Module 1 2021

28/06/2021

US FDA – Agency meetings

• Formal processes and timings but also opportunities for ad hoc and less formal interactions • First impressions can be formal and intimidating • Professional and high quality interactions relax formality and open the way to informal interactions • Building credibility and relationships is critical • Establish strong relationships with the Project Manager, and individual reviewers • Divisional differences by therapy area and leadership • Partnering is expected, not aspirational • Agreements/outcomes are typically honoured

The Organisation for Professionals in Regulatory Affairs

23

Japan PMDA – Consultations

• Pharmaceutical Affairs Consultation on R&D Strategy • Language and processes present significant cultural challenge • Interactions are science led, but may not always appear that way • Involvement of opinion leaders can facilitate interactions • Very strong focus on quality and safety • Check and confirm understanding – especially if using a translator • Agreements/outcomes need to be documented rigorously to ensure a common understanding • Ensure local staff confirm outcomes and expectations

The Organisation for Professionals in Regulatory Affairs

24

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