Certificate Course in Drug Regulatory Affairs (DRA)

Understand the FDA drug approval process from development and animal testing through phase I–III trials, NDA review, labeling, facility inspection, and post marketing surveillance.

Outlines preclinical steps in new drug development, including in vivo and in vitro studies, target identification, chemical selection, safety and efficacy evaluation, formulation, manufacturing, and GLP considerations.

Explore the investigational new drug application process with the FDA, including eligibility, regulatory holds, contents, and special IND types for emergencies, treatment, and noncommercial research.

Learn the NDA process for the US FDA marketing approval, including CTD format, data requirements, review steps, labeling, and site inspections.

Explore the abbreviated new drug application (ANDA) pathway, patent protection up to 20 years, Hatch-Waxman Act exclusivity, and PARAs guiding first-to-file generics and FDA requirements.

Explore ANDA-2 certification, patent non-infringement and expiry dynamics, 180-day exclusivity, and FDA timelines, including infringement notices and four possible outcomes determining generic entry.

Understand how ANDA ensures generic drugs are pharmaceutical, bioequivalent, and therapeutically equivalent to reference listed drugs, with CTD submissions to the US FDA and review processes.

Explore generic products, from ordinary and value-added types to those with new delivery system and biogenetics, including branded generics and patent-expired molecules reformulated into line extensions, retargeting, or new products.

Compare innovative and generic drug products, highlighting quality systems, efficacy, manufacturing, excipients, competition, price, packaging, promotion, development timelines, and marketing authorization after patent expiry.

Compare innovator and generic products on availability, standards, stability, regulatory compliance, monographs for generics, brand name, and manufacturing cost, noting discovery and trials drive innovators' development.

Compare NDA and ANDA regulatory reviews, highlighting common points such as labeling, CMC data, site inspections, with India differing by prioritizing bioequivalence data over bioavailability, preclinical, and clinical data.

Explore regulation of pharmaceutical development, manufacturing, and marketing to ensure safe, effective treatments; learn how the Hatch-Waxman Act governs generic approvals, the Orange Book, and patent listings.

Explore how the Orange Book assigns therapeutic equivalence evaluations using codes like AB for bioequivalent products, and how dosage forms—from oral to injectable and topical—determine therapeutic equivalence classifications.

Examine the Orange Book therapeutic equivalence evaluation codes and how bioequivalence data guide regulatory labeling, designation, and decisions on product equivalence.

Drug master files provide confidential details on facilities, processes, packaging, and materials for FDA review; they are voluntary, support NDAs, and come in five types, with Type II most common.

Learn DMF definitions and submission requirements including FDA as agency, holder and agent roles, a letter of authorization, and eCTD format, with DMF status and annual updates.

the dmf review process begins when the agency receives the dmf; if deficiencies exist, the holder receives a deficiency letter and must submit the required information with a transmittal letter.

Contrast applications and drug master files, noting that applications must be filed by applicant with due dates, while dmfs are not mandatory, centralized in a database, and reviewed differently.

Explore the common technical document (ctd), a harmonized cross-region dossier format for human drug submissions covering quality, nonclinical, and clinical data across the FDA, EMA, and Japan.

Compare ASEAN-CTD and ICH-CTD structures, noting module and part differences, summaries location, administrative data, and the emphasis on generics versus detailed body data.

Explore how the electronic common technical document (eCTD) enables electronic submissions from applicants to regulators with a harmonized CTD structure and five modules.

Compare paper CTD and eCTD by highlighting format, navigation, and storage, including binders versus XML navigation and hyperlinks.

Explore regulatory strategy for drug development, including milestones and data needs across preclinical, clinical, and post-approval phases. Learn how to align regulatory submissions with global requirements to secure marketing authorization.

Analyze regulatory strategy across clinical trial phases from drug substance characterization to post-marketing surveillance, emphasizing dose, safety, efficacy, compliance, and interactions with authorities.

Learn the fundamentals of good manufacturing practices, how GMP minimizes contamination, mislabeling, and incorrect potency, and how it governs quality controls across raw materials, processes, and documentation.

Compare GMP and current good manufacturing practices (cGMP): cGMP is a more current, tech-driven standard with extra testing, used in fewer countries at higher cost, unlike GMP's broader, lower-cost reach.

Learn how clinical research uses human volunteers to assess safety and efficacy of drugs and devices, guided by ethics, informed consent, and regulatory trial phases.

Master GMP principles to ensure drug manufacturing meets government regulation, with clear procedures, rigorous documentation, validated processes, quality design, hygiene, contamination control, and regular audits.

The video provides a helicopter view of biologics license applications and the Purple Book, detailing reference product exclusivity, biosimilars, and interchangeability under FDA regulations.

Master meeting etiquette in professional settings by valuing time, presenting a polished appearance, greeting confidently, managing devices, and making confident introductions.

Practice confident, attentive meeting etiquette: maintain eye contact, avoid interruptions, speak clearly, take notes, ask timely questions, share agendas in advance, stay on topic, and provide minutes within 24 hours.

Celebrate course completion, invite feedback and questions, and connect on LinkedIn and Twitter; download your certificate (PDF or JPG) after finishing all lectures, with Udemy issuing it.