Module 6

02/10/2024

Key Collaboration and Communication Plans Key considerations

External Stakeholders are key customers too

• Proactive co-ordinated communication globally

• Governance of reporting to financial markets vs. relationship with regulatory agency

• Co-ordinating release of phase III study results with major congresses and link with regulatory agency communication

▪ Phase III manuscripts/ Satellite symposium/ Congresses

─ Speaker may not hold the same view as the company

─ Study investigators need to express their view on the data since they are the experts

• Publications externally serves different purposes

Limitations on advertising

May need prior health authority vetting /approval.

▪

▪ A mechanism for providing additional information to prescribers, i.e. QoL data not covered in label, ADR reporting requirements

• Different types of journals – Timing is key !

High impact journals; Lancet, NEJM

▪

▪ Specialised journals; ophthalmology, neuroscience

One Q&A co-ordinated global messaging

•

▪ Be ready to proactively and reactively answer questions to Journalists, media press releases, healthcare professionals, patients, shareholders

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

39

Key Product Launch Activities

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

40

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