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Overview of Regulatory Product Information

The Organisation for Professionals in Regulatory Affairs
Course summary
1 day
Online courses

Course description

Overview of Regulatory Product Information

This one day workshop from regulators and industry experts will provide an insight on European SmPC, package leaflet (PL) and label preparation and implementation, from a strategic and practical point of view.

Suitability - Who should attend?

Suitable for

  • Less experienced regulatory professionals who require comprehensive information on product information
  • Experienced professionals who are newcomers in the product information area
  • Anyone who wishes to update/refresh their knowledge in product information.

Outcome / Qualification etc.

Benefits to participants

  • Meet and learn from experts in the field
  • Learn by doing - participate in case studies and interactive sessions
  • Build a network to support the rest of your career
  • Overview of the European SmPC, PL and labelling legislation and guidelines including an overview of the EMA QRD templates, readability, Braille, excipients and translations and timings
  • Practical advice on how to comply with European labelling legislation and guidelines, for products registered through the centralised, decentralised and mutual recognition or national procedures
  • Cross functional planning
  • Overview of future developments in labelling regulations and guidelines
  • Guidance on practical aspects of pack changes including how to effectively manage the implementation of pack changes resulting from changes to the SmPC while meeting legislative and ethical requirements
  • Outline of the contentious sections, and overcoming common pitfalls

Training Course Content

  • The Company Core Data Sheet
  • SmPC: Regulator’s perspective
  • Strategy for the Development of the Optimal SmPC
  • Case Study - SmPCs
  • Labels and Leaflets: Regulator’s perspective
  • Preparation of the Label and Leaflet: Industry perspective
  • Implementation of Labels and Leaflets: Industry perspective
  • Case Study – Labels and Leaflets


The full tuition price for Members is 660 GBP. The price for Non-members is 810 GBP

About provider

The Organisation for Professionals in Regulatory Affairs

The Organisation for Professionals in Regulatory Affairs (TOPRA)

The Organisation for Professionals in Regulatory Affairs (TOPRA) has encouraged excellence in the area of regulatory affairs for pharmaceuticals, veterinary medicines and medical devices since 1978. TOPRA's mission is to represent and promote the profession of healthcare regulatory affairs globally....

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Contact info

The Organisation for Professionals in Regulatory Affairs

3 Harbour Exchange, 6th Floor
E14 9GE London

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