Links to selected presentations:  Overview of Regulatory Affairs Overview of Drug Development: the Regulatory Process  Pre-clinical and Clinical Regulatory Overview AFTER REGULATORY APPROVAL THE CHALLENGES REALLY START !  Understanding the Regulatory Landscape – Medical Devices eCTD Drug Development Process WHO Essential Drugs Strategy - Prequalification of drugs for priority diseases WHO Essential Drugs Strategy - WHO’s Role in Assuring the Quality Safety and Efficacy of Medicines: Introduction WHO Pharmaceutical Development  WHO Pharmaceutical Development with focus on Paediatric Formulations Role of FDA in Guiding Drug Development  Ethics Ethics of International Research  Ethical Principles in Clinical Research Ethical issues in health services research Ethical Issues in Translational Research IRB – institutional review board Ethics, data collection and storage Ethics and Clinical Trials in Resource Limited Settings Submissions Regulatory Requirements for Pharmaceutical Submissions in Japan The IND Process Regulatory Issues in Research from IND to NDA Industry Standards for the Electronic Submission of Data to the FDA  GMP Basic Principles of GMP Good manufacturing practice and Regulatory Affairs Regulatory Aspects of Pharmaceutical Excipients Analytical Method Validation in The Drug Development Process Scientific Considerations of Polymorphism in ANDAs Effective Internal GMP Auditing Strategies WHO – Water system validation Introduction and treatment Water purification engineering Inspection of water systems Commission, Qualification & Validation WHO - Basic Principles of GMP Introduction to the training course Quality management Sanitation and hygiene      Qualification and Validation     Complaints and recalls Contract production and analysis Self-inspection and Quality Audits Personnel  Premises      Equipment  Materials Documentation (1)  (2)  Good Practices in Production and Quality Control Sterile production Active Pharmaceutical Ingredient WHO - GMP Inspection Process Introduction The role of the inspector Preparation for an inspection Types of GMP inspection The inspection GCP GCP Regulations Good Clinical Practice Standards Good Clinical Practices and FDA Inspections Clinical Trial Review and Approval Clinical trials Regulatory Perspective: INDs and Initiation of Clinical Trials Protocol Mechanics Clinical Trial Design and Statistical Issues ClinicalTrials.gov FDA AA - Title VIII – an expansion of ClinicalTrials.gov NIH Principles of Clinical Research – Project Management Preparing for the Annual Site Visit Clinical Trial Quality and Compliance: An FDA Perspective Analysis Databases: A Regulatory Perspective Interpreting Positive-Control Clinical Trials  Preclinical Evaluation of Cell and Gene Therapy Products Bridging Studies Bridging Studies - A Genomic Approach Flexible Trial Design: New Techniques in Interim Analysis RAID Training for Investigators: Product and Regulatory Overview Foreign Clinical Studies Clinical Research Management  Conflict of Interest and Human Subjects Progress and Regression in clinical trials Guidelines on Quality Quality Risk Management ICH Q9 History  INTRODUCTION TO ICH Q8 & Q9 GUIDELINES Integrating ICH Q8 principals into the validation of computer systems  ICH Q8 workshop WHO Quality, good manufacturing practice and bioequivalence with a focus on antituberculotics  The ICH guideline E14 on QT/QTc prolongation Multi-Clinic and Multi-National Trials: A regulatory perspective Regulatory Perspectives on the Thorough QT/QTc Study  Multiple Inhibitor Studies What, Why, and How – QT/QTc prolongation ICH V1 An FDA Update Validation Validation: General Overview Validation: Qualification of HVAC & Water Systems Validation: Cleaning validation Validation: Analytical method validation Validation: Computerized system validation Validation: Qualification of systems & equipment Validation: Non sterile product process validation Clinical Pharmacology Bioequivalence of Highly Variable Drugs: Regulatory Perspectives Safety Monitoring Understanding the Requirements of Safety Monitoring Monitoring Drug Safety - poster ICH E2E Pharmacovigilance Planning Risk Management Plan Risk Management in Pharmacovigilance Risk-Based CMC Review Risk Communication in NDA (New Drug Application) Observational Registries: Applications in Safety Evaluation Risk Management through Electronic Enforcement Establishing a MedDRA Safety Surveillance Unit Pharmacists Responsibilities in Clinical Studies General safety of studies in healthy volunteers Clinical Trial Safety Monitoring and Reporting Requirements Adverse Events Adverse Drug Reactions (ADRs) and reporting to The Yellow Card Scheme Inspections Inspections MHRA GCP Inspection Statistics Statistics - Introduction to Clinical Trials Statistics and Validation Data Recent Trends and issues in Therapeutics Gout: Clinical review and trial design issues Cancer and Apoptosis Anticoagulant issues in geriatric population Division of Cellular and Gene Therapies (DCGT) Overview of Activities Gene Therapy: Technical, Regulatory and Stakeholder issues  Functional genomics Post marketing compliance Postmarketing Studies: OND Perspective FDA Role in Post-licensure Vaccine Safety Evaluation Medical Device Outsourcing & the Role of Regulatory Compliance Adverse Drug Reactions (ADRs) and reporting to The Yellow Card Scheme Regulatory Requirements Understanding the Regulatory Landscape Human Gene Therapy: Risk Assessment and Regulatory Requirements HIPAA - Legal Requirements & Regulatory Compliance IND Regulatory Requirements and Recommendations FDA Regulatory Processes and Issues: A Practical Guide Regulation documentation requirements Dossier Requirements (quality part) Key issues in biopesticide regulation Regulatory Considerations in the Development of Topical Microbicides EU REGULATORY ASPECTS IN IMPLEMENTING NATIONAL PRICING POLICY Regulatory Toxicology FDA Human Factors of Medical Devices Regulatory Strategies Managerial and Regulatory Strategies to Improve Drug Use WHO Essential Drugs Strategy Regulatory and Economic Challenges in Biotechnology Manufacturing Medical education and communications: an agency overview Taking Drugs from IND Stage through Phase III
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