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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

25 Apr 2022

& 13 Jul 2022 , 17 Oct 2022

Book now

Details

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

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.

Programme

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

Presenters

Joanne Flitcroft (More...)

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.

Graeme Ladds (More...)

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.

Book now

Book now

25 Apr 2022
Live webinar
25 Apr 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 21 Mar 22*
Enrol now
to attend
Live webinar
13 Jul 2022
Face-to-face, (venue not yet confirmed)
13 Jul 2022
Face-to-face
(venue not yet confirmed)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 8 Jun 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
17 Oct 2022
Live webinar
17 Oct 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 12 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Abbott Healthcare Products BV
  • Actavis UK Ltd
  • Actelion Pharmaceuticals Ltd.
  • Alcon Laboratories SA
  • Alfrapharma Srl
  • Arrow No.7 Limited
  • ASTRAZENECA GMBH
  • Bausch & Lomb Inc
  • Baxter Innovations GmbH
  • Chiesi Farmaceutici SPA
  • Glenmark Pharmaceuticals Europe R&D Ltd
  • H. Lundbeck A/S
  • Helsinn Healthcare SA
  • IDIS WORLD MEDICINES
  • Ingenix Pharmaceutical Services Spain S.L.
  • Institut De Recherches Internationales Servier
  • Merck KGaA
  • MorphoSys AG
  • Novartis Pharmaceuticals
  • Orion Oyj
  • Pharmatek Consultancy Services
  • Pharmathen Industrial SA
  • Procter & Gamble Technical Centres Ltd
  • Ranbaxy Laboratories Ltd
  • Red Line Pharmacovigilance Ltd
  • Research and Markets
  • Sandoz International GmbH
  • Valeant Pharmaceuticals Ltd
  • Waymade Plc
  • Wyeth Europa Ltd

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

Mario Caiano, PV Operations Unit Support - GVP Compliance Manager, PQE, Oct 21

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 21

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 21

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 21

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 21

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., Apr 21

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 19

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 19

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

Ioana Vochin, Pharmacovigilance Agreement Associate, Teva Pharmaceuticals Romania, Oct 19

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 19

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

Ivana Babiakova, Regional PV Manager, Boehringer Ingelheim , Oct 18

Christine was a good speaker regarding the legal aspects.

Smitha Bhat, Safety Data Exchange and Quality Scientist , GSK, Oct 18

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 18

It was good

Sattam Alghodyyr, Pharmacovigilance Manager, SPIMACO, Feb 18

Excellent, to the point

Pankaj Nautiyal, ‎Senior Pharmacovigilance Auditor, Glenmark Pharmaceuticals , Feb 18