleagues to make your training budget go further:

2nd delegate: 30% off
3rd delegate: 40% off - or FREE for advance bookings (12 weeks or more)
4th delegate: 50% off
5+ delegates: contact us for group or bespoke bookings

10-11 December

Live online

13:30-16:30 UK (London) (UTC+00)
14:30-17:30 Paris (UTC+01)
08:30-11:30 New York (UTC-05)
Timings may be different for each day
Course code 16584

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

3rd place FREE until 17 Sep

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

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Not ready to book yet?

for 7 days, no obligation

30 June 27

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 17263

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

3rd place FREE until 07 Apr

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

8 December 27

Live online

09:30-16:30 UK (London) (UTC+00)
10:30-17:30 Paris (UTC+01)
04:30-11:30 New York (UTC-05)
Course code 17671

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

3rd place FREE until 15 Sep

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

* 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.