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Nov 2009
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Wed, Nov 25, 2009


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Mon, Nov 30, 2009
 Preparation of FDA Submissions (INDs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA - Course / Training / Workshop (Costa Mesa, CA)
Tue, Dec 1, 2009
 Preparation of FDA Submissions (INDs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA - Course / Training / Workshop (Costa Mesa, CA)
Thu, Dec 10, 2009
 US FDA QUALITY REQUIREMENTS & CAPA FOR MEDICAL DEVICES - Course / Training / Workshop (Hotel to be Advised, London)
FURTHER MEETING DETAILS WILL BE AVAILABLE SHORTLY. Please contact andrea.james@management-forum.co.uk
Fri, Dec 11, 2009
 US FDA QUALITY REQUIREMENTS & CAPA FOR MEDICAL DEVICES - Course / Training / Workshop (Hotel to be Advised, London)
FURTHER MEETING DETAILS WILL BE AVAILABLE SHORTLY. Please contact andrea.james@management-forum.co.uk
Mon, Dec 14, 2009
 Overview of FDA Regulatory Compliance For Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Dec 15, 2009
 Overview of FDA Regulatory Compliance For Medical Devices - Course / Training / Workshop (Malvern, PA)
Mon, Jan 11, 2010
 Effective Quality Assurance Auditing for FDA Regulated Industries - Course / Training / Workshop (Malvern, PA)
Tue, Jan 12, 2010
 Effective Quality Assurance Auditing for FDA Regulated Industries - Course / Training / Workshop (Malvern, PA)
Mon, Jan 18, 2010
 FDA APPROVAL PROCESS FOR MEDICAL DEVICES - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval. Upon completion of this seminar, participants will: Understand the FDA medical device approval system, Know what is required for an Investigational Device Exemption (IDE), Learn the contents of a Post-Market Approval (PMA), Discover what to include in an annual report
Tue, Jan 19, 2010
 FDA APPROVAL PROCESS FOR MEDICAL DEVICES - Course / Training / Workshop (The Rembrandt Hotel, London)
This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval. Upon completion of this seminar, participants will: Understand the FDA medical device approval system, Know what is required for an Investigational Device Exemption (IDE), Learn the contents of a Post-Market Approval (PMA), Discover what to include in an annual report
Mon, Feb 8, 2010
 FDA Inspections of Clinical Data Systems - Course / Training / Workshop (Malvern, PA)
Tue, Feb 9, 2010
 THE US DRUG APPROVAL PROCESS - Course / Training / Workshop (The Cavendish Hotel, London)
General Introduction and important information on FDA Procedures, requirements for marketing authorizations and recent developments affecting the drug approval process Topics covered at this two day meeting: Structure and functions of the FDA ■ Historical background ■ General regulatory requirement ■ Regulation of preclinical and clinical research ■ New drug application process ■ Biologics ■ Special issues ■ Recent legislation, including Food and Drug Administration Amendments Act of 2007 and proposed legislation to govern follow-on biologics With: Richard Kingham - Senior Partner, assigned to the Washington and London offices of Covington & Burling LLP
Tue, Feb 9, 2010
 FDA Inspections of Clinical Data Systems - Course / Training / Workshop (Malvern, PA)
Wed, Feb 10, 2010
 THE US DRUG APPROVAL PROCESS - Course / Training / Workshop (The Cavendish Hotel, London)
General Introduction and important information on FDA Procedures, requirements for marketing authorizations and recent developments affecting the drug approval process Topics covered at this two day meeting: Structure and functions of the FDA ■ Historical background ■ General regulatory requirement ■ Regulation of preclinical and clinical research ■ New drug application process ■ Biologics ■ Special issues ■ Recent legislation, including Food and Drug Administration Amendments Act of 2007 and proposed legislation to govern follow-on biologics With: Richard Kingham - Senior Partner, assigned to the Washington and London offices of Covington & Burling LLP
Mon, Feb 22, 2010
 FDA Inspections - What to Expect and How to Prepare - Course / Training / Workshop (Malvern, PA)
Tue, Feb 23, 2010
 FDA Inspections - What to Expect and How to Prepare - Course / Training / Workshop (Malvern, PA)
Wed, Feb 24, 2010
 Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products - Course / Training / Workshop (Malvern, PA)
Thu, Feb 25, 2010
 Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products - Course / Training / Workshop (Malvern, PA)
Mon, Mar 8, 2010
 Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA - Course / Training / Workshop (Malvern, PA)
Tue, Mar 9, 2010
 Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA - Course / Training / Workshop (Malvern, PA)
Tue, Mar 9, 2010
 How to Prepare for a Systems-based Inspection - Understanding FDA's Risk-based Inspections Approach - Course / Training / Workshop (Malvern, PA)
Wed, Mar 10, 2010
 How to Prepare for a Systems-based Inspection - Understanding FDA's Risk-based Inspections Approach - Course / Training / Workshop (Malvern, PA)
Mon, Mar 22, 2010
 Overview of FDA Regulatory Compliance for Medical Devices - Course / Training / Workshop (Dublin, Ireland)
Tue, Mar 23, 2010
 Overview of FDA Regulatory Compliance for Medical Devices - Course / Training / Workshop (Dublin, Ireland)
Mon, Mar 29, 2010
 Effective Quality Assurance Auditing for FDA Regulated Industries - Course / Training / Workshop (Dublin, Ireland)



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