Course Description:
Soon FDA will stop accepting paper submissions of all kinds of applications. Despite there being extensive information available from FDA and other regulatory bodies regarding eCTD submission, creating one and submitting it through the electronic submission gateway (ESG) of the FDA, is a daunting task even for those proficient in computer systems and coding languages. The off-the-shelf software and consultations available are prohibitively expensive not only in the capital investment required but also in terms of the time needed for getting a submission ready.
This 2-day workshop is designed to address all these and provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts. This no-frills workshop aims to train in the minimum skills needed and provide hands-on practical tips to create eCTD submissions. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.
Who will Benefit:
- Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
- Medical and Technical writers
- Project Managers, Directors
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control
- IT professionals looking to make eCTD submissions
Seminar Fee Includes:
Course Outline:
| Day 1 (8:30 AM – 4:30 PM) | Day 2 (8:30 AM – 3:30 PM) | ||
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Meet Your Instructor
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Dr. Mukesh Kumar PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research 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). Mr. Kumar’s 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. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA. |
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