Presented by
Management Forum
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
27-28 November 2024
+ 10 March 2025, 1 July 2025, 1-2 December 2025 »
from £549
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
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
Until 23 Oct
Not ready to book yet?
for 7 days, no obligation
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.
United Kingdom
Spain
Denmark
Germany
France
Switzerland
United States of America
Italy
Belgium
Netherlands
Finland
Ireland
Portugal
Romania
Austria
Brazil
Canada
Czech Republic
Slovak Republic
Croatia
Greece
Hungary
India
Isle of Man
Israel
Korea, Republic Of
Mexico
Norway
Poland
Russia
Saudi Arabia
Slovenia
United Arab Emirates
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: