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
- Advanced Analytical Techniques
- AI & Machine Learning in Biologics
- Biologics Innovation & Design
- Biomanufacturing & Process Optimization
- Biosimilar Interchangeability & Substitution
- Biosimilars in Oncology & Autoimmune Disorders
- Biosimilars: Market Access & Adoption
- Clinical Trials & Real-World Evidence
- Digital Transformation in Biologics
- Future of Biologics: Gene & Cell Therapy Integration
- Global Biosimilars Market Trends
- Immunogenicity: Risk & Regulation
- Monoclonal Antibodies & Therapeutics
- Next-Gen Biosimilars & Pipeline Trends
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- Targeted Therapies - Personalizedmedicine-2025 (Switzerland)
- Targeted Therapies in Cardiovascular Regeneration - Cardiovascular-2025 (France)
- Targeting the Renin-Angiotensin-Aldosterone System (RAAS) - Cardiovascular-2025 (France)
- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Next Generation Approach of Antibiotics - Antibiotics Resistance 2025 (Canada)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Spain)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Transdermal and Intradermal Delivery Systems - Drug Delivery-2025 (Netherlands)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Trending: Digital Health and Telemedicine for Rare Care - ORPHAN DRUGS 2025 (France)
- Types of Formulations - Formulations 2025 (France)
- Vaccine Delivery Technologies - Drug Delivery-2025 (Netherlands)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2025 (France)
- Veterinary Pharmacology - Pharmacology-2025 (Spain)
- Women in Rare Disease Leadership and Science - ORPHAN DRUGS 2025 (France)