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November 2009
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Nov 2009
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Fri, Nov 27, 2009


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1

2
• euroPLX 41 Barcelona (Spain)
• Advances & Challenges in Label-Free Technologies for Drug Discovery
• PHARMACEUTICAL REGULATORY AFFAIRS IN LATIN AMERICA
• Project Management for Phase 1 & 2 Clinical Trials
• THE PHARMA MINI MBA ~ MANAGEMENT FORUM'S WINTER SCHOOL
• BIO-Europe 2009
3
• euroPLX 41 Barcelona (Spain)
• Advances & Challenges in Label-Free Technologies for Drug Discovery
• PHARMACEUTICAL REGULATORY AFFAIRS IN LATIN AMERICA
• Project Management for Phase 1 & 2 Clinical Trials
• Selecting and Managing CROs
• Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products
• THE PHARMA MINI MBA ~ MANAGEMENT FORUM'S WINTER SCHOOL
• BIO-Europe 2009
4
• PHARMACEUTICAL REGULATORY AFFAIRS IN LATIN AMERICA
• Selecting and Managing CROs
• Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products
• Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
• THE PHARMA MINI MBA ~ MANAGEMENT FORUM'S WINTER SCHOOL
• THE EU PHARMACEUTICAL DOSSIER ~ CTD MODULES 2.3 AND 3
• BIO-Europe 2009
5
• CHINA BIOMEDICAL INNOVATIONS CONFERENCE 2009
• Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
• Effective Laboratory Safety Management
• Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
• FDA Inspections: What To Expect And How To Prepare
• THE EU PHARMACEUTICAL DOSSIER ~ CTD MODULES 2.3 AND 3
• 15th Detection Technologies
6
• CHINA BIOMEDICAL INNOVATIONS CONFERENCE 2009
• Effective Laboratory Safety Management
• Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
• FDA Inspections: What To Expect And How To Prepare
• 15th Detection Technologies
7

8

9
• How to Implement Risk Management Principles and Activities Within a Quality Management System
• Cleanroom Microbiology for the Non-Microbiologist
• Writing Effective Standard Operating Procedures and Other Process Documents
• Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval
• 7th Annual Vaccines: All Things Considered
10
• How to Implement Risk Management Principles and Activities Within a Quality Management System
• Cleanroom Microbiology for the Non-Microbiologist
• Writing Effective Standard Operating Procedures and Other Process Documents
• Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval
• Principles of Organic Chemistry
11
• 3rd Annual Stability Testing Conference
• Pre-Conference Seminar QbD IN INHALATION PRODUCT DEVELOPMENT
• Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval
• Principles of Organic Chemistry
• Sterilization Procedures: Technology, Equipment and Validation
• Reporting Failure Investigations and Process Deviations
• PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA

12
• 3rd Annual Stability Testing Conference
• INHALED DRUG DELIVERY (IDD)
• Sterilization Procedures: Technology, Equipment and Validation
• Reporting Failure Investigations and Process Deviations
• Preparing the CMC Section for NDAs/INDs/CTDs
• Writing in the Regulated Environment When English Is Your Second Language
• Principles of Analytical Chemistry
• PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA

13
• INHALED DRUG DELIVERY (IDD)
• Reporting Failure Investigations and Process Deviations
• Preparing the CMC Section for NDAs/INDs/CTDs
• Writing in the Regulated Environment When English Is Your Second Language
• Principles of Analytical Chemistry
• Surviving as a Woman in Science
14

15

16
• 3rd Annual Contract Manufacturing in Pharma and Biotech Conference
• Chromatin: Structure & Function Conference 2009
• SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development
• GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India
• Good Clinical Practices (GCPs)
• SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development
• Generic Medicine: IP / Legal and Regulatory Issues
17
• 3rd Annual Contract Manufacturing in Pharma and Biotech Conference
• Chromatin: Structure & Function Conference 2009
• Good Clinical Practices (GCPs)
• Pharmaceutical Water Systems - Contemporary Technology & Compliance
• SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development
• LATEST DEVELOPMENTS IN PHARMACOVIGILANCE

18
• 3rd Annual Contract Manufacturing in Pharma and Biotech Conference
• Chromatin: Structure & Function Conference 2009
• Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing
• GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India
• Good Clinical Practices (GCPs)
• Pharmaceutical Water Systems - Contemporary Technology & Compliance
• Root Cause Analysis for CAPA
• LATEST DEVELOPMENTS IN PHARMACOVIGILANCE
• Generic Medicine: IP / Legal and Regulatory Issues
• REGULATORY BASICS by HALLORAN Consulting Group
19
• Chromatin: Structure & Function Conference 2009
• Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing
• European Regulatory Affairs
• Root Cause Analysis for CAPA
• Adverse Drug Events - Reporting & Regulatory Requirements
• Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products
• Bridging the GAAP to IFRS
20
• Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing
• European Regulatory Affairs
• GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India
• Root Cause Analysis for CAPA
• Adverse Drug Events - Reporting & Regulatory Requirements
• Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products
• One Medicine: Comparative Aspects of Research and Clinical Diagnosis in Allergic Disease
• Generic Medicine: IP / Legal and Regulatory Issues
21

22

23
• BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application
• Non-Clinical Safety Sciences and Their Regulatory Aspects
24
• BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application
• Non-Clinical Safety Sciences and Their Regulatory Aspects
• SUPPLIER QUALITY MANAGEMENT - How well do you know your Suppliers and Supply Chain?
• Small Scale Bio-production: Beyond the Flask.

25
• Non-Clinical Safety Sciences and Their Regulatory Aspects
26
• MEDICAL DEVICE REGULATORY AFFAIRS IN THE MIDDLE EAST
• Non-Clinical Safety Sciences and Their Regulatory Aspects
27
• Non-Clinical Safety Sciences and Their Regulatory Aspects
• INTRODUCTORY OVERVIEW OF THE PHARMACEUTICAL INDUSTRY
• Role of RNA structures in post-transcriptional control of gene expression

28

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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