NEW Review Skills - Updated for 2020

Our 2020 public workshop programme is designed to drive the standards of review much higher, much earlier in the chain of material assessment thus reducing signatory pressure and accelerating project progression.

The programme consists of 3 modules, plus 4 one-to-one telephone coaching sessions.  Please add item to basket and e-mail enquiries@compliance-hub.com with your module date preferences.

Objectives

 

Reviewing materials and activities for Code compliance requires a thorough knowledge of the relevant aspects of the Code to enable the Reviewer to ask the right questions. It also requires the ability to understand, deconstruct and validate promotional claims. 

 

This workshop will expose delegates to a wide range of materials and activities including promotional materials, meetings and press releases. Delegates will learn what questions to ask and what substantiating evidence is required for each subject. There is a particular focus on Clause 7 to ensure a thorough understanding of how statements can slip into the trap of becoming misleading.

Suitable for

 People new to reviewing materials for approval; technical specialists, medical information

Other Development Ideas

 Please contact us to discuss:

Mock based scenario validation

Additional coaching support

 

How to book

Simply add one date for each module to your basket and checkout.  You will be asked if you wish to pay by credit card, or whether you wish to pay by purchase order.

Once your dates are booked, we will be in touch to organise your telephone coaching.

Module 1 - Promotional materials & claim substantiation

  • Considerations for hard copy & digital materials

  • Considerations for different material types

  • Mandatory information on different material types

  • Claim structure and substantiation in the context of promotional material

  • Clinical paper review to identify valid substantiation

  • Practical opportunities to review promotional material

Module 2 - Non-promotional materials

  • Considerations for hard copy and digital material

  • Considerations for different material types

  • Mandatory information on different material types (including material for patients/public/HCPs)

  • Identifying and amending inappropriate claims and writing styles

  • Practical opportunities to review non promotional material

  • Includes patient facing materials, press releases, market research 

Module 3 - Meetings and materials

  • Includes considerations for live and online meetings

  • Meeting arrangements (venue selection, hospitality, travel)

  • Documentation including invitations, agendas and feedback forms

  • Mandatory information for meetings documents

  • Identifying the risks associated with varying meeting types (e.g. stand content and speaker slides)

  • Speakers, disclosure & FMV

  • Conference delegates

Dates Available

16 Jan 2020

5 Mar 2020

29 Apr 2020

23 June 2020

3 Sept 2020

4 Nov 2020

6 Feb 2020

19 Mar 2020

14 May 2020

9 July 2020

23 Sept 2020

19 Nov 2020

24 Feb 2020

1 Apr 2020

5 June 2020

27 July 2020

21 Oct 2020

30 Nov 2020

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