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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
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Upcoming Training
FDA and US Customs have special requirements for allowing entry of regulated products. Regulated imports could be finished products for sales in the US or raw material or components imported for use in manufacture in the US.FDA-regulated products covered in this webinar include prescription drugs and biologics, medical devices, over the counter drugs, dietary supplements, cosmetics, or medical foods. Importers are required to provide detailed documentation regarding the compliance status of imported material, the country of origin, export documents from the country of origin, the destination in the US, purpose of the import, registration documents, chain of control, and several other elements. Incomplete, inadequate, or erroneous documents are the most common reason for delays in the release or refusal to enter at the US customs.
Live Session  Tuesday, January 20, 2015 10:00 AM PST | 01:00 PM EST,  Duration:60
Recorded Training
Excel spreadsheets are easy and convenient to use for handling common data capture and analysis functions. FDA accepts data in Excel spreadsheets provided it meets the criteria of confidentiality and integrity defined within 21 CFR Part 11, GAMP 5 and related regulations. Excel can be made FDA compliant with simple procedures and practices to meet regulatory requirements. This seminar provide insight into regulatory requirements and inherent limitations in “Out of the Box” Excel, validation techniques, documentation requirements, and risk-based evaluation of Excel spreadsheets. Practical strategies and case studies will be used to highlight common issues and potential solutions.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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. Under the new rules, principal investigators and co-investigators are subject to unprecedented disclosure requirements to the Center for Medicare and Medicaid Services (CMS).
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Computerized manufacturing and quality systems are cited by FDA auditors to be poor in adequate validation leading to FDA 483s, Warning Letters and Consent Decrees.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Companies manufacturing products derived from human cells and tissues for autologous implantation, transplantation, infusion or transfer of human cells and tissues for therapeutic purposes are allowed to market their products without a formal marketing approval under a BLA provided they meet certain conditions that define the permitted good manufacturing and tissue handling practices, labeling and shipping, inter-state commerce and marketing claims. Products that do not meet the strict criteria set by FDA are subject to the IND and BLA regulations before being allowed to market. Recently FDA issued Warning Letters to some companies marketing HCT/Ps citing major modification to human cells and tissues and asked to initiate a formal investigation under an IND and marketing approval. Some products have even been withdrawn from market due to FDA action.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

3D printing offers the promise of easy and convenient custom manufacture of a variety of products. There have been several developments in the use of this technology to manufacture medical devices and even attempts to manufacture biologics and drugs. However, there is no clear direction from FDA regarding the approvability of products manufactured using 3D printing technology. There are some precedent regulatory paradigms available to understand what FDA may consider when regulating 3D printed products.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Mid-way during an ongoing clinical trial, critical information may be anticipated, that could potentially influence the outcome of the entire trial. The trial may benefit enormously if it can be modified to address mid-study new information. A clinical trial design that allows such a modification is called an Adaptive Clinical Trial. Adaptive trials could allow for significant reduction in the cost and time to market for the products under development, and can also increase the probability of success of the development program. Such trials can be employed for all kinds of FDA-regulated products. This seminar will discuss key statistical and regulatory strategies for adaptive clinical trials based of guidance from FDA and case studies.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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. Manufacturers are usually worried about meeting all of FDA's complex requirements for such products. This seminar will discuss the regulatory processes to designate and market a product as medical food. Common issues with FDA compliance will be discussed using case studies and potential solutions will be discussed.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

In the last 4 years the number of FDA warning letter to manufactures of dietary supplement manufacturers have seen a significant increase. Since the implementation of the GMP regulation of dietary supplements in 2007, FDA has conducted numerous audits of manufacturers and suppliers of these products and taken several enforcement actions against products of sub-standard quality, adulterated, false-advertised, or misleading products. To add to that, a vast majority of supplements are imported from manufacturers located in countries with poor GMP requirements for such products.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3 years of market exclusivity available to the approved product.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

The Drug Quality and Security Act (DQSA), signed into law on the 27 Nov 2013, created new rules for the good manufacturing requirements for compounding pharmacies along with registration requirements and safety reporting obligations. These rules bring compounding pharmacies under more vigorous supervision by giving FDA clearer authority to audit such pharmacies while creating a pathway for compounding pharmacies to voluntarily register with the Agency and sign up to be inspected by the FDA under a new category of FDA-regulated facilities called the "Outsourcing Facility".
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

FDA has publicly acknowledged that many regulated products have uses beyond what they have been approved for. FDA also recognizes that these unapproved uses may be beneficial to some patients.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Formal meetings with the reviewers of the US Food and Drug Administration (FDA) are perhaps one of the most important and useful resource available to the sponsors of medicinal products looking to get marketing approval in the US.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

In the last 4 years the number of FDA warning letter to manufactures of dietary supplement manufacturers have seen a significant increase. Since the implementation of the GMP regulation of dietary supplements in 2007, FDA has conducted numerous audits of manufacturers and suppliers of these products and taken several enforcement actions against products of sub-standard quality, adulterated, false-advertised, or misleading products.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Each year FDA audits more than 16,000 facilities involved in manufacture, testing or development of food and drug products, and collects more than 25,000 product samples for analysis at its labs. These include not only drugs and biologics but also medical devices, diagnostic kits, dietary supplements, veterinary products, and animal and clinical testing facilities.
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.

Social media offers an excellent opportunity for a company to get the word out about its drugs, biologics, medical devices and diagnostic kits. However, FDA regulated products need to follow strict information control; any information distributed to consumers must be approved by FDA.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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.

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products.
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.

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.
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.

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This seminar will provide step by step instructions to create SOPs for FDA-regulated organizations.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. However, 505(b)(2) products require evidence from clinical trials conducted under an IND in support of the marketing approval application.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.