Brooke J

@brooke_journey

Pharmacy and Regulatory Affairs Specialist

Regno Unito

Inglese

Alcune informazioni sono riportate in lingua inglese.

Chi sono

I hold a Doctor of Pharmacy degree with strong expertise in adverse drug reaction (ADR) monitoring and reporting, patient care, counseling, prescription review, and drug interaction assessment. My experience also includes FDA regulatory modules, eCTD submissions, ICH E6 and ICH E3 guidelines, and Clinical Study Report (CSR) preparation. I am passionate about Regulatory Affairs and skilled at developing GCP- and GMP-compliant clinical study reports, protocols, statistical analyses, and dossier submissions, ensuring accuracy, compliance, and high-quality documentation.... Continua a leggere

Competenze