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Nov 2009
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Wed, Nov 25, 2009


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Thu, Nov 26, 2009
 MEDICAL DEVICE REGULATORY AFFAIRS IN THE MIDDLE EAST - Seminar (The Rembrandt Hotel, London)
BENEFITS OF ATTENDING THIS MEETING: ■ Stay Ahead of your Competitors by Understanding the Regulatory Requirements and Market Opportunities in this Region ■ Understand the Regulatory Pathways to Medical Device Markets in Israel ■ Discuss the Regulatory Developments in Saudi Arabia and the Gulf States ■ Clarify the Requirements for Medical Devices in Iran ■ Discover the Regulatory Requirements and How to Get Medical Devices on to the Jordanian Market ■ Know How to Gain Access to the Lebanese Market
Mon, Nov 30, 2009
 MEDICAL DEVICE REGULATION IN ASIA PACIFIC - Conference (The Rembrandt Hotel, London)
Overview This seminar will provide a comprehensive overview of the medical device regulations and developments in China, Japan and India together with other newly regulated countries within this geographic region. Take away practical guidance on how to comply with the requirements and gain access to these growing markets. Learn how these requirements are being interpreted and applied and how legislation may change in the future.
Mon, Nov 30, 2009
 Clinical Trials Design for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
Tue, Dec 1, 2009
 MEDICAL DEVICE REGULATION IN ASIA PACIFIC - Conference (The Rembrandt Hotel, London)
Overview This seminar will provide a comprehensive overview of the medical device regulations and developments in China, Japan and India together with other newly regulated countries within this geographic region. Take away practical guidance on how to comply with the requirements and gain access to these growing markets. Learn how these requirements are being interpreted and applied and how legislation may change in the future.
Tue, Dec 1, 2009
 Clinical Trials Design for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
Wed, Dec 2, 2009
 Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009
 Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009
 How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices - Course / Training / Workshop (Malvern, PA)
Fri, Dec 4, 2009
 Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Fri, Dec 4, 2009
 How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices - Course / Training / Workshop (Malvern, PA)
Mon, Dec 7, 2009
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009
 ADVERSE EVENT MANAGEMENT DURING MEDICAL DEVICE CLINICAL STUDIES - Seminar (The Rembrandt Hotel, London, SW7)
BENEFIITS IN ATTENDING: Understand the Significance of the Revision of the MDD In Relation to Adverse Incident Reporting Gain an Overview of the Current System In Europe Keep Abreast with GHTF Progress Know the Role of the Data Safety Monitoring Board Understand the Definitions and Classification of Adverse Events Get an Insight into Competent Authorities Expectations Learn What Happens After CE Marking COURSE OBJECTIVES At the end of the course delegates will be able to:- Explain the regulations governing the monitoring and reporting of adverse events Produce an appropriate adverse event form for use during a study Define and classify adverse events occurring during a study Understand the changes in the regulations and how they impact onadverse event reporting WHO SHOULD ATTEND Those responsible for monitoring medical device clinical studies and those involved in adverse event management and reporting in house and in the field, including; clinical and regulatory staff. Clinical Investigators and clinical site staff who conduct medical device clinical studies and would like to learn more about identifying, interpreting and reportingadverse events during the conduct of a device study. With: Janette Benaddi, Chief Executive Officer, Medvance Ltd.
Tue, Dec 8, 2009
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices - Course / Training / Workshop (Malvern, PA)
Wed, Dec 9, 2009
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices - Course / Training / Workshop (Malvern, PA)
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
 HOW TO AUDIT REGULATORY AFFAIRS & CLINICAL TRIALS - Seminar (The Rembrandt Hotel, London)
**Discount Available if booked with DOCUMENT MANAGEMENT AND ARCHIVING FOR CLINICAL RESEARCH AND REGULATORY AFFAIRS COMPLIANCE - A12-4309 - 10 December 2009** Overview GCP regulations and standards apply to clinical trials of investigational pharmaceuticals, biologics and medical devices. Failure to conform to these requirements may result in concerns about data quality and integrity. This intensive course provides a comprehensive overview of how to carry out GCP audits for regulatory affairs and clinical research activities. It has been specifically designed to develop audit skills in the EU. It will also help ensure that in your audit role you will understand how the audit programme is essential in achieving regulatory GCP compliance. Participants will review the steps involved in preparing for and carrying out GCP audits for Regulatory Affairs and Clinical Trials, including audit checklists and EMEA inspection guidelines for different type of audits, writing the audit report and developing corrective action plans.
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)
Mon, Dec 14, 2009
 Software Development for Medical Device Professionals - Course / Training / Workshop (Malvern, PA)
Tue, Dec 15, 2009
 Overview of FDA Regulatory Compliance For Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Dec 15, 2009
 Software Development for Medical Device Professionals - Course / Training / Workshop (Malvern, PA)
Mon, Jan 4, 2010
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices - Course / Training / Workshop

Tue, Jan 5, 2010
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices - Course / Training / Workshop

Wed, Jan 6, 2010
 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices - Course / Training / Workshop

Thu, Jan 7, 2010
 Good Monitoring Practices for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
Fri, Jan 8, 2010
 Good Monitoring Practices for Medical Devices - Course / Training / Workshop (Costa Mesa, CA)
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
Wed, Jan 20, 2010
 EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London)
WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Wed, Jan 20, 2010
 Process Validation for Medical Devices - Course / Training / Workshop (Malvern, PA)
Thu, Jan 21, 2010
 EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London)
WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Thu, Jan 21, 2010
 Process Validation for Medical Devices - Course / Training / Workshop (Malvern, PA)
Fri, Jan 22, 2010
 Process Validation for Medical Devices - Course / Training / Workshop (Malvern, PA)
Thu, Jan 28, 2010
 MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market - Course / Training / Workshop (The Rembrandt Hotel, London)
Benefits in attending: ■ Understand the affect of regulatory requirements on medical device clinical studies ■ Clarify what is involved in a Clinical Evaluation (Literature Review) ■ Discover how to design pre market and post market studies ■ Know what documentation is needed and what should go in a study master file ■ Discover how to obtain Research Ethics approval in each European Country ■ Plan how to prepare regulatory notifications to the Competent Authorities ■ Understand the key aspects of pre and post market study setup, management, monitoring and close down ■ Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study ■ Discuss how to prepare a paper or presentation for publication and marketing
Fri, Jan 29, 2010
 MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market - Course / Training / Workshop (The Rembrandt Hotel, London)
Benefits in attending: ■ Understand the affect of regulatory requirements on medical device clinical studies ■ Clarify what is involved in a Clinical Evaluation (Literature Review) ■ Discover how to design pre market and post market studies ■ Know what documentation is needed and what should go in a study master file ■ Discover how to obtain Research Ethics approval in each European Country ■ Plan how to prepare regulatory notifications to the Competent Authorities ■ Understand the key aspects of pre and post market study setup, management, monitoring and close down ■ Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study ■ Discuss how to prepare a paper or presentation for publication and marketing
Wed, Feb 3, 2010
 Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries - Course / Training / Workshop (Malvern, PA)
Thu, Feb 4, 2010
 Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries - Course / Training / Workshop (Malvern, PA)
Mon, Feb 22, 2010
 Cost Contained Regulatory Compliance for the Drug, Biologics and Medical Device Industries - Course / Training / Workshop (Malvern, PA)
Tue, Feb 23, 2010
 Cost Contained Regulatory Compliance for the Drug, Biologics and Medical Device Industries - Course / Training / Workshop (Malvern, PA)
Wed, Feb 24, 2010
 Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices - Course / Training / Workshop (Malvern, PA)
Thu, Feb 25, 2010
 Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices - Course / Training / Workshop (Malvern, PA)
Mon, Mar 1, 2010
 Good Clinical Practice for Medical Device Investigations - Course / Training / Workshop (Malvern, PA)
Tue, Mar 2, 2010
 Good Clinical Practice for Medical Device Investigations - Course / Training / Workshop (Malvern, PA)
Thu, Mar 11, 2010
 How to Develop an Effective Complaint Handling, and Post Market Surveillance Program for Drugs & Devices - Course / Training / Workshop (Malvern, PA)
Fri, Mar 12, 2010
 How to Develop an Effective Complaint Handling, and Post Market Surveillance Program for Drugs & Devices - Course / Training / Workshop (Malvern, PA)
Mon, Mar 15, 2010
 Labeling and Labeling Controls for Medical Devices - Course / Training / Workshop (Malvern, PA)
Mon, Mar 15, 2010
 Clinical Trials Design for Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Mar 16, 2010
 Labeling and Labeling Controls for Medical Devices - Course / Training / Workshop (Malvern, PA)
Tue, Mar 16, 2010
 Clinical Trials Design for Medical Devices - Course / Training / Workshop (Malvern, PA)
Wed, Mar 17, 2010
 Technical Writing for Pharmaceutical, Medical Device and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Wed, Mar 17, 2010
 Purchasing Controls in the Medical Device Industry - Course / Training / Workshop (Malvern, PA)
Thu, Mar 18, 2010
 Technical Writing for Pharmaceutical, Medical Device and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Thu, Mar 18, 2010
 Purchasing Controls in the Medical Device Industry - Course / Training / Workshop (Malvern, PA)
Fri, Mar 19, 2010
 Technical Writing for Pharmaceutical, Medical Device and Biotech Industries - Course / Training / Workshop (Malvern, PA)
Mon, Mar 22, 2010
 INJECTABLE DRUG DELIVERY - Devices, Technology & Development - **Formerly NEEDLE-FREE, PEN AND AUTO INJECTORS** - Conference (Hotel to be advised, London)
***Call for Papers*** If you would like to give a presentation at this event please contact andrea.james@Management-forum.co.uk, Further information will be available shortly. Please contact andrea.james@management-forum.co.uk in the meantime.
Mon, Mar 22, 2010
 Overview of FDA Regulatory Compliance for Medical Devices - Course / Training / Workshop (Dublin, Ireland)
Tue, Mar 23, 2010
 INJECTABLE DRUG DELIVERY - Devices, Technology & Development - **Formerly NEEDLE-FREE, PEN AND AUTO INJECTORS** - Conference (Hotel to be advised, London)
***Call for Papers*** If you would like to give a presentation at this event please contact andrea.james@Management-forum.co.uk, Further information will be available shortly. Please contact andrea.james@management-forum.co.uk in the meantime.
Tue, Mar 23, 2010
 Overview of FDA Regulatory Compliance for Medical Devices - Course / Training / Workshop (Dublin, Ireland)



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