Clinical Affairs & Regulatory Strategies
An administrative science driven administrative procedure is crucial as a component of today's biopharmaceutical item early advancement arranging. An all-around arranged administrative methodology will adjust the proposed clinical advancement arrangement with business targets, and pre-emptively distinguish challenges, and also, proposed elective/creative ways to deal with new item improvement which influence new measures for confirmation era supporting proceeding with improvement and worldwide business sector approval. An administrative methodology characterizes key issues/difficulties to proactively talk about with Regulatory powers furthermore characterizes key system points of reference that are frequently considered business impetuses driving speculator intrigue and financing. In particular, an auspicious, very much arranged and all around kept up administrative technique, with proactive and collective cooperation with administrative powers, is regularly a separating element for industry pioneers putting up monetarily fruitful and creative items for sale to the public in today's aggressive commercial center. Administrative procedure is a noteworthy segment of fruitful biopharmaceutical item improvement. Covance Global Regulatory Affairs gets ready and keeps up administrative science driven and item particular worldwide administrative systems for some item sorts, e.g., drugs, biologics, drug-gadget mixes, antibodies, quality treatments, cell-treatments, over a scope of restorative territories and full administrative technique support for item improvement activities.
- Documentation
- USFDA, MHRA, EMEA
- NDA
- IND Application
- Clinical trials in emerging markets
- Key product-label attributes
- Regulatory risks
- Regulatory submissions and correspondence
- Pre-clinical and clinical studies
- The New EU Clinical Trial Regulation
Related Conference of Clinical Affairs & Regulatory Strategies
October 31-01, 2024
27th International Conference and Exhibition on Pharmaceutical Formulations
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November 20-21, 2024
15th International Conference onPharmacoepidemiology and Clinical Research
Vancouver, Canada
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18th International Conference and Exhibition on Pharmacovigilance & Drug Safety
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June 23-24, 2025
25th World Congress on Pharmaceutical Sciences and Innovations in Pharma Industry
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Clinical Affairs & Regulatory Strategies Conference Speakers
Recommended Sessions
- Pharmaceutical Audit
- Auditing Deviations, Product Complaints, and CAPA Systems
- Best Industry Practices
- Biologics & Biosimilars
- Clinical Affairs & Regulatory Strategies
- Contract and Sterile/Aseptic Manufacturing
- Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals
- Current Regulations and Quality Standards
- Excipient Qualification and Supply Chain Controls
- Formulation Development
- Global Regulatory Intelligence
- GMP in Food Industry, Microbiology & Biotechnology
- Good Clinical Practices and Good Laboratory Practices
- Good Manufacturing Practices: The Gap Within
- Impact of Brexit on Regulatory Framework
- Intellectual Property Rights
- Medical Device & Combination Products Regulations
- Penalties for Regulatory Non-compliance
- Quality Control & Quality Assurance
- Quality Management System in Testing Laboratories
- Regulatory Affairs
- Regulatory Challenges for Medical Devices
- Regulatory Communications and Submissions
- Regulatory Requirements for Pharmaceuticals
- Softwares in GMP and GCP
- Storage, Distribution, Transportation
- Validation
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- Pharmacokinetics and Pharmacodynamics - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Pharmacokinetics and Pharmacodynamics of Antimicrobial Drugs - Antibiotics Resistance 2024 (Canada)
- Pharmacological Advances and Drug Development - NURSING PHARMACOLOGY 2024 (Netherlands)
- Pharmacological Sciences - Pharma Europe 2025 (Italy)
- Pharmacology - Pharmacology 2024 (Netherlands)
- Pharmacology - Drug Safety 2024 (France)
- Pharmacology - Pharmacoepidemiology Congress 2024 (Canada)
- Pharmacology - Pharmatech 2025 (Canada)
- Pharmacology & Toxicology - Antibiotics Resistance 2024 (Canada)
- Pharmacology and Toxicology - MedTech-2024 (Switzerland)
- Pharmacology and Toxicology - PHARMA MEDICINAL CHEMISTRY 2025 (Canada)
- Pharmacology of Addiction and Substance Abuse - Pharmacology-2024 (France)
- Pharmacology of Aging and Geriatric Medicine - Pharmacology-2024 (France)
- Pharmacology of Antimicrobial Resistance - Pharmacology-2024 (France)
- Pharmacology of Cancer Immunotherapy - Pharmacology-2024 (France)
- Pharmacology of Cardiovascular Therapeutics - Pharmacology-2024 (France)
- Pharmacology of Neurodegenerative Disorders - Pharmacology-2024 (France)
- Pharmacology of Nutraceuticals and Dietary Supplements - Pharmacology-2024 (France)
- Pharmacology of Pain Management and Analgesia - Pharmacology-2024 (France)
- Pharmacology of Rare Diseases - Pharmacology-2024 (France)
- Pharmacology of Respiratory Diseases: - Pharmacology-2024 (France)
- pharmacotheraphy and drug safety - Pharmacoepidemiology Congress 2024 (Canada)
- Pharmacovigilance and Drug Safety - Clinical-Trials-2024 (Canada)
- Pharmacovigilance and Drug Safety - PHARMA CONFERENCE-2025 (Czech Republic)
- Pharmacovigilance and its Significance - Pharmacoepidemiology Congress 2024 (Canada)
- Pharmacovigilance in the Era of Big Data - Pharmacology-2024 (France)
- Pharmacovigilance Significance and Scope - Pharmacology 2024 (Netherlands)
- 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)
- Pre-clinical and Clinical Trails - Pharmacology 2024 (Netherlands)
- 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)
- Recent advances in drug delivery - Drug Devilvery 2024 (UAE)
- Recent Advances in Pharmacology and Toxicology - Pharmacology 2024 (Netherlands)
- Recent Advances in Pharmacology and Toxicology - Pharmacology 2024 (Netherlands)
- Reformulation Research - Drug Safety 2024 (France)
- Regenerative Medicine and Tissue Engineering - Drug Delivery-2024 (France)
- Regulatory Affairs - Formulations 2024 (Netherlands)
- Regulatory affairs - Pharmacoepidemiology Congress 2024 (Canada)
- 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)
- Risk Management - Pharmacoepidemiology Congress 2024 (Canada)
- Safety of drugs and pharmacovigilance - Drug Safety 2024 (France)
- Safety Pharmacology - Pharmacology 2024 (Netherlands)
- Semi-Solid Dosage Forms - Formulations 2024 (Netherlands)
- Smart Drug Delivery Systems - Pharmatech 2025 (Canada)
- Smart Drug Dery Systems - Formulations 2024 (Netherlands)
- Smart Polymers for Drug Delivery - Pharmaceutica-2025 (Canada)
- Solid Dosage Forms - Formulations 2024 (Netherlands)
- 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)
- 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)
- Toxicology - Pharmacology 2024 (Netherlands)
- Translational Research - Personalizedmedicine-2024 (Switzerland)
- Translational Research in Pharmacology and Therapeutics - NURSING PHARMACOLOGY 2024 (Netherlands)
- Types of Formulations - Formulations 2024 (Netherlands)
- USFDA Approved Biosimilars - Eurobiosimilars 2025 (France)
- Vaccine Delivery Systems - Pharmaceutica-2025 (Canada)
- Vaccine Design and Drug Design - PHARMA CONFERENCE-2025 (Czech Republic)
- Wearable Drug Delivery Systems - PHARMA CONFERENCE-2025 (Czech Republic)