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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- Pharmacology of Pain Management and Analgesia - Pharmacology-2024 (France)
- Pharmacology of Rare Diseases - Pharmacology-2024 (France)
- Pharmacology of Respiratory Diseases: - Pharmacology-2024 (France)
- Pharmacovigilance and Drug Safety - Clinical-Trials-2024 (Canada)
- Pharmacovigilance and Drug Safety - PHARMA CONFERENCE-2025 (Czech Republic)
- Pharmacovigilance in the Era of Big Data - Pharmacology-2024 (France)
- Pharmacy Development Services - Pharma Europe 2025 (Italy)
- Pharmacy Education and Practice - PHARMACEUTICAL SCIENCES 2025 (France)
- Photochemistry and Phytopharmaceuticals - PHARMAKON 2025 (Spain)
- Phytochemistry - Natural Products 2024 (Italy)
- Population Health - Personalizedmedicine-2024 (Switzerland)
- Post-Marketing Surveillance Insights - Clinical Trials Congress-2025 (France)
- Post-Trial Closed Communities - Clinical Trials Congress-2025 (France)
- Precision Medicine - Personalizedmedicine-2024 (Switzerland)
- Precision Medicine and Pharmacogenomics - NURSING PHARMACOLOGY 2024 (Netherlands)
- Public Health and Community Nursing - NURSING PHARMACOLOGY 2024 (Netherlands)
- Purpose and Principles of GMP - PHARMACEUTICAL SCIENCES 2025 (France)
- QC & QA: Quality control and Quality assurance - MedTech-2024 (Switzerland)
- Quality by design(QbD) approach - MedTech-2024 (Switzerland)
- Quality Control and Regulatory Considerations in Drug Delivery Systems - Pharmaceutica-2025 (Canada)
- R&D Advancement: Road to New Medicines - PHARMACEUTICAL SCIENCES 2025 (France)
- Radiation-based medicines and biotherapy - Drug Safety 2024 (France)
- Rational Design of Non-Oral Drugs - PHARMA MEDICINAL CHEMISTRY 2025 (Canada)
- Rational Drug Design and Molecular Modeling - PHARMA CONFERENCE-2025 (Czech Republic)
- Real-World Evidence in Clinical Trials - Pharma Europe 2025 (Italy)
- Recent Advancements in Medicinal Pharma - PHARMA MEDICINAL CHEMISTRY 2025 (Canada)
- Reformulation Research - Drug Safety 2024 (France)
- Regenerative Medicine and Tissue Engineering - Drug Delivery-2024 (France)
- Regulatory Affairs and Drug Safety - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Regulatory Affairs and Intellectual Property Rights - Future Pharma 2025 (Netherlands)
- Regulatory Affairs and Quality Assurance in Pharmaceutics - Pharmaceutica-2025 (Canada)
- Regulatory Authority Compliance - MedTech-2024 (Switzerland)
- Regulatory Considerations in Drug Development - Drug Delivery-2024 (France)
- Regulatory Requirements for Pharmaceuticals - PHARMACEUTICAL SCIENCES 2025 (France)
- Regulatory Updates on Biosimilars - Eurobiosimilars 2025 (France)
- Research and development in pharmaceuticals - Drug Safety 2024 (France)
- Research and Trials on Oncology and AIDS - Clinical-Trials-2024 (Canada)
- Role of Gut Microbiome in Cardiovascular Health - Cardiovascular-2025 (France)
- Role of Inflammation in Cardiovascular Diseases - Cardiovascular-2025 (France)
- Safety of drugs and pharmacovigilance - Drug Safety 2024 (France)
- Smart Drug Delivery Systems - Pharmatech 2025 (Canada)
- Smart Polymers for Drug Delivery - Pharmaceutica-2025 (Canada)
- Sustainability and Global Health Biotechnology - Biotech-2025 (France)
- Synthetic and Bioorganic Chemistry - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Targeted Drug Delivery and Controlled Release Systems - PHARMA CONFERENCE-2025 (Czech Republic)
- Targeted Therapies - Personalizedmedicine-2024 (Switzerland)
- Targeted Therapies in Cardiovascular Regeneration - Cardiovascular-2025 (France)
- Targeting the Renin-Angiotensin-Aldosterone System (RAAS) - Cardiovascular-2025 (France)
- Technologies for Formulation - Drug Safety 2024 (France)
- Technology in Pharma Sciences - MedTech-2024 (Switzerland)
- Telemedicine - Personalizedmedicine-2024 (Switzerland)
- The BBB for drug delivery - Drug Safety 2024 (France)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Next Generation Approach of Antibiotics - Antibiotics Resistance 2024 (Canada)
- Therapeutic Drug Transporters - Drug Safety 2024 (France)
- Translational Research - Personalizedmedicine-2024 (Switzerland)
- Translational Research in Pharmacology and Therapeutics - NURSING PHARMACOLOGY 2024 (Netherlands)
- USFDA Approved Biosimilars - Eurobiosimilars 2025 (France)
- Vaccine Delivery Systems - Pharmaceutica-2025 (Canada)
- Vaccine Design and Drug Design - PHARMA CONFERENCE-2025 (Czech Republic)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2025 (France)
- Wearable Drug Delivery Systems - PHARMA CONFERENCE-2025 (Czech Republic)