CRED Pratical Document Writing and Management 2019


Regulatory role in good communication

Learning Outcomes

 Regulatory Communications  Regulatory Communications e.g. letters to agencies – best practice  Making the Agency letter an effective communication tool for assessors

• You may be the only person who sees the dossier in its entirety • Role in making sure it is integrated • Understanding the assessors requirements (put yourself in their shoes) • Balancing providing sufficient information and optimising lifecycle management • Ensuring legal/regulatory requirements met • Quality control and proof reading • First and overall impressions • First point of contact with the regulators

Example of a GOOD dossier


Regulatory affairs has a pivotal role in communication • Internally and externally • Verbal and written

This impacts on the quality of the dossier, reputation of the company, time to approval and ultimately positively impacts the patients quality of life!


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