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A Practical Guide to Writing Risk Management Plans (RMPs) Training Course
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Details
Course overview
In the EU, all companies are required to provide risk management plans (RMPs) for every new product, whether generic products or new chemical entities, and these RMPs must also be modified and updated throughout the lifetime of a medicine. This intensive one-day course will provide you with an invaluable overview of writing and maintaining RMPs, with practical advice to ensure you achieve regulatory compliance. You will discuss best practice for using the EU templates and risk minimisation tools to enhance the benefit/risk of your product.
The programme has been fully revised to cover the latest updates and new requirements, including amendments made to the previous template.
Benefits of attending:
- Gain an overview of ICH and EU RMPs – their production and ongoing maintenance
- Clarify the documentation to be supplied to regulators and the process for RMPs
- Learn what happened in the EU RMP update and explore the new requirements
- Discuss the EU templates and their completion – generic and innovator products
- Understand the relationship between RMPs, post-authorisation safety and efficacy studies, safety reviews and PBRERs
- Discuss the RMP and risk minimisation follow-up
Please note that we are also running:
Book together and save
This meeting runs back-to-back with Producing and Maintaining the Pharmacovigilance System Master File (PSMF). Save an additional £100/€140 if you book both together.
To find out more please call customer services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk
Who should attend?
This course will be relevant for those working in pharmacovigilance who are involved with writing RMPs, including medical directors/QPPVs who approve such plans. It will also be of interest to those who work with pharmacovigilance, eg in regulatory affairs, clinical, pre-clinical, sales and marketing, legal, commercial and quality.
Programme
Introduction, welcome and objectives
An introduction to RMPs
- Outline and purpose of ICH E2E
- The implementation of ICH E2E
- National adoption of ICH E2E
- Europe
- USA
- Japan
- Arab States
Outline of EU RMPs
- The current EU module V requirements
- Generic, innovator and advanced therapy products
- Additional documents to supply to the regulators
- Safety reporting timelines for RMPs
- EU RMP update and new requirements
The EU templates and their completion – generic and innovator products
- The EU generic template – EU requirements (module V)
- The EU generic RMP versus innovator RMP
- The EU template for innovator products
Completion of RMPs in other countries
The EU RMP and relationship with other documents
- The RMP post-authorisation safety and efficacy studies
- The RMP and PBRERs
- The RMP and safety reviews
Overview of the sections of the EU RMP template
- Part I – Product overview
- Part II – Safety specification modules SI-SVIII
- Part III – Pharmacovigilance plan including safety studies
- Part IV – Plans for post-authorisation efficacy studies
- Part V – Risk minimisation activities including effectiveness measures
- Part VI – Summary of the risk management plan
- Part VII – Annexes
Final discussion session
Presenter
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.
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Book now
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28 Jan 2021 Live webinar |
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28 Jan 2021 Live webinar |
GBP 499.00 EUR 719.00 USD 814.00 Until 17 Dec* |
Enrol now
to attend Live webinar |
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4 Feb 2021 Face-to-face, (venue not yet confirmed) |
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4 Feb 2021 Face-to-face (venue not yet confirmed) |
GBP 599.00 EUR 839.00 USD 934.00 Until 24 Dec* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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|
28 Jun 2021 Live webinar |
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|
28 Jun 2021 Live webinar |
GBP 499.00 EUR 719.00 USD 814.00 Until 17 May 21* |
Enrol now
to attend Live webinar |
|
|
30 Jun 2021 Face-to-face, (venue not yet confirmed) |
|||
|
30 Jun 2021 Face-to-face (venue not yet confirmed) |
GBP 599.00 EUR 839.00 USD 934.00 Until 19 May 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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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
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.
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Previous customers include...
- Alander Consulting Limited
- Alfrapharma Srl
- Almac Group
- Amgen
- Blue Reg Pharma Consult
- Colgate-Palmolive R&D
- Creo Pharma Ltd
- ELPEN Pharmaceutical Co Inc
- Emtex BVBA
- Ewopharma International s.r.o
- FAES FARMA SA
- Ferrer Internacional, S.A.
- Fresenius Kabi Ltd & Calea UK Ltd
- Icon Clinical Research (UK) Limited
- Iggea Ltd
- IRE-TEX INNOVATIONS LTD
- Janssen Pharmaceutica NV
- Janssen-Cilag Limited
- Jenson R+ Ltd
- LINK Medical ApS
- Medac GmbH
- Mediplex Ltd
- NDA Regulatory Science Ltd
- Norgine Ltd.
- Pharmacovigilance Matters Limited
- ProductLife
- PTC Therapeutics
- Recordati
- Sanquin Plasma Products
- VAN Pharma Consult
“I found the course worthwhile. The presenter was easy to follow and gave practical examples which I found useful.”
Laura Maginley, Manager, EU Regulatory Sciences, Biogen, Jan 20
“Graeme was an extremely knowledgeable source who focused on imparting the most important information for us to understand the RMP writing process. I was looking to gain a better understanding of preparing RMPs in accordance with legislation and I believe that Graeme did an excellent job in providing this.”
Rex Alexander, Pharmacovigilance Compliance Manager - EUPV, APL Swift Services (Malta) Ltd, Jan 20
“Very good course that gave an overall understanding of the RMP and its purpose, presented by a very good communicator with many years of experience.”
Tina Maria Greve, Drug Safety Advisor, ALK-Abello A/S, Jan 20
“The course was fast paced, but if we had questions Graeme went back over and clarified, which I appreciated as I didn't share the same background as most of the other course candidates. I walk away with a clear understanding of the guidance behind and purpose of Risk Management Plans. ”
Jennifer Hynes, Quality Manager, Benchmark Vaccines Limited, Jan 19
“Overall, I'm satisfied with the course and think the sequence of the course topics was very logical and organised. ”
Rania Ali, Senior Safety Associate, Amgen, Jan 19
“Very knowledgable about [the] subject area. Good content and interesting presentation and speaker. ”
Harriet Gillespie, Senior Medical Writing Scientist, Janssen-Cilag Limited, Jul 18
“Very knowledgeable. Very well presented and in-depth description presented on each section. ”
Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International, Jul 18
“Overall a well organized course providing relevant knowledge about preparing RMPs. The presentation was good and the presenter has a substantial experience in the field of PV.”
Gabor Varbiro, Medical Adviser, Wockhardt UK Ltd, Jan 18
“I enjoyed Graeme's real-world examples. He addresses people with different knowledge abilities very well.”
Alice King, Regulatory Affairs Associate, Creo Pharma Ltd, Jan 18
“Good course, would recommend it to others as well. Speakers well prepared and the presentation was good. ”
Gabor Varbiro, Medical Adviser, Wockhardt UK Ltd, Jan 18
“Very useful and engaging.”
Lauren Tuitt, ProductLife, Jul 16
“Good course, good topic. The speaker is excellent and has great experience. ”
Jorge Ignacio Gonzalez Borroto, Pharmacovigilance Officer, Grupo Ferrer Internacional SA , Jul 16
“I have always found Management Forum courses to be of a high standard. They are my preferred teaching and training source for staff at Redline PV.”
Shirley-Ann van der Spuy, Managing Director & EU QPPV, Red Line Pharmacovigilance Ltd, Jul 16
“Fantastic!”
Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies, Jul 16