Reclassification: the early stages

Details

Where is it?

This workshop will be held at PAGB’s office at New Penderel House, 283-288 High Holborn, London, WC1V 7HP. Joining instructions will be sent to you before the course.

How much does it cost?

PAGB members and associate members: £300 + VAT @ 20%
Non-members: £775 + VAT @ 20%

For further information about PAGB’s workshops, please contact events@pagb.co.uk or call 020 7242 8331.

Join us for a face-to-face workshop where we will explain how to navigate the early stages of evaluating a POM to P switch candidate.

This workshop will complement our guidance document: How to identify a reclassification candidate and prepare for the early stages of the reclassification procedure.

This workshop will cover:

  • The factors that you need to consider when looking to make a switch
  • the potential generation of a product profile to support early discussions and meetings with MHRA
  • The type of risk minimisation measures that may be required to support a UK-based switch

Who should attend?

Regulatory colleagues and individuals within companies who are looking at potential POM to P reclassifications.

A maximum of 18 spaces are available for each workshop, which we are giving members the exclusive opportunity to book first.

Format

This short course will run between 10am and 2.30pm approx. (with a half hour break for lunch). The workshop is delivered by PAGB’s Chief Executive, Michelle Riddalls, and members of the PAGB regulatory team. You’ll receive copies of the presentations, practical examples and other useful materials to take away, and we’ll send you a certificate of attendance after the event.

Dates for 2024

The following sessions will take place in-person:

  • Thursday 8 February, 10:00-14:30
  • Wednesday 30 October, 10:00-14:30

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