CRED: SmPC/PIL: Strategic issues and planning

Summary of Product Characteristics, Patient Information Leaflets and Labelling: The SmPC and Promotion – Strategic Issues and Planning

Aim

This one day workshop from regulators and industry experts will provide an insight on European SmPC preparation and subsequent promotional materials, from both a strategic and practical point of view. A case study will be used to reinforce learnings of the day.

Who should attend

• The less experienced Regulatory Professional who requires comprehensive information on a subject
• The experienced professional who is a newcomer to a particular regulatory aspect
• Anyone who wishes to update their knowledge in a particular subject area.

Speakers include

• Paul Woods, Global Compliance Policy Director, AstraZeneca, UK
• Beryl Keeley, Unit Manager for Product Information and Advertising, MHRA, UK
• Paul N McCleverty, Senior Director, Regulatory Affairs Speciality Business Unit, Pfizer, UK
• Melanie Eatough, Associate Director, Regulatory Labelling, Stiefel, UK
• Rob Cassells, Director Global Regulatory Affairs (Infectious Diseases), GSK, UK

Course content includes

• Overview of the Directives and Guidelines Relating to Labelling and Promotion
• The role of the SmPC
• Overview of SmPC legislation/guidelines and template
• Current SmPC issues and developments
• The role of promotional material
• Overview of promotional legislation/guidelines
• Current advertising issues and developments
• Strategy for the Development of the Optimal SmPC
• Definition of an optimal SmPC
• Contributing factors to an optimal SmPC
• Key Stakeholders in an optimal SmPC
• Common Pitfalls in the development of an optimal SmPC
• Influence of the optimal SmPC on the development programme
• Competitor analysis
• Overview of the Constraints on Product Labelling, and their Effect on Strategic Planning
• Overview of constraints on product labelling, including the effects of the international community & globalisation
• The preparation and importance of Core Company Safety Information
• Global differences (EU vs. US and other regions)
• Discussion whether EU labelling affects US and Rest Of World labelling/decisions & vice versa
• EU Regulatory Procedures: SmPC maintenance
• Exploring the impact of the choice of application procedure
• Product lifecycle (line extensions, variations, referrals)
• Post-licensing SmPC changes – their impact on promotional material within EU, US and Rest of World as appropriate
• Regulatory Affairs and Promotional Materials.
• What is promotional material?
• When it can be used?
• Who uses it?
• What it cannot be used for
• Who polices the control of promotional material?
• Key contributors to promotional material
• Developments in promotional material and their control
• Affect of