Expert Profile
Mukesh Kumar
Senior Director Regulatory Affairs and Quality Assurance,
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.
Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.
Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.
Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".
Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.
Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.
Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".
Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
Live Training by Mukesh Kumar
Medical foods play an important role in the management of patients with special dietary restrictions and needs. The designation of medical food by FDA implies special handling, labeling, distribution and manufacturing requirements.
Live Session
Wednesday,
May 22, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:60
The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). The TMF is a collection of the essential documents to record a site has fulfilled its obligations to the sponsor regarding a clinical trial project.
Live Session
Tuesday,
June 11, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:60
Recorded Training by Mukesh Kumar
Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides basic framework for computer systems used to generate records and data, and used for analysis and presentation.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
Learning how convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
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