Introduces regulatory principles and requirements governing the development, manufacturing, quality control and marketing of pharmaceutical products. Covers regulatory guidelines, documentation, drug approval processes, GMP and regulatory submissions.
Course Outcome:
CO1: Explain pharmaceutical industry documentation including master formula records, DMFs, generic drug development and regulatory pathways like NDA and ANDA.
CO2: Understand the regulatory requirements and approval processes for APIs, biologics, novel therapies and combination products across major global agencies (FDA, EMA, MHRA, TGA).
CO3: Describe Chemistry, Manufacturing and Controls (CMC) aspects, post-approval regulatory affairs, CTD/eCTD formats and international regulatory harmonization through ICH guidelines.
CO4: Understand nonclinical drug development processes, including global submissions like IND, NDA andA, IMPD dossiers and investigator brochures.
CO5: Develop clinical trial protocols, manage ethical and regulatory aspects of clinical trials (IRB/IEC, informed consent, HIPAA) and apply pharmacovigilance and safety monitoring practices.