Course Description:
Regulatory professionals have to write highly technical documents for a wide audience. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This workshop will address best practices, and regulatory strategies on how to write effective documents spanning everything from simple issues, such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other regulators.
Some of the key takeaways from this seminar will include:
- Practical tips using examples on how to organize and deliver information in clear and readable documents.
- How to edit, format, present and publish technical regulatory documents for most favorable reception by regulatory agencies.
- Rules for writing documents intended for electronic submission to regulatory agencies.
- Technical, practical, logical and logistical tips for all regulatory writers.
Who will Benefit:
- Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
- Medical and technical writers
- Project managers and 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 is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about more than 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia. Dr. Kumar 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 in several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA. |
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