Presented by
Management Forum
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
★★★★★ "Both speakers were very knowledgeable and approachable for any questions. The solutions provided wer... more (24)"
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.
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.
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.
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
10 March 2025
Live online
09:30-16:30 UK (London) (UTC+00)
10:30-17:30 Paris (UTC+01)
05:30-12:30 New York (UTC-04)
Course code 14534
Until 03 Feb
Not ready to book yet?
for 7 days, no obligation
1 July 2025
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 14818
Until 27 May
Not ready to book yet?
for 7 days, no obligation
1-2 December 2025
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 15099
Until 27 Oct
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.
Both speakers were very knowledgeable and approachable for any questions. The solutions provided were helpful on specific scenarios.
Jul 10 2024
Heena Murarji
Global PV Alliance Manager, OTSUKA PHARMACEUTICALS EUROPE LTD
Jul 10 2024
Excellent content and great detailed presentations.
Michele Power
Global Pharmacovigilance Alliance Manager, Otsuka
Nov 27 2024
The content, presentation and speaker were very interesting and clear. They will enable me to improve the management and content of the company's vigilance agreements.
Diarra Ndour
Innothera Corporate Services – Groupe Innothera
Mar 1 2024
It was a very good webinar and a great topic, as I have not seen this topic in webinars before.
Dorte Jensen
QPPV Deputy, 2care4 Generics ApS
Nov 29 2023
Excellent speakers, comprehensive explanation, clear understanding... Very much recommendable
Anežka Staňková
SDEA Manager, ZENTIVA
Nov 29 2023
It was very enlightening. The speakers spoke very calmly and with good diction.
Vivian Stefani
PV analyst, Eurofarma Laboratórios
Mar 17 2023
Very good webinar
Martin Smatana
Senior Pharmacovigilance Manager, EWOPHARMA International s.r.o.
Nov 29 2023
The speakers were both excellent.
Nuria Cabello
PV Manager and QPPV, Farmaprojects SAU
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
Safety Scientist, Panacea Pharma Projects Ltd
Oct 8 2021
Very good presentations and discussions. Overall good interactions of participants.
Mario Caiano
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
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
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
Pharmacovigilance Agreement Associate, Teva Pharmaceuticals Romania
Apr 15 2021
Good quality of speakers, good content. I would recommend it to a colleague.
Maria Sampaio
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
General Manager, Chemidex Pharma
Oct 8 2019
The course was very interesting and useful for our daily work in the future.
Ioana Vochin
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
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
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
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
Pharmacovigilance Scientist, Norgine Ltd
Feb 20 2018
Well structured and insightful
Shirley-Ann van der Spuy
Managing Director & EU QPPV, Red Line Pharmacovigilance Ltd
Feb 20 2018
Excellent, to the point
Pankaj Nautiyal
Senior Pharmacovigilance Auditor, Glenmark Pharmaceuticals
Feb 20 2018
It was good
Sattam Alghodyyr
Pharmacovigilance Manager, SPIMACO
Oct 2 2018
Christine was a good speaker regarding the legal aspects.
Smitha Bhat
Safety Data Exchange and Quality Scientist , GSK
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2 days
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: