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December 2009
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Dec 2009
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Fri, Nov 20, 2009


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29

30
• MEDICAL DEVICE REGULATION IN ASIA PACIFIC
• Clinical Trials Design for Medical Devices
• Preparation of FDA Submissions (INDs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
• Active Pharmaceutical Ingredient (API) and Drug Product Specifications
• Good Manufacturing Practices
1
• MEDICAL DEVICE REGULATION IN ASIA PACIFIC
• Clinical Trials Design for Medical Devices
• Preparation of FDA Submissions (INDs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
• Active Pharmaceutical Ingredient (API) and Drug Product Specifications
• Good Manufacturing Practices
• Selecting and Managing CROs
2
• Cleantech Forum XXV- Beijing
• Pharma partnering event PharmaVenue
• Essentials of Clinical Study Management
• Active Pharmaceutical Ingredient (API) and Drug Product Specifications
• Good Manufacturing Practices
• Selecting and Managing CROs
• Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
• CMC Regulatory Compliance for Biopharmaceuticals and Biologics
3
• Pharma partnering event PharmaVenue
• Best Practice in Phase IV Clinical & Observational Research
• Dermatological Advances 2009 Conference
• Essentials of Clinical Study Management
• RISK MANAGEMENT - Applying it and meeting the Challenges for Industry
• Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
• CMC Regulatory Compliance for Biopharmaceuticals and Biologics
• Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
• How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices
• HOW TO WRITE SOPs
• ADVANCED CLINICAL PROJECT MANAGEMENT - 2-Day workshop by HALLORAN Consulting Group
4
• Best Practice in Phase IV Clinical & Observational Research
• Dermatological Advances 2009 Conference
• Essentials of Clinical Study Management
• Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
• CMC Regulatory Compliance for Biopharmaceuticals and Biologics
• Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
• How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices
• CORRECTIVE AND PREVENTATIVE ACTION (CAPA) AND PROCESS IMPROVEMENT
• THE EU COSMETICS DIRECTIVE AND THE NEW COSMETICS REGULATIONS
• RISK MANAGEMENT - Applying it and meeting the Challenges for Industry
• ADVANCED CLINICAL PROJECT MANAGEMENT - 2-Day workshop by HALLORAN Consulting Group
5

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• Vaccine Technology 2009 Conference
• cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices
• Reporting Failure Investigations and Process Deviations
• Stability Programs for Product Shelf Life - From Development to Approval
8
• Vaccine Technology 2009 Conference
• ADVERSE EVENT MANAGEMENT DURING MEDICAL DEVICE CLINICAL STUDIES
• cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices
• Reporting Failure Investigations and Process Deviations
• Stability Programs for Product Shelf Life - From Development to Approval
• EFFECTIVE FAILURE INVESTIGATION

9
• cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices
• Reporting Failure Investigations and Process Deviations
• EFFECTIVE FAILURE INVESTIGATION

10
• DOCUMENT MANAGEMENT & ARCHIVING
• Stem Cells: A Pathway Through the Maze - Oxford University
• Latin America - Understanding Regulatory Compliance Requirements
• Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
• US FDA QUALITY REQUIREMENTS & CAPA FOR MEDICAL DEVICES

11
• HOW TO AUDIT REGULATORY AFFAIRS & CLINICAL TRIALS
• Stem Cells: A Pathway Through the Maze - Oxford University
• Latin America - Understanding Regulatory Compliance Requirements
• Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
• US FDA QUALITY REQUIREMENTS & CAPA FOR MEDICAL DEVICES
• RECURRING QUESTIONS IN BIOTECHNOLOGY AND CHEMISTRY CASE LAW OF THE EPO BOARDS OF APPEAL - AN OVERVIEW FOCUSED ON SOME RECENT DECISIONS AND CONTROVERSIAL POINTS

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• 2nd Annual Oncology Market & Patient Access
• Overview of FDA Regulatory Compliance For Medical Devices
• Software Development for Medical Device Professionals
• PHARMACOVIGILANCE

15
• 2nd Annual Oncology Market & Patient Access
• Overview of FDA Regulatory Compliance For Medical Devices
• Software Development for Medical Device Professionals
• PHARMACOVIGILANCE

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• PHARMACOVIGILANCE

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