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September 2009
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Sep 2009
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Fri, Nov 20, 2009


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30

31

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2
• Screening Stem Cells: From Reprogramming to Regenerative
• Screening Stem Cells: From Reprogramming to Regenerative
• Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
• Introduction to Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries
• CMC Regulatory Compliance for Biopharmaceuticals and Biologics
3
• Screening Stem Cells: From Reprogramming to Regenerative
• Screening Stem Cells: From Reprogramming to Regenerative
• Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
• Introduction to Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries
• CMC Regulatory Compliance for Biopharmaceuticals and Biologics
• Detecting Fraud and Misconduct in Clinical Trials
• Preparing the CMC Section for NDAs/INDs/CTDs
• Pediatric Pharmacology
• ComplianceOnline Webinar: Verification of Compendial Methods, Understanding the New USP Chapter <1226>
4
• Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
• Introduction to Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries
• CMC Regulatory Compliance for Biopharmaceuticals and Biologics
• Detecting Fraud and Misconduct in Clinical Trials
• Preparing the CMC Section for NDAs/INDs/CTDs
5

6

7
• 4th Annual Pharmaceutical Anti-Counterfeiting Strategies
• 4th Annual Clinical Site Partnerships in Central & Eastern Europe
8
• Cleantech Forum XXIII, Boston
• 4th Annual Pharmaceutical Anti-Counterfeiting Strategies
• 4th Annual Clinical Site Partnerships in Central & Eastern Europe
• ComplianceOnline Webinar: U.S. FDA cGMP Compliance Audits -- Raising the Bar
9
• Calibration and Qualification of QC Laboratory Instrumentation
• ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
10
• European Regulatory Affairs
• Calibration and Qualification of QC Laboratory Instrumentation
• ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
• Pharmaceutical Production Batch Record Review
• Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
• Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
• ComplianceOnline webinar: Reducing Cleaning Validation Costs Using ICH Q9 and Recent FDA Guidance
11
• European Regulatory Affairs
• ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
• Pharmaceutical Production Batch Record Review
• Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
• Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
12

13

14
• The CTD/eCTD: Building the Marketing Application throughout Clinical Development
• Maximizing Global Patient Recruitment and Retention
• Labeling and Labeling Controls in the Medical Devices Industry
• Preparation of FDA Submissions (INDs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
• Regulation of Advanced Therapy Medicinal Products in Europe, from Clinic to Approval
15
• EU REIMBURSEMENT FOR MEDICAL DEVICES
• 2nd Annual Lyophilisation Conference
• The CTD/eCTD: Building the Marketing Application throughout Clinical Development
• Maximizing Global Patient Recruitment and Retention
• Labeling and Labeling Controls in the Medical Devices Industry
• Preparation of FDA Submissions (INDs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
• EU REIMBURSEMENT FOR MEDICAL DEVICES
• Including Europe in your Strategy to add value to early-stage Biotech Products
16
• 2009 PDA/FDA Joint Regulatory Conference
• BioBanking 2009
• EU REIMBURSEMENT FOR MEDICAL DEVICES
• BioKorea 2009
• 2nd Annual Lyophilisation Conference
• Essentials of Clinical Study Management
• The CTD/eCTD: Building the Marketing Application throughout Clinical Development
• Improving Investigator Site Performance
• Software Development for Medical Device Professionals
• Dermatological Product Development
• Validation of Computer Systems
• EU REIMBURSEMENT FOR MEDICAL DEVICES

17
• 2009 PDA/FDA Joint Regulatory Conference
• BioBanking 2009
• BioKorea 2009
• 2nd Annual Lyophilisation Conference
• Medical Approach in Diagnosis and Management of ADRs
• Building the eCTD
• Essentials of Clinical Study Management
• Improving Investigator Site Performance
• Software Development for Medical Device Professionals
• Dermatological Product Development
• Validation of Computer Systems
• Microarray Data Analysis Webcast Series: Affymetrix Gene Expression Analysis
18
• 2009 PDA/FDA Joint Regulatory Conference
• BioKorea 2009
• AN OVERVIEW OF THE eCTD - Are you up to date?
• Medical Approach in Diagnosis and Management of ADRs
• Building the eCTD
• Essentials of Clinical Study Management
19

20

21
• EU PAEDIATRIC LEGISLATION - OPPORTUNITES, CHALLENGES AND ROUTES TO SUCCESSFUL COMPLIANCE
• UNDERSTANDING THE LAW ON SUPPLEMENTARY PROTECTION CERTIFICATES
• GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - AN ESSENTIAL OVERVIEW
• Best Practices for an Effective Cleaning Validation Program
• Adverse Drug Events - Reporting & Regulatory Requirements
• Good Laboratory Practices for Pre-Clinical Testing
• Design Control for Medical Device Professionals
• Logipharma 2009
22
• 3rd Bay Area Life Sciences Marketing Strategy Forum
• EU PAEDIATRIC LEGISLATION - OPPORTUNITES, CHALLENGES AND ROUTES TO SUCCESSFUL COMPLIANCE
• DRAFTING EFFECTIVE PHARMACEUTICAL PATENT CLAIMS
• Best Practices for an Effective Cleaning Validation Program
• Adverse Drug Events - Reporting & Regulatory Requirements
• Good Laboratory Practices for Pre-Clinical Testing
• Design Control for Medical Device Professionals
• The EU Clinical Trial Directive
• DRUG / DEVICE AND DEVICE / DRUG COMBINATIONS - Practical Guidance on Borderline Issues and Combination Products
• Logipharma 2009
• Pharmacy - A success story starting to happen
23
• PHARMACEUTICAL ORIGINATION AND ARTWORK
• The EU Clinical Trial Directive
• Good Manufacturing Practices
• The Drug Development Process - From Discovery to Commercialization
• Design Validation, Verification, and Risk Analysis for Medical Device Professionals
• Process Validation for Drugs and Biologics
• BIOTECHNOLOGY FOR THE NON-BIOTECHNOLOGIST
• SUCCESSFUL MEDICAL WRITING
• DRUG / DEVICE AND DEVICE / DRUG COMBINATIONS - Practical Guidance on Borderline Issues and Combination Products
• Logipharma 2009
24
• PHARMACEUTICAL ORIGINATION AND ARTWORK
• The 3rd Annual Pain Therapeutics Summit
• Market & Patient Access For Chronic Disease Therapies
• THE CLINICAL OVERVIEW AND CLINICAL SUMMARY: CREATING AN EFFECTIVE MARKETING AUTHORISATION APPLICATION
• Good Manufacturing Practices
• The Drug Development Process - From Discovery to Commercialization
• Design Validation, Verification, and Risk Analysis for Medical Device Professionals
• Process Validation for Drugs and Biologics
• Clinical Trials Design for Medical Devices
• European Filing & Registration Procedures
• BIOTECHNOLOGY FOR THE NON-BIOTECHNOLOGIST
• SUCCESSFUL MEDICAL WRITING
• Optimal Cold Chain Management through North American Distribution Networks
25
• The 3rd Annual Pain Therapeutics Summit
• Market & Patient Access For Chronic Disease Therapies
• Good Manufacturing Practices
• The Drug Development Process - From Discovery to Commercialization
• Clinical Trials Design for Medical Devices
• European Filing & Registration Procedures
• BIOTECHNOLOGY FOR THE NON-BIOTECHNOLOGIST
• SUCCESSFUL MEDICAL WRITING

26

27

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• THE MEDICAL DEVICE AUTUMN SCHOOL: - 5 Day Residential Course - Boston, USA - From Concept to Market
• ADVANCED PHARMACOVIGILANCE
• Periodic Safety Update Reports - A 2 Day Practical Meeting
29
• 3rd Smoking Cessation Conference
• THE MEDICAL DEVICE AUTUMN SCHOOL: - 5 Day Residential Course - Boston, USA - From Concept to Market
• ADVANCED PHARMACOVIGILANCE
• RISK MANAGEMENT - Applying it and meeting the Challenges for Industry
• Periodic Safety Update Reports - A 2 Day Practical Meeting
• The role of pharmacy in the management of depression
30
• STRATUM CORNEUM VI - RESIDENTIAL COURSE
• Outsourcing in Clinical Trials East Coast
• 3rd Smoking Cessation Conference
• THE MEDICAL DEVICE AUTUMN SCHOOL: - 5 Day Residential Course - Boston, USA - From Concept to Market
• ADVANCED PHARMACOVIGILANCE
• RISK MANAGEMENT - Applying it and meeting the Challenges for Industry
• Microarray Data Analysis Webcast Series: 2-Channel Gene Expression Analysis
1
• PHARMACOKINETICS - Workshop for Beginners
• STRATUM CORNEUM VI - RESIDENTIAL COURSE
• Prefilled Syringes 2009
• THE MEDICAL DEVICE AUTUMN SCHOOL: - 5 Day Residential Course - Boston, USA - From Concept to Market
• Practical Methods for Project Management
• Quality System Regulation for the Medical Device & Biotech Industries
2
• PHARMACOKINETICS - Workshop for Beginners
• STRATUM CORNEUM VI - RESIDENTIAL COURSE
• Prefilled Syringes 2009
• THE MEDICAL DEVICE AUTUMN SCHOOL: - 5 Day Residential Course - Boston, USA - From Concept to Market
• Practical Methods for Project Management
• Quality System Regulation for the Medical Device & Biotech Industries
3

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