Introduction

Legislation requires that developers and Marketing Authorisation Holders (MAHs) of medicinal products have pharmacovigilance systems in place that comply in all respects with the requirements of regulatory authorities. This unit provides information on all aspects of ensuring compliance with pharmacovigilance regulations (both pre-marketing and post-marketing) in Europe, the USA, and Japan, including inspection procedures and legal implications.

Aims

• To critically appraise current drug safety and pharmacovigilance rules and processes, regulatory trends, and expectations for compliance.
• To prepare for pharmacovigilance regulatory inspections through critical evaluation of the rules, regulatory expectations, and common mistakes.
• To assess safety data exchange procedures between and within relevant stakeholders including regulatory authorities, MAHs, Clinical Research To assess safety data exchange procedures between and within relevant stakeholders including regulatory authorities, MAHs, Clinical Research Organisations (CROs) and other parties involved in contractual agreements.