Understand RMPs relationship to safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance
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 include the latest updates.
Benefits of attending:
Please note that we are also running:
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
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, sales and marketing, legal, commercial and quality.
Introduction, welcome and objectives
An introduction to RMPs
Outline of EU RMPs
The EU templates and their completion – generic and innovator products
Completion of RMPs in other countries
The EU RMP and relationship with other documents
Overview of the sections of the EU RMP template
Overview of the sections of the EU RMP template (continued)
Final discussion session
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.
| 29 Jun 2020 | ||||
| 29 Jun 2020 | Rembrandt Hotel, London | GBP 699.00 EUR 979.00 USD 1,090.00 + VAT @ 20.00% |
GBP 599.00 EUR 839.00 USD 934.00 Until 29 May* |
Enrol now |
* Note the early booking discount cannot be combined with any other offers or promotional code
“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
“Overall, I'm satisfied with the course and i think the sequence of the course topics was very logical and organised although it was condensed.”
Rania Ali, Senior Safety Associate, Amgen
“Very knowledgable about [the] subject area. Good content and interesting presentation and speaker. ”
Harriet Gillespie, Senior Medical Writing Scientist, Janssen-Cilag Limited
“Very knowledgeable. Very well presented and in-depth description presented on each section. ”
Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International
“Good course, would recommend it to others as well. Speakers well prepared and the presentation was good. ”
Gabor Varbiro, Medical Adviser, Wockhardt UK Ltd
“I enjoyed Graemes real world examples. He addresses people with different knowledge abilities very well”
Alice King, Regulatory Affairs Associate, Creo Pharma Ltd
“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
“Good course, good topic. Practical details offered, experiences. The speaker is excellent with the topic and has great experience. ”
Jorge Ignacio Gonzalez Borroto, Pharmacovigilance Officer, Grupo Ferrer Internacional SA
“Fantastic”
Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies
“Very useful and engaging”
Lauren Tuitt, ProductLife
“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, EU QPPV, Redline Pharmacovigilance Ltd