Global Regulatory Intelligence
Ever-proliferating and changing global regulations generate complex challenges of execution in global market clearance operations.
Mission-critical decisions are delayed, trapping new international revenue until market clearance process issues are resolved. Workflow is confounded as information conflicts from sales-focused distributors, newly-appointed foreign regulators, and legacy resources are reconciled- and as definitive answers are sought. Governance is compromised as information gaps reduce assurance levels and impair risk management of clearance-related penalties, fines, and legal costs.
And the high level of business performance required to create value from ongoing medtech industry consolidation is not achievable, since global market clearance operations are incapable of rapidly completing new market clearance submissions for newly-acquired product lines.
Unlike repackaged RI databases designed for the pharmaceutical industry, the clinivation Worldview Enterprise Solution for On-Demand Global Regulatory Intelligence accelerates the market clearance cycle.
- Role of global regulatory affairs
- Key regulatory functions and activities
- Global regulatory affairs organization
- Global regulatory agency interactions
- Global regulatory strategy
Related Conference of Global Regulatory Intelligence
June 06-07, 2018
International Conference & B2B on Pharma Research and Development
Philadelphia, Pennsylvania, USA
June 08-09, 2018
8th International Conference and Exhibition on Pharma Audit, GMP, GCP & Quality Control
Philadelphia, Pennsylvania, USA
June 08-09, 2018
8th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR
Philadelphia, Pennsylvania, USA
June 27-28, 2018
4thInternational Conference on Drug Discovery, Designing Chemistry and Pharmaceutical Analysis
Vancouver, British Columbia, Canada
August 29-30, 2018
International Conference And Exhibition on Drug Safety & Pharmacovigilance
Toronto, Canada
November 15-16, 2018
14th International Conference on Generic Drugs and Biosimilars
Frankfurt, Germany
Global Regulatory Intelligence Conference Speakers
Recommended Sessions
- Best Industry Practices
- Biologics and Biosimilars
- Clinical Affairs and Regulatory Strategies
- Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals:
- Global Regulatory Intelligence
- GMP in Food Industry
- Good Clinical Practices & Good Laboratory Practices
- Impact of Brexit on Regulatory Framework
- Intellectual Property Rights
- Marketing Authorizations
- Medical Devices and Combination Product Regulations
- Penalties for Regulatory Non-compliance
- Regulatory Affairs
- Regulatory Affairs in Pharmacovigilance
- Regulatory Challenges for Medical Devices
- Regulatory Communications and Submissions
- Regulatory Requirements for Pharmaceuticals
- Regulatory Strategies and developments
- Role of c in cGMP
- Softwares in GMP and GCP
Related Journals
Are you interested in
- Adverse Drug Reactions - Drug Safety 2018 (Canada)
- Analytical method Quality Auditing - GMP and Pharma Audit 2018 (USA)
- Analytical strategies for pharmaceutical products - Pharma Research 2018 (USA)
- Anesthesia in Pain Treatment - Pain Medicine 2018 (USA)
- API: Active Pharmaceutical Ingredients - Pharma Research 2018 (USA)
- Array of clinical trials in biosimilars - Generic Biosimilars 2018 (Germany)
- Auditing Deviations, Product Complaints, and CAPA Systems - GMP and Pharma Audit 2018 (USA)
- BCS & IVIVC Based Biowaivers - Asian Biosimilars 2018 (Japan)
- Best Industry Practices - Regulatory Affairs 2018 (USA)
- Bio-Pharmaceutics - Pharma Congress 2018 (Poland)
- Bioavailability/Bioequivalence on Biopharmaceutical Products - Euro Biopharma 2018 (Netherlands)
- Bioequivalence Assessment - Asian Biosimilars 2018 (Japan)
- Biologics & Biosimilars - Pharma Congress 2018 (Poland)
- Biologics and Biosimilars - Regulatory Affairs 2018 (USA)
- Biologics and Biosimilars - Euro Biopharma 2018 (Netherlands)
- Biopharmaceutical Companies & Market Analysis - Euro Biopharma 2018 (Netherlands)
- Biopharmaceutical Pharmacovigilance - Euro Biopharma 2018 (Netherlands)
- Biopharmaceutical Sciences - Drug Safety 2018 (Canada)
- Biopharmaceuticals - Euro Biopharma 2018 (Netherlands)
- Biopharmaceutics: Drug Discovery and Development - Euro Biopharma 2018 (Netherlands)
- Biosimilar and biologics - Generic Biosimilars 2018 (Germany)
- Biosimilar Companies and Market Analysis - Asian Biosimilars 2018 (Japan)
- Biosimilar development challenges - Generic Biosimilars 2018 (Germany)
- Biosimilar Market and Cost Analysis - Asian Biosimilars 2018 (Japan)
- Biosimilars Analytical Strategies - Asian Biosimilars 2018 (Japan)
- Biosimilars differentiated through novel drug delivery technologies - Generic Biosimilars 2018 (Germany)
- Biosimilars Research Pipeline - Asian Biosimilars 2018 (Japan)
- Biosimilars uptake and patient safety - Generic Biosimilars 2018 (Germany)
- Biotechnological Products - Euro Biopharma 2018 (Netherlands)
- Brexit Effect on Biosimilars - Asian Biosimilars 2018 (Japan)
- Cardiovascular Drug Discovery - Drug Designing 2018 (Canada)
- Case study mitigating risk in biosimilar development - Generic Biosimilars 2018 (Germany)
- Cellular and Gene Therapy - Euro Biopharma 2018 (Netherlands)
- Challenges in Developing Biosimilars - Asian Biosimilars 2018 (Japan)
- Chronicles of biosimilar production facility - Generic Biosimilars 2018 (Germany)
- Clinical Affairs and Regulatory Strategies - Regulatory Affairs 2018 (USA)
- Clinical and Bioanalytical laboratory Audits - GMP and Pharma Audit 2018 (USA)
- Clinical and Hospital Pharmacy - Pharma Congress 2018 (Poland)
- Clinical Audit in Pharmaceutical Development - GMP and Pharma Audit 2018 (USA)
- Clinical Data Management and Analytics - Drug Safety 2018 (Canada)
- Clinical Database Management - Drug Safety 2018 (Canada)
- Clinical Research and Statistics - Drug Safety 2018 (Canada)
- Clinical Studies on Biosimilars - Asian Biosimilars 2018 (Japan)
- Clinical Trial Protocols - Drug Safety 2018 (Canada)
- Clinical Trial Site Selection and Management - Drug Safety 2018 (Canada)
- Clinical Trials and Clinical Research - Pharma Congress 2018 (Poland)
- Clinical trials and Pharmacovigilance - Pharma Research 2018 (USA)
- Clinical Trials and Regulatory Affairs - Drug Designing 2018 (Canada)
- clinical Trials on Biopharmaceutical Products - Euro Biopharma 2018 (Netherlands)
- Computational Molecular Biology - Drug Designing 2018 (Canada)
- Computer Aided Drug Design (CADD) - Drug Designing 2018 (Canada)
- Contract & Sterile/Aseptic Manufacturing - GMP and Pharma Audit 2018 (USA)
- Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals - GMP and Pharma Audit 2018 (USA)
- Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals: - Regulatory Affairs 2018 (USA)
- Current Regulations and Quality Standards - GMP and Pharma Audit 2018 (USA)
- Developing biosimilars and biobetters - Generic Biosimilars 2018 (Germany)
- Diversity in Industrial Clinical Trials and Clinical Research - Drug Safety 2018 (Canada)
- Drug Delivery and Targeting - Drug Designing 2018 (Canada)
- Drug Delivery System of Biopharmaceutical Products - Euro Biopharma 2018 (Netherlands)
- Drug Designing and Molecular Modelling - Drug Designing 2018 (Canada)
- Drug Discovery and Development - Drug Designing 2018 (Canada)
- Drug discovery and NCEs - Pharma Research 2018 (USA)
- Drug Discovery in Preclinical Research - Drug Designing 2018 (Canada)
- Drug Disposition & Pharmacokinetics - Euro Biopharma 2018 (Netherlands)
- Drug Dissolution of Biopharmaceutical Products - Euro Biopharma 2018 (Netherlands)
- Drug Safety - Drug Safety 2018 (Canada)
- Drug Targeting and Design - Pharma Congress 2018 (Poland)
- Drugs Regulations - Drug Safety 2018 (Canada)
- Emerging Biosimilars in Therapeutics - Asian Biosimilars 2018 (Japan)
- Emerging Trends in Biosimilars - Asian Biosimilars 2018 (Japan)
- Entrepreneurs Investment Meet - Asian Biosimilars 2018 (Japan)
- Entrepreneurs Investment Meet - Euro Biopharma 2018 (Netherlands)
- Entrepreneurs investment meet - Generic Biosimilars 2018 (Germany)
- Excipient Qualification and Supply Chain Controls - GMP and Pharma Audit 2018 (USA)
- Formulation Development - GMP and Pharma Audit 2018 (USA)
- Formulations and NDDS - Pharma Research 2018 (USA)
- Generic drugs, generic pills and generic medication - Generic Biosimilars 2018 (Germany)
- Generics and biosimilars industry strategy - Generic Biosimilars 2018 (Germany)
- Global generic trends and global pharma market - Generic Biosimilars 2018 (Germany)
- Global Regulatory Intelligence - Regulatory Affairs 2018 (USA)
- Globalization of Biosimilars - Asian Biosimilars 2018 (Japan)
- GMP in Food Industry - Regulatory Affairs 2018 (USA)
- GMP in Food Industry - GMP and Pharma Audit 2018 (USA)
- GMP in Microbiology and Biotechnology - GMP and Pharma Audit 2018 (USA)
- GMP, GCP and quality control - Generic Biosimilars 2018 (Germany)
- Goals and Strategies to Meet Audit Requirements - GMP and Pharma Audit 2018 (USA)
- Good Clinical Practices & Good Laboratory Practices - Regulatory Affairs 2018 (USA)
- Good Clinical Practices & Good Laboratory Practices - GMP and Pharma Audit 2018 (USA)
- Good Manufacturing Practices: The Gap within - GMP and Pharma Audit 2018 (USA)
- Good Pharmacovigilance Practice - Drug Safety 2018 (Canada)
- Hospital and Indutrial Pharmacy - Drug Safety 2018 (Canada)
- Impact of Brexit on Regulatory Framework - Regulatory Affairs 2018 (USA)
- Importance of Audit in Pharmaceutical Industry - GMP and Pharma Audit 2018 (USA)
- Industrial and Physical Pharmacy - Pharma Congress 2018 (Poland)
- Innovation and technology for biosimilar development - Generic Biosimilars 2018 (Germany)
- Intellectual Property Rights - Asian Biosimilars 2018 (Japan)
- Intellectual Property Rights - Regulatory Affairs 2018 (USA)
- Latest Biosimilars in Asian Scenario - Asian Biosimilars 2018 (Japan)
- Legal Issues and BPCI Act - Asian Biosimilars 2018 (Japan)
- Licensing, manufacturing and health economics - Generic Biosimilars 2018 (Germany)
- Marketing Authorizations - Regulatory Affairs 2018 (USA)
- Medical and Clinical Case Reports - Drug Safety 2018 (Canada)
- Medical Devices and Combination Product Regulations - Regulatory Affairs 2018 (USA)
- Medicinal Chemistry in Modern Drug Discovery - Drug Designing 2018 (Canada)
- Nanomedicine and Biomedical Applications - Pharma Congress 2018 (Poland)
- Nanotechnology in Drug Discovery - Drug Designing 2018 (Canada)
- Natural products Drug Discovery - Drug Designing 2018 (Canada)
- Natural Supplements for Pain Management - Pain Medicine 2018 (USA)
- Novel Drug Delivery Systems - Pharma Congress 2018 (Poland)
- Novel Therapeutics in Drug Designing - Drug Designing 2018 (Canada)
- Office of generic drugs (OGD) - Generic Biosimilars 2018 (Germany)
- Orofacial Pain - Pain Medicine 2018 (USA)
- Pain Management - Pain Medicine 2018 (USA)
- Pain Management Market - Pain Medicine 2018 (USA)
- Pain Management Nursing - Pain Medicine 2018 (USA)
- Pain Management Specialist - Pain Medicine 2018 (USA)
- Pain Medications - Pain Medicine 2018 (USA)
- Pain Medicine - Pain Medicine 2018 (USA)
- Patent access and intellectual property and FDA regulations - Generic Biosimilars 2018 (Germany)
- Penalties for Regulatory Non-compliance - Regulatory Affairs 2018 (USA)
- Pharma Market Research - Pharma Research 2018 (USA)
- Pharma pricing and market access - Generic Biosimilars 2018 (Germany)
- Pharmaceutical Analysis - Pharma Congress 2018 (Poland)
- Pharmaceutical and Biomedical Analysis - Drug Designing 2018 (Canada)
- Pharmaceutical Auditing for OTC Drugs - GMP and Pharma Audit 2018 (USA)
- Pharmaceutical Biotechnology - Pharma Congress 2018 (Poland)
- Pharmaceutical Biotechnology and Clinical Drug Evaluation - Drug Designing 2018 (Canada)
- Pharmaceutical Chemistry - Pharma Congress 2018 (Poland)
- Pharmaceutical Formulation - Drug Designing 2018 (Canada)
- Pharmaceutical Formulation - Pharma Congress 2018 (Poland)
- Pharmaceutical Manufacturing - Pharma Congress 2018 (Poland)
- Pharmaceutical Manufacturing,Scale Up and Tech transfer - Pharma Research 2018 (USA)
- Pharmaceutical Microbiology - Pharma Congress 2018 (Poland)
- Pharmaceutical Nanotechnology - Pharma Congress 2018 (Poland)
- Pharmaceutical Packaging - Pharma Congress 2018 (Poland)
- Pharmaceutical Packaging and Logistics - Pharma Research 2018 (USA)
- Pharmaceutical Process Validation - Pharma Congress 2018 (Poland)
- Pharmaceutical Regulatory Affairs And IPR - Euro Biopharma 2018 (Netherlands)
- Pharmaceutical Research and Development - Drug Designing 2018 (Canada)
- Pharmacoeconomics - Pharma Research 2018 (USA)
- Pharmacogenetics and Genomics - Pharma Congress 2018 (Poland)
- Pharmacognosy and Phytochemistry - Pharma Congress 2018 (Poland)
- Pharmacological Sciences - Pharma Congress 2018 (Poland)
- Pharmacology and drug developement - Generic Biosimilars 2018 (Germany)
- Pharmacovigilance - Euro Biopharma 2018 (Netherlands)
- Pharmacovigilance and Drug Safety - Pharma Congress 2018 (Poland)
- Pharmacovigilance and safety of biosimilars - Generic Biosimilars 2018 (Germany)
- Pharmacovigilance of Biosimilars - Asian Biosimilars 2018 (Japan)
- Pharmacy Education and Practice - Pharma Congress 2018 (Poland)
- Physical Medicine and Rehabilitation - Pain Medicine 2018 (USA)
- Pre-Clinical and Clinical Trials - Drug Safety 2018 (Canada)
- Protein biotherapeutics and biosimilars - Generic Biosimilars 2018 (Germany)
- QC & QA: Quality control and Quality assurance - Pharma Research 2018 (USA)
- Quality Assurance - GMP and Pharma Audit 2018 (USA)
- Quality Assurance Audits in Pharma Industries - GMP and Pharma Audit 2018 (USA)
- Quality Assurance, Quality Control and Audit - GMP and Pharma Audit 2018 (USA)
- Quality by design(QbD) approach - Pharma Research 2018 (USA)
- Quality Control - GMP and Pharma Audit 2018 (USA)
- Quality control and R&D - Generic Biosimilars 2018 (Germany)
- Quality Management System in Testing Laboratories - GMP and Pharma Audit 2018 (USA)
- Regulatory Affairs - Regulatory Affairs 2018 (USA)
- Regulatory Affairs and Intellectual Property Rights - Pharma Congress 2018 (Poland)
- Regulatory Affairs in Pharmacovigilance - Regulatory Affairs 2018 (USA)
- Regulatory Approach for Biosimilars - Asian Biosimilars 2018 (Japan)
- Regulatory Authority Compliance - Pharma Research 2018 (USA)
- Regulatory Challenges for Medical Devices - Regulatory Affairs 2018 (USA)
- Regulatory Communications and Submissions - Regulatory Affairs 2018 (USA)
- Regulatory Requirements for Pharmaceuticals - Regulatory Affairs 2018 (USA)
- Regulatory Strategies and developments - Regulatory Affairs 2018 (USA)
- Role of c in cGMP - Regulatory Affairs 2018 (USA)
- Softwares in GMP and GCP - Regulatory Affairs 2018 (USA)
- Softwares in GMP and GCP - GMP and Pharma Audit 2018 (USA)
- Storage, Distribution, Transportation - GMP and Pharma Audit 2018 (USA)
- The Role of c in cGMP - GMP and Pharma Audit 2018 (USA)
- Therapeutic Biological Products - Euro Biopharma 2018 (Netherlands)
- Validation - GMP and Pharma Audit 2018 (USA)