Biopharmaceutical Regulatory Affairs
Regulatory Science is the science of advanced standards equipment, and paths to assess the safety, Drug toxicity and quality, potency of all FDA-regulated products. An access to lengthen the programs in regulatory science that leverages what has been well-educated in the development of training programs for translational scientists, and this model for regulatory science program development is being refined and adopted by all of the institutions that are part of the CTSA network. The target audience for such a program is broad, noted that it is necessary to break out of the mindset that regulatory science resides totally with FDA and that the field's purpose is to create a workforce that will function within the FDA. Regulatory science is a collaborative effort that goes beyond FDA. Critical needs for a regulatory science training program understand research and scientific methodology, toxicology, therapeutics, and pharmacology that underpin the regulatory process.
- Biopharma Regulatory challenges
- Regulatory Approvals for Biopharma drug products
- Overview of drug, biologic and device regulatory pathways
- Role of Regulatory Authorities
- BPCI Act
- Hatch-Waxman Act
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Biopharmaceutical Regulatory Affairs Conference Speakers
Recommended Sessions
- Analytical Characterization of Bio therapeutics
- BA/BE on Biopharmaceutical Products& Market analysis
- Biologic Drug development
- Biopharmaceutical companies & market analysis
- Biopharmaceutical Drug Design and Development
- Biopharmaceutical Informatics
- Biopharmaceutical Regulatory Affairs
- Biosimilars and biologic Drugs
- Clinical Trials on Biopharmaceutical products
- Drug Dissolution of Biopharmaceutical Products
- Formulation Studies for Bio therapeutics
- Nanoparticles-An Innovative Drug Delivery System
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- Safety Reporting in Early Phase Trials - Clinical Trials-2026 (UK)
- Semi-Solid Dosage Forms - Formulations 2025 (France)
- Sexually Transmitted Bacterial Infections and Resistance Trends - Euro Antibiotics 2025 (Netherlands)
- Signal Prioritization and Management Techniques - Clinical Trials-2026 (UK)
- Single-Use Technologies in Production - Biologics Meet 2026 (UK)
- Site Management Innovation - Clinical Research 2026 (UK)
- Smart Drug Delivery Systems - Formulations 2025 (France)
- Solid Dosage Forms - Formulations 2025 (France)
- Stem Cell and Genetic Clinical Research - Clinical Research 2026 (UK)
- Stewardship Programs in Human and Animal Health - Euro Antibiotics 2025 (Netherlands)
- Structure-Based Drug Design and Molecular Docking - Euro MedChem and CADD 2025 (France)
- Supply Chain Management - Pharmaceuticals-2025 (France)
- Sustainable Antibiotic Practices and Global Policy - Euro Antibiotics 2025 (Netherlands)
- Sustainable Biologics Manufacturing - Biologics Meet 2026 (UK)
- Synthetic and Bioorganic Chemistry - PHARMACEUTICAL CHEMISTRY 2025 (France)
- Synthetic and Green Medicinal Chemistry - Euro MedChem and CADD 2025 (France)
- Systems Pharmacology and Drug Modeling - Euro Pharmacology 2025 (France)
- Target Identification and Validation - Euro MedChem and CADD 2025 (France)
- Targeted Drug Delivery and Nanomedicine in Infectious Diseases - Euro Antibiotics 2025 (Netherlands)
- Targeted Therapies - Personalizedmedicine-2025 (Switzerland)
- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology - Pharmacology 2026 (Italy)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Germany)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Types of Formulations - Formulations 2025 (France)
- USFDA Approved Biosimilars - Eurobiosimilars 2026 (Italy)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Veterinary Pharmacology - Pharmacology-2025 (Germany)