Brooke J

@brooke_journey

Pharmacy and Regulatory Affairs Specialist

Reino Unido

Inglês

Algumas informações são exibidas no idioma inglês.

Sobre mim

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.... Saiba mais

Habilidades