№ lp_1_2_29764
Guidance and application form outlining the pilot of the MHRA Real-World Evidence Scientific Dialogue Programme, detailing eligibility, submission process, meeting types, and regulatory expectations for generating and discussing RWE for medicinal products.
Year: 2025
Organization: Medicines and Healthcare products Regulatory Agency (MHRA)
Partner Organization: The National Institute for Health and Care Excellence (NICE)
Document Type: Guidance / Application Form
Subject: Real-World Evidence (RWE) Scientific Dialogue
Target Audience: Pharmaceutical companies, academic institutions, and other organizations generating RWE
Application Period: 10 February 2025 – 4 April 2025
Meeting Dates: May – July 2025
Workshop Dates: June – July 2025
Scope: Medicinal products including drugs, biologics, vaccines, ATMPs; pre- and post-authorisation evidence generation
Exclusions: Medical devices, products under active regulatory procedure
Submission Method: Email to [email protected]
Format: Closed-door meetings or pre-competitive workshops
Page Limit: 3 pages
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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