Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Links to selected learning resources from different regulatory agencies, technology forums, industry leaders (USFDA, EMA, EDQM, WHO, ISPE, PICS, APIC, CEFIC, Industry leaders)– Trainings, Webinars, Seminars, Webcasts, Workshops are listed. Many of the programmes are free

Topic/Subjects Agency/Provider Date Type Free/Paid
Regulatory perspectives in Good Clinical Practice, Bioequivalence and good Pharmacovigilance practices Practical application of ICH E6(R3), Challenges in bioequivalence studies, Bioequivalence case studies, , Pharmacovigilance inspection metrics, common inspection findings and harmonization efforts FDA/MHRA/Health Canada 02 Jun 2026 Symposium Free
Bioequivalence Innovations for Generic Oral Products Biowaivers, Bridging, Development for Oncology and Discontinued Products, Unavailable reference listed drugs or standards, reformulated drugs to mitigate nitrosamine risks, alternative BE strategies CRCG & FDA 05 May 2026 Virtual Workshop Free
Regulatory Education for Industry (REdI) - Innovative Regulatory Strategies Provide strong, basic foundation in the FDA’s regulatory requirements, current activities, Innovative Regulatory Strategies to Transform Medical Products USFDA 19 May 2026 Conference Free
Modernizing Bioequivalence Approaches for Topical & Transdermal Products (ADGD) Alternative BE approaches for topical products. strategies for topical and transdermal delivery systems, when in vivo studies such as sensitization studies are needed ..... FDA CDER, SBIA 10 Sep 2026 Virtual Workshop Free
FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates - 09/29/2026 | FDA Establishment registration and drug listing submissions, Structured Product Labeling (SPL) submissions, drug amount reporting requirements, National Drug Code Format, Drug Label Barcode Requirements FDA CDER, SBIA 29 Sep 2026 Virtual Workshop Free
Trainings and Webinars Archives

The trainings and webinars archives page lists carefully selected useful and informative free learning resources available online. These webinars, workshops, seminars and webcasts are programmes that occurred in the past provide valuable information, knowledge and learning on various GMP & Regulatory topics. Please click here to go to the page - Trainings and Webinars Archives