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A Practical Guide to Writing Risk Management Plans (RMPS)

Price

£699*

Location

London, United Kingdom

Date

04 Jul 2018

Reference No: M1802263-MAF

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Event Description

Course Outline:

Topics to be covered will include:-

  • An Introduction to ICH & EU RMPs – Production & Maintenance
  • Documentation to be Supplied to Regulatory Authorities – the process for RMPs
  • The EU Templates & their Completion – Generic and Innovator Products
  • RMPs in other Countries
  • Practical – Completion of Sections I – III
  • Practical – Completion of Sections IV – VI
  • Practical – Completion of Annexes

When & Where?

When:
4 July 2018

Where:
Cavendish Hotel
London

*Cost?

 GBP 699
 EUR 979
 USD 1,090

GBP price excludes VAT @20%

The new Pharmacovigilance Legislation of 2012 now requires companies to provide Risk Management Plans (RMPs) and assessments for all new products whether those products are generic products or new chemical entities. If these are not done correctly this can delay both licensure and sales and damage the Company ability to maximise its products. Maintenance of the RMPs also is an important aspect for maintaining the licence, compliance and these are reviewed in Regulatory Inspections. Can you afford not to get this right?

 

Applicant Requirements
  • Anyone requiring a comprehensive overview of the Pharmacovigilance function and duties
  • Those who are responsible in Pharmacovigilance for any safety assessments and writing such plans
  • Any Medical Directors who approve such plans
  • Those who work with pharmacovigilance, e.g. Regulatory Affairs, Clinical, Sales & Marketing, Legal, Commercial and Quality and EU QP PVs that must sign off such documents
Reference No: M1802263-MAF
For over 30 years Management Forum has been an internationally renowned independent training company which organises professional conferences, seminars and in-house courses for the Life Science and Intellectual Property sectors.

Email info@management-forum.co.uk

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