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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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July 10, 2012 |
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ComplianceOnline, OnlineEvent
2012-10-19
Why Should You Attend: All sponsors of clinical trials in the US for drug and biologics have to first file an Investigational New Drug (IND) application with the FDA containing extensive information in support of the proposed clinical trial. The IND application contains all available preclinical and clinical testing information, and all manufacturing information for the investigational product, along with clinical protocol, informed consent template, investigator’s brochure and other relevant information. These requirements are particularly tough for sponsors of Phase I and First-in-Man (FIM) clinical trials since these trials are usually planned early on in the development phase with limited preclinical information and may use a preliminary formulation of the investigational product. Agenda:(PDT) - 10.00am PDT to 11.30am (Session 1)
- 11:30am - 12.00 Noon (Break)
- 12.00pm to 1.30pm (Session 2)
Areas Covered in the Seminar: Session 1:
What you must know about an IND: Content and Format of IND sections Session 2: Practical Issues and Potential Solutions for an IND for FIM and Phase I Clinical Trials Who Will Benefit: This Webinar will provide invaluable assistance to the following personnel in the pharmaceutical and biotechnology industry planning to conduct clinical trials under a US IND: - Study sponsors
- Regulatory affairs
- Project management
- Principal investigators and sub investigators
- Clinical research scientists
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Organized by:
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Complianceonline |
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Invited Speakers:
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Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India.
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Deadline for Abstracts:
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2012-10-18
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Registration:
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| $349.00 | One Dial-in One Attendee |
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E-mail:
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referral@complianceonline.com
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