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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

★★★★★ "It was very enlightening. The speakers spoke very calmly and with good diction."

1 March 2024
+ 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

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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, which features other pharmacovigilance training courses for professionals.

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

The Pharmacovigilance Aspects of Licensing Agreements 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 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

1 March 2024

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 13531

GBP 549 649
EUR 789 929
USD 893 1,049

Until 26 Jan

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

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 549 649
EUR 789 929
USD 893 1,049

Until 05 Jun

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.

Reviews of IPI's Pharmacovigilance Aspects of Licensing Agreements training course

It was very enlightening. The speakers spoke very calmly and with good diction.

Nov 29 2023

Vivian Stefani Brazil
PV analyst, Eurofarma Laboratórios

Mar 17 2023

Very good webinar

Martin Smatana Slovak Republic
Senior Pharmacovigilance Manager, EWOPHARMA International s.r.o.

Oct 8 2021

Both speakers set out their presentations in a clear and easy-to-follow manner, ensuring that a wide range of points were covered. Both answered everyone's questions in great detail which was very helpful and the experience and expertise of each speaker was evident.

Michaela Muller Isle of Man
Safety Scientist, Panacea Pharma Projects Ltd

Oct 8 2021

Very good presentations and discussions. Overall good interactions of participants.

Mario Caiano Italy
PV Operations Unit Support - GVP Compliance Manager, PQE

Apr 15 2021

The course gave me a basis for some challenges in relation to obligations and negotiations related to the pharmacovigilance operation in the face of the growing number of partnerships that my company has been establishing. Very useful explanation! Very thoughtful speakers. They answered all questions and brought practical examples.

Gabriela Diniz Brazil
Pharmacovigilance Manager , Eurofarma

Apr 15 2021

Both presenters were so good and delivered a very clear message. After changing company I now have all I need to back up my experience with. Thank you both!

Said Alfredsson Denmark
PV Agreement Manager, Ferring IPC

Apr 15 2021

It was a very thorough explanation on the licensing aspects in PhV. It helped me understand the process better and to improve myself in the pharmacovigilance and regulatory fields.

Vlad Vorotneac Romania
Pharmacovigilance Agreement Associate, Teva Pharmaceuticals Romania

Apr 15 2021

Good quality of speakers, good content. I would recommend it to a colleague.

Maria Sampaio Portugal
Associate Pharmacovigilance and Drug Safety Manager, BIAL - Portela & Cª, S.A.

Oct 8 2019

Overall, it was a good course. The speakers and presentations were to the point, and the speakers had good knowledge and experience.

Ingvild Liborg United Kingdom
General Manager, Chemidex Pharma

Oct 8 2019

The course was very interesting and useful for our daily work in the future.

Ioana Vochin Romania
Pharmacovigilance Agreement Associate, Teva Pharmaceuticals Romania

Oct 8 2019

The course covered all aspects of managing PVAs. The presentation was clear and concise and speakers had a high degree of knowledge of the subject.

Alicia Rodriguez Spain
Pharmacovigilance Technician , PharmaMar

Oct 8 2019

The speakers are experienced and knowledgeable on the current regulations and did very well in their respective presentations.

Kennedy Cliff-Eribo United Kingdom
Assistant Pharmacovigilance MAnager, Glenmark Pharmaceuticals Europe R&D Ltd

Oct 2 2018

The course fulfilled my expectations...In general, I would and did recommend to other colleagues working with PV agreements.

Ivana Hezoucky Austria
Regional PV Manager, Boehringer Ingelheim

Feb 20 2018

The course was excellent. I thoroughly enjoyed it. The speakers were clearly very knowledgeable, and were able to answer any questions. The presentations were all very clear and concise, which makes any presentation more enjoyable.

Leah Baker United Kingdom
Pharmacovigilance Scientist, Norgine Ltd

Feb 20 2018

Well structured and insightful

Shirley-Ann van der Spuy United Kingdom
Managing Director & EU QPPV, Red Line Pharmacovigilance Ltd

Feb 20 2018

Excellent, to the point

Pankaj Nautiyal United Kingdom
‎Senior Pharmacovigilance Auditor, Glenmark Pharmaceuticals

Feb 20 2018

It was good

Sattam Alghodyyr Saudi Arabia
Pharmacovigilance Manager, SPIMACO