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
Related Conference of Biopharmaceutical Regulatory Affairs
3rd World Conference on Pharma Industry and Medical Devices
41st International Conference on Drug Discovery and Drug delivery system
16th International Conference on Biosimilars and Pharma Innovations
12th International Conference and Exhibition on Natural Products and Medicinal Plants Research
8th International on Pharmacy and Pharmaceutical Conference
4th International Conference and Expo on Pharmaceutics & Novel Drug Delivery Systems
17th International Conference on Pharmaceutical Education and Practice
31st International Conference on Advanced Clinical Research and Clinical Trials
24th International Conference on Medicinal and Pharmaceutical Chemistry
7th International Conference and Exhibition on Pharmaceutical Development and Technology
18th International Conference and Exhibition on Pharmacovigilance & Drug Safety
25th World Congress on Pharmaceutical Sciences and Innovations in Pharma Industry
10th International Conference on Future Pharma and Innovations
7th European Conference on Advance Clinical Trials and Research
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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- 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)
- 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)