Presented by
Management Forum

Pharmacovigilance Aspects of Licensing Agreements

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

25 Apr 2022 + 2 more dates

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  • Format: Live online, Classroom
  • CPD: 6 hours for your records
  • Certificate of completion

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.

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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

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Joanne Flitcroft

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.

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Graeme Ladds

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

Book Pharmacovigilance Aspects of Licensing Agreements Live online/Classroom training

25 Apr 2022

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 11615

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 21 Mar

In your basket 

13 Jul 2022

Classroom
London venue TBC

09:30-16:30 UK (London)
Course code 11404

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 08 Jun

  • 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

In your basket 

17 Oct 2022

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 11724

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 12 Sep

In your basket 

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


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.

Oct 8 2021

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 Babiakova
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

UK

  • Torbay Pharmaceuticals
  • Abbott Laboratories Ltd
  • Actavis UK Ltd
  • Allergan UK Limited
  • Almus Pharmaceuticals Ltd
  • Archimedes Pharma UK Limited
  • Arrow No.7 Limited
  • ARROW THERAPEUTICS LTD
  • Astellas Pharma Europe Ltd
  • AstraZeneca R&D Charnwood
  • AstraZeneca UK Ltd
  • Aurobindo Pharma Ltd
  • AXESS Limited
  • Bayer Healthcare
  • Bayer plc
  • Bionical Emas
  • Bristol-Myers Squibb
  • Britannia Pharmaceuticals Ltd
  • Celgene Europe Ltd
  • Cephalon Ltd
  • Chemidex Pharma
  • Chugai Pharma Europe Ltd
  • CSL Behring UK Ltd
  • DR REDDYS LABORATORIES (UK) LTD
  • Eli Lilly & Co Ltd
  • Ferring
  • Ferring Controlled Therapeutics (Scotland) Ltd
  • Ferring Pharmaceuticals Ltd
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • GlaxoSmithKline Services Unlimited
  • Glenmark Pharmaceuticals
  • Glenmark Pharmaceuticals Europe Limited
  • Glenmark Pharmaceuticals Europe R&D Ltd
  • GSK
  • GW Pharmaceuticals
  • Harefield Pharmacovigilance Ltd
  • Hospira UK Limited
  • IDIS WORLD MEDICINES
  • Janssen Cilag Ltd
  • Jazz Pharma
  • Merck Serono Ltd
  • Mercury Pharmaceuticals Ltd
  • MILLENNIUM PHARMACEUTICALS LTD
  • Mitsubishi Pharma Europe Ltd
  • Mundipharma Research Ltd
  • Mylan
  • Napp Pharmaceutical Group Ltd
  • Norgine Ltd
  • Novartis Pharmaceuticals UK Ltd
  • Panacea Pharma Projects Limited
  • Parexel International Ltd
  • Pfizer Limited
  • PHARMACO50
  • Pharmatek Consultancy Services
  • Procter & Gamble
  • Procter & Gamble Technical Centres Ltd
  • Ranbaxy Laboratories Ltd
  • Red Line Pharmacovigilance
  • Red Line Pharmacovigilance Ltd
  • Roche Products Ltd
  • Rosemont Pharmaceuticals
  • Rosemont Pharmaceuticals Limited
  • Sandoz Limited
  • SCHERING HEALTH CARE LTD
  • SEQ Limited
  • Shire Pharmaceutical Ltd
  • Stiefel Labs (UK) Limited
  • Summers Quality Assurance Ltd
  • Takeda Development Centre Europe Ltd
  • Teva UK Ltd
  • The Boots Company
  • Valeant Pharmaceuticals Ltd
  • Veterinary Medicines Directorate
  • Waymade Plc
  • Wyeth Europa Ltd
  • Wyeth Pharmaceuticals

Spain

  • Alcon Laboratories SA
  • Almirall S.A.
  • Atlanta Agencia de Viajes S.A.
  • Faes Farma S.A.
  • Fresenius Kabi España, S.A.U
  • FRESENIUS KABI ESPAÑA, SAU
  • Grifols S.A
  • Grupo Ferrer Internacional SA
  • Grupo Ferrer Internaional S.A.
  • Ingenix Pharmaceutical Services Spain S.L.
  • Instituto Grifols SA
  • Laboratorios Leti SL Unipersonal
  • Laboratorios Salvat SA
  • P & G Pharmaceuticals Iberia, S.L.
  • PharmaMar
  • ZAMBON, S.A.U.

France

  • AFSSAPS
  • ALEXION Europe SAS
  • I R I S
  • IQVIA
  • Merial SAS
  • Orphan Europe
  • Pierre Fabre Medicament
  • Recordati Rare Diseases Sarl
  • Sanofi Pasteur
  • Sanofi-Aventis R&D
  • Science Union SA
  • Stallergenes SAS
  • Teva Sante

Germany

  • ASTRAZENECA GMBH
  • AWD Pharma GmbH & Co KG
  • Bayer Pharma AG
  • Bayer Schering Pharma AG
  • Boehringer Ingelheim International GmbH
  • CHEPLAPHARM Arzneimittel GmbH
  • Grunenthal GmbH
  • Ingenix Pharmaceutical GmbH
  • Merck KGaA
  • Merck KGaA/Merck Serono
  • PHARMALEX GMBH
  • Sandoz International GmbH
  • Schwarz BioSciences GmbH

Switzerland

  • Actelion Pharmaceutical Ltd
  • Actelion Pharmaceuticals Ltd.
  • CILAG AG INTERNATIONAL
  • F. Hoffman-La Roche AG
  • F. Hoffman-La Roche Ltd
  • F. Hoffmann-La Roche Ltd
  • Ginsana SA
  • Helsinn Healthcare S.A.
  • Novartis International AG
  • NOVARTIS PHARMA AG
  • Tillotts Pharma AG
  • Vifor SA

Denmark

  • Actavis A/S
  • Actavis Group
  • Ferring IPC
  • Ferring Pharmaceuticals A/S
  • H. Lundbeck A/S
  • LEO Pharma A/S
  • PharmaChem Consulting
  • Pharmacosmos A/S
  • Takeda Pharma A/S
  • Xellia Pharmaceuticals AsP

United States of America

  • Bausch & Lomb Inc
  • FOREST LABORATORIES INC
  • GE
  • Novartis Pharmaceuticals
  • Pfizer
  • Vertex Pharmaceuticals, Inc

Belgium

  • Glaxo Smithkline Biologicals
  • GlaxoSmithKline Vaccines
  • Janssen Pharmaceutica NV
  • Pharm-AD
  • UCB Pharma SA

Italy

  • Alfrapharma Srl
  • Chiesi Farmaceutici SPA
  • DOC Generici S.r.l.
  • PQE

Finland

  • Orion Corporation
  • Orion Corporation Orion Pharma
  • Orion Oyj

Ireland

  • Horizon Therapeutics
  • Noden Pharma DAC
  • Pfizer Limited

Netherlands

  • Abbott Healthcare Products BV
  • APOTEX EUROPE
  • Astellas BV

Austria

  • Baxter Innovations GmbH
  • Boehringer Ingelheim

Canada

  • ApoPharma Inc
  • Sierra Oncology

Romania

  • Actavis Romania
  • Teva Pharmaceuticals Romania

Brazil

  • Eurofarma

Croatia

  • Pliva Hrvatska d.o.o.

Czech Republic

  • Zentiva Group AS

Greece

  • Pharmathen Industrial SA

Hungary

  • Gedeon Richter Lrd

Isle of Man

  • Panacea Pharma Projects Ltd

Israel

  • Teva Pharmaceuticals Industries Ltd

Korea, Republic Of

  • MedPacto

Norway

  • Pronova BioPharma Norge AS

Portugal

  • BIAL - Portela & Cª, S.A.

Russia

  • Pharm-Sintez CJSC

Saudi Arabia

  • SPIMACO

United Arab Emirates

  • GlaxoSmithKline

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy