2-day In-person Seminar: Preparing IND Submissions for Conventional and Orphan Products

 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. For special situation such as orphan products additional considerations might apply regarding all aspects of the IND from protocol design to the background preclinical data and details of manufacturing information. Failure to submit a satisfactory IND could lead to FDA imposing a clinical hold on the clinical trial in turn adding additional expense and delay to a clinical trial.

Attending this workshop is a good step toward making sure that your next IND meets FDA requirements and gets a “Safe to Proceed” letter from the FDA within 30 days from submission. Also discussed will be special situations such as INDs for orphan drugs and botanical drugs. The session topics are arranged in a logical chronology to ease the understanding of complex issues and possible solutions. This workshop contains a collection of practical tips from the trainer’s extensive IND submission experience.

Who will Benefit:

•  Sponsors of INDs
• Orphan drug developers
• Supervisors, and lead workers in Regulatory Affairs
• Project management personnel
• Senior management executives (CEO, COO, CFO, etc)
• Manufacturing managers, supervisors & personnel
• Clinical and preclinical laboratory managers
• People investing in FDA-regulated product development projects

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. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.