Regulatory Harmonization & Compliance
Global alignment of regulatory standards for biologics and biosimilars is critical to reducing development delays, ensuring consistent quality, and facilitating international market access. This theme examines efforts toward harmonization across major agencies including the FDA, EMA, PMDA, TGA, and WHO. Key topics include standardizing biosimilarity assessment, comparability exercises, stability testing, labeling, interchangeability, and naming conventions. Regulatory divergence can lead to costly duplications and delays in patient access; therefore, collaborative pathways, reliance models, and mutual recognition agreements are gaining momentum. Also explored are digital compliance tools, regulatory intelligence platforms, and automated documentation systems that enhance inspection readiness and audit traceability. A special focus will be placed on post-approval surveillance, lifecycle management, and real-world evidence requirements under evolving global frameworks. For manufacturers, navigating varying dossier expectations and approval timelines requires a proactive, well-informed compliance strategy. Attendees will benefit from updates on recent regulatory reforms, agency guidance documents, and future outlooks that promote consistent global standards while safeguarding product integrity and patient safety.
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Regulatory Harmonization & Compliance Conference Speakers
Recommended Sessions
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- Stem Cell and Genetic Clinical Research - Clinical Research 2026 (UK)
- Structure-Based Drug Design and Molecular Docking - Euro MedChem and CADD 2026 (France)
- Sustainable Biologics Manufacturing - Biologics Meet 2026 (UK)
- Synthetic and Green Medicinal Chemistry - Euro MedChem and CADD 2026 (France)
- Synthetic Biology & Bioengineering Approaches - Biotech-2026 (France)
- Target Identification and Validation - Euro MedChem and CADD 2026 (France)
- Targeted Oral and Gastro-Resistant Formulations - Drug Devilvery 2026 (France)
- Targeted Therapies in Cardiovascular Regeneration - Cardiovascular-2026 (France)
- Targeting the Renin-Angiotensin-Aldosterone System (RAAS) - Cardiovascular-2026 (France)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Theranostics and Personalized Medicine - Drug Devilvery 2026 (France)
- Toxicology - Pharmacology 2026 (Italy)
- Toxicology & Safety Pharmacology - Euro Pharmacology 2026 (France)
- Track 01: Digital Marketing in Pharma Industry - Future Pharma 2026 (Netherlands)
- Track 02: The Future of Pharma R&D - Future Pharma 2026 (Netherlands)
- Track 03: Pharmaceutical Chemistry - Future Pharma 2026 (Netherlands)
- Track 04: Pharmaceutical Analysis - Future Pharma 2026 (Netherlands)
- Track 05: Pharmaceutics & Pharmacotherapeutics - Future Pharma 2026 (Netherlands)
- Track 06: Industrial Pharmacy and Physical pharmacy - Future Pharma 2026 (Netherlands)
- Track 07: Clinical and Hospital Pharmacy - Future Pharma 2026 (Netherlands)
- Track 08: Pharmaceutical and healthcare Industry - Future Pharma 2026 (Netherlands)
- Track 09: Regulatory Affairs and Intellectual Property Rights - Future Pharma 2026 (Netherlands)
- Track 10: Pharma and Biotech Financial Outlook - Future Pharma 2026 (Netherlands)
- Track 10: Pharmaceutical Engineering - Pharmaceuticalindustry-2025 (Netherlands)
- Track 11: Novel Drug Delivery Systems - Future Pharma 2026 (Netherlands)
- Track 11: Pharmaceutical Supply Chain Optimization - Pharmaceuticalindustry-2025 (Netherlands)
- Track 12: Drug Discovery and Development - Future Pharma 2026 (Netherlands)
- Track 12: Pharmaceutical Regulatory Requirements - Pharmaceuticalindustry-2025 (Netherlands)
- Track 13: Green and Community Pharmacy - Future Pharma 2026 (Netherlands)
- Track 13: Pharmaceutical Packaging Advances - Pharmaceuticalindustry-2025 (Netherlands)
- Track 14: Big data analytics and Pharma - Future Pharma 2026 (Netherlands)
- Track 1: Digital Parma - Pharmaceuticalindustry-2025 (Netherlands)
- Track 2: R&D Progress: The Path to New Medicines - Pharmaceuticalindustry-2025 (Netherlands)
- Track 3: Clinical Pharmacy and Therapeutics - Pharmaceuticalindustry-2025 (Netherlands)
- Track 4: Pharmaceutical sciences - Pharmaceuticalindustry-2025 (Netherlands)
- Track 5: Pharmaceutical Nanotechnology - Pharmaceuticalindustry-2025 (Netherlands)
- Track 6: Entrepreneurs Investment - Pharmaceuticalindustry-2025 (Netherlands)
- Track 7: The Globalized Pharmaceutical Industry - Pharmaceuticalindustry-2025 (Netherlands)
- Track 8: Drug Discovery - Pharmaceuticalindustry-2025 (Netherlands)
- Track 9: Drug Development - Pharmaceuticalindustry-2025 (Netherlands)
- Transdermal and Intradermal Delivery Systems - Drug-Delivery-2026 (France)
- Transdermal and Topical Drug Delivery - Drug Devilvery 2026 (France)
- Translational Research & Clinical Applications - Biotech-2026 (France)
- Types of Formulations - Formulations 2026 (UK)
- USFDA Approved Biosimilars - Eurobiosimilars 2026 (Italy)
- Vaccine Delivery Technologies - Drug-Delivery-2026 (France)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2026 (UK)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2026 (France)
- Veterinary & Comparative Pharmacology - Euro Pharmacology 2026 (France)
- Wearable and Implantable Drug Delivery Devices - Drug Devilvery 2026 (France)