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Nov 2009

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Thu, Nov 26, 2009

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Wed, Dec 2, 2009		Cleantech Forum XXV- Beijing - Conference (Grand Hyatt Beijing; Beijing, China) Theme: The largest cleantech market goes from niche to mainstream Connect with clean technology leaders from around the world at the longest-running clean technology event series. Cleantech Forum XXV on December 2-3, 2009 in Beijing is one of five international Cleantech Forums, convening 500 global clean technology leaders representing trillions in capital while providing insight into cleantech trends, and investment opportunities. Meet the power players who are still investing, still creating jobs and wealth, stimulating global economic growth during uncertain economic times, driving clean technology market expansion and developing new relationships with government. Attendees have access to plenary sessions, parallel tracks, expert panels, CEO presentations, side programs and an array of informal networking opportunities. Join them at the must-attend China clean technology event of the year. Receive $100 off registration when using promotion code calenderchn09
Thu, Dec 3, 2009 9:00am		ADVANCED CLINICAL PROJECT MANAGEMENT - 2-Day workshop by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110) This course is designed for pharmaceutical and biotech professionals responsible for managing projects. It will explore some of the more challenging issues of project management and assumes that attendees have some prior knowledge in this area. Through the use of lectures, discussions and hands-on workshops, the instructor will teach about different approaches for maximizing the efficiency at which clinical trials are run while at the same time minimizing risk. Who will benefit: This course will be beneficial to clinical project managers who have an understanding of project management basics as well as those with project management experience but limited exposure to the pharmaceutical or biotech industries. Managers with a fundamental understanding of project management as well as clinical and drug development staff involved with clinical trials programs will also benefit. Key topics: * Achievement of corporate goals * Design of clinical trials * Project management resourcing * Risk mitigation * Identification of best practices * Process improvement * Investigator site metrics * Study enrollment * International sites * Institutional Review Board (IRB) Characteristics Learning outcomes: * Understanding the need for risk assessment * Consideration of strategic decisions in project management * Comprehension of trial design decisions * Understanding of how and why to determine best practices * Awareness of why resource planning is critical to project success * Recognition of the importance of teamwork * Strategies for improving site selection and patient recruitment For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Fri, Dec 4, 2009		THE EU COSMETICS DIRECTIVE AND THE NEW COSMETICS REGULATIONS - Course / Training / Workshop (The Rembrandt Hotel, London) A quick examination of the cosmetic products sold in many European shops will pick up a significant number of products that do not comply with the EU Cosmetic Regulations. This demonstrates that there are many companies who do not understand the requirements. The EU has recently stated that they wish to enforce labelling requirements more vigorously and there are heavy fines for infringements. It is easy for the authorities to walk round any shop selling cosmetics and look at the labels. Even a minor infringement could lead to a time consuming investigation. Although very complex and lengthy, the regulations are actually quite straightforward if they are summarised, explained properly and put into context. The object of this seminar is to do just this in thorough but simple terms. You will learn what the EU Cosmetics Directive is, how to understand and comply with it.
Fri, Dec 4, 2009 9:00am		ADVANCED CLINICAL PROJECT MANAGEMENT - 2-Day workshop by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110) This course is designed for pharmaceutical and biotech professionals responsible for managing projects. It will explore some of the more challenging issues of project management and assumes that attendees have some prior knowledge in this area. Through the use of lectures, discussions and hands-on workshops, the instructor will teach about different approaches for maximizing the efficiency at which clinical trials are run while at the same time minimizing risk. Who will benefit: This course will be beneficial to clinical project managers who have an understanding of project management basics as well as those with project management experience but limited exposure to the pharmaceutical or biotech industries. Managers with a fundamental understanding of project management as well as clinical and drug development staff involved with clinical trials programs will also benefit. Key topics: * Achievement of corporate goals * Design of clinical trials * Project management resourcing * Risk mitigation * Identification of best practices * Process improvement * Investigator site metrics * Study enrollment * International sites * Institutional Review Board (IRB) Characteristics Learning outcomes: * Understanding the need for risk assessment * Consideration of strategic decisions in project management * Comprehension of trial design decisions * Understanding of how and why to determine best practices * Awareness of why resource planning is critical to project success * Recognition of the importance of teamwork * Strategies for improving site selection and patient recruitment For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Mon, Dec 7, 2009		Vaccine Technology 2009 Conference - Conference (BSG House, London, UK) With more targets, more investment and more oppportunity than ever, vaccine technology is among the most dynamic in biomedicine today. Advances in reverse vaccinology, computer-aided biotechnology and disposable technologies are revolutionising R&D for infectious disease, paediatric and cancer therapies. Allied with new developments in formualtion, informatics and process development, the market will see growth of over 300% between 2009 and 2023.
Mon, Dec 7, 2009		Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009		Vaccine Technology 2009 Conference - Conference (BSG House, London, UK) With more targets, more investment and more oppportunity than ever, vaccine technology is among the most dynamic in biomedicine today. Advances in reverse vaccinology, computer-aided biotechnology and disposable technologies are revolutionising R&D for infectious disease, paediatric and cancer therapies. Allied with new developments in formualtion, informatics and process development, the market will see growth of over 300% between 2009 and 2023.
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		Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009		EFFECTIVE FAILURE INVESTIGATION - Course / Training / Workshop (Harrington Hall Hotel, London)
Wed, Dec 9, 2009		Reporting Failure Investigations and Process Deviations - Course / Training / Workshop (Malvern, PA)
Wed, Dec 9, 2009		EFFECTIVE FAILURE INVESTIGATION - Course / Training / Workshop (Harrington Hall Hotel, London)
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.
Tue, Jan 12, 2010 9:00pm		Biotech Showcase 2010 - Conference Biotech Showcase is a forum devoted to providing biotechnology companies, investors and pharmaceutical executives with an opportunity to meet in one place during the course of one of the largest annual healthcare investor conference that attracts investors and biopharmaceutical executives from around the world. Now in its second year, the event will expand to a second day and include public biotech companies. The two-day program will feature multiple tracks of presenting companies, plenary sessions, an opportunity to schedule one-to-one partnering meetings and networking. The attendees for the showcase will include private and public equity investors, analysts, bankers, biopharmaceutical industry executives and other industry professionals. The Biotech Showcase is produced by Demy-Colton Life Science Advisors and EBD Group. Both organizations have a long history of providing high quality business support services to the biotechnology industry.
Wed, Jan 13, 2010 9:00pm		Biotech Showcase 2010 - Conference Biotech Showcase is a forum devoted to providing biotechnology companies, investors and pharmaceutical executives with an opportunity to meet in one place during the course of one of the largest annual healthcare investor conference that attracts investors and biopharmaceutical executives from around the world. Now in its second year, the event will expand to a second day and include public biotech companies. The two-day program will feature multiple tracks of presenting companies, plenary sessions, an opportunity to schedule one-to-one partnering meetings and networking. The attendees for the showcase will include private and public equity investors, analysts, bankers, biopharmaceutical industry executives and other industry professionals. The Biotech Showcase is produced by Demy-Colton Life Science Advisors and EBD Group. Both organizations have a long history of providing high quality business support services to the biotechnology industry.
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
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 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)

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