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Nov 2009
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Mon, Nov 9, 2009


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Thu, Nov 19, 2009
 European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Fri, Nov 20, 2009
 European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne)
This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Mon, Nov 23, 2009
 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application - Conference (Harrington Hall Hotel, London)
The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. Several new parts in the series have been developed which promote a new philosophy of biological evaluation particularly parts 1, 2, 17 and 18. In addition, a major revision of ISO 10993-1 is near completion (FDIS) which incorporates a risk management approach and better co-ordinate the full set of the existing 20 parts in the series. This interactive seminar will provide practical opportunities for the application of these standards and the new approach to biological evaluation.
Tue, Nov 24, 2009
 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application - Conference (Harrington Hall Hotel, London)
The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. Several new parts in the series have been developed which promote a new philosophy of biological evaluation particularly parts 1, 2, 17 and 18. In addition, a major revision of ISO 10993-1 is near completion (FDIS) which incorporates a risk management approach and better co-ordinate the full set of the existing 20 parts in the series. This interactive seminar will provide practical opportunities for the application of these standards and the new approach to biological evaluation.
Tue, Nov 24, 2009
9:00am		 Small Scale Bio-production: Beyond the Flask. - Conference (BioPark Hertfordshire, Welwyn Garden City)
"Once you can produce it in a flask, what next? The focus of this meeting will be on techniques for the bioproduction of usable quantities of biologic materials, specifically recombinant proteins, monoclonal antibodies, cytokines viruses and other secreted cellular products from eukaryotic cells. Topics covered will include expression systems, mammalian vs. insect vs. other, constituitive vs. transient expression, cell culture medium considerations and culture devices for scale-up that can be used in any laboratory. This meeting should show the fastest pathway from discovery to proof of principle and the production of 100 mgs to several grams of product" Meeting Chair: Dr John J.S. Cadwell, President and CEO, FiberCell Systems Inc, USA
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 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
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 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
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.
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.



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