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March 2010
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Mar 2010
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Tue, Nov 24, 2009


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28
• The international conference on Early Disease Detection and Prevention (EDDP)
• Pittcon 2010 Conference and Exposition
1
• euroPLX 42 Valletta
• Adverse Drug Events - Reporting & Regulatory Requirements
• Good Clinical Practice for Medical Device Investigations
• Biostatistics for Non-Statisticians
• Pittcon 2010 Conference and Exposition
2
• euroPLX 42 Valletta
• Adverse Drug Events - Reporting & Regulatory Requirements
• Good Clinical Practice for Medical Device Investigations
• Biostatistics for Non-Statisticians
• Stability Programs for Product Shelf Life - From Development to Approval
• Pittcon 2010 Conference and Exposition
3
• Biostatistics for Non-Statisticians
• Stability Programs for Product Shelf Life - From Development to Approval
• Good Clinical Practice Auditing
• The Drug Development Process - From Discovery to Commercialization
• Pittcon 2010 Conference and Exposition
4
• Good Clinical Practice Auditing
• The Drug Development Process - From Discovery to Commercialization
• Pittcon 2010 Conference and Exposition
5
• Regulatory T cells in inflammatory and infectious diseases: new horizons for old friends
• The Drug Development Process - From Discovery to Commercialization
• Pittcon 2010 Conference and Exposition
6

7

8
• Introduction to Molecular Biology Techniques
• Good Clinical Practices (GCP)
• Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
• BIO-Europe Spring 2010
9
• Introduction to Molecular Biology Techniques
• Good Clinical Practices (GCP)
• Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
• The EU Clinical Trial Directive
• How to Prepare for a Systems-based Inspection - Understanding FDA's Risk-based Inspections Approach
• BIO-Europe Spring 2010
10
• SUCCESSFUL MEDICAL WRITING
• Good Clinical Practices (GCP)
• The EU Clinical Trial Directive
• How to Prepare for a Systems-based Inspection - Understanding FDA's Risk-based Inspections Approach
• The CTD/eCTD: Building the Marketing Application throughout Clinical Development
• BIO-Europe Spring 2010
11
• SUCCESSFUL MEDICAL WRITING
• The CTD/eCTD: Building the Marketing Application throughout Clinical Development
• Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
• How to Develop an Effective Complaint Handling, and Post Market Surveillance Program for Drugs & Devices
• European Filing & Registration Procedures
12
• SUCCESSFUL MEDICAL WRITING
• Recombinant vaccines - right molecule, right place, right time?
• The CTD/eCTD: Building the Marketing Application throughout Clinical Development
• Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
• How to Develop an Effective Complaint Handling, and Post Market Surveillance Program for Drugs & Devices
• European Filing & Registration Procedures
13

14

15
• Preparing the CMC Section for NDAs/CTDs/INDs
• Cleanroom Microbiology for the Non-Microbiologist
• Labeling and Labeling Controls for Medical Devices
• Clinical Trials Design for Medical Devices
• Validation of Computer Systems
16
• Pharma & Biotech Supply Chain Asia 2010
• Preparing the CMC Section for NDAs/CTDs/INDs
• Cleanroom Microbiology for the Non-Microbiologist
• Labeling and Labeling Controls for Medical Devices
• Clinical Trials Design for Medical Devices
• Validation of Computer Systems
17
• Pharma & Biotech Supply Chain Asia 2010
• Technical Writing for Pharmaceutical, Medical Device and Biotech Industries
• Sterilization Procedures: Technology, Equipment & Validation
• Purchasing Controls in the Medical Device Industry
18
• Pharma & Biotech Supply Chain Asia 2010
• Technical Writing for Pharmaceutical, Medical Device and Biotech Industries
• Sterilization Procedures: Technology, Equipment & Validation
• Purchasing Controls in the Medical Device Industry
19
• Pharma & Biotech Supply Chain Asia 2010
• Technical Writing for Pharmaceutical, Medical Device and Biotech Industries
20

21

22
• INJECTABLE DRUG DELIVERY - Devices, Technology & Development - **Formerly NEEDLE-FREE, PEN AND AUTO INJECTORS**
• Overview of FDA Regulatory Compliance for Medical Devices
• Project Management for Phase 1 & 2 Clinical Trials
• Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
• Pharmaceutical Production Batch Record Review
23
• INJECTABLE DRUG DELIVERY - Devices, Technology & Development - **Formerly NEEDLE-FREE, PEN AND AUTO INJECTORS**
• Overview of FDA Regulatory Compliance for Medical Devices
• Project Management for Phase 1 & 2 Clinical Trials
• Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
• Pharmaceutical Production Batch Record Review
24
• Root Cause Analysis for CAPA
• Optimization of Drug-Like Properties in Drug Discovery - Assessment and Structure Modification Strategies
• Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
25
• Root Cause Analysis for CAPA
• Optimization of Drug-Like Properties in Drug Discovery - Assessment and Structure Modification Strategies
• Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
26
• Root Cause Analysis for CAPA
• Optimization of Drug-Like Properties in Drug Discovery - Assessment and Structure Modification Strategies
27

28

29
• Effective Quality Assurance Auditing for FDA Regulated Industries
• Selecting and Managing CRO's
30
• Translational Regenerative Medicine Conference
• Selecting and Managing CRO's
31
• Translational Regenerative Medicine Conference
• Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities

1
• Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities

2

3

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