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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
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
The RMP and Risk Minimisation Follow up
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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13 Jan 2022 Live webinar |
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13 Jan 2022 Live webinar |
GBP 599 499 EUR 859 719 USD 970 814 Until 9 Dec* |
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to attend Live webinar |
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4 Apr 2022 Face-to-face, (venue not yet confirmed) |
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4 Apr 2022 Face-to-face (venue not yet confirmed) |
GBP 699 599 EUR 979 839 USD 1,090 934 Until 28 Feb 22* |
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11 Jul 2022 Live webinar |
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11 Jul 2022 Live webinar |
GBP 599 499 EUR 859 719 USD 970 814 Until 6 Jun 22* |
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to attend Live webinar |
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3 Oct 2022 Face-to-face, (venue not yet confirmed) |
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3 Oct 2022 Face-to-face (venue not yet confirmed) |
GBP 699 599 EUR 979 839 USD 1,090 934 Until 29 Aug 22* |
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to attend Face-to-face (venue not yet confirmed) |
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