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Webinar Description:

Areas Covered in the Session :
Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol
If you are involved in writing a clinical trial protocol, this seminar will provide
valuable suggestions about various aspects of a clinical protocol from initial synopsis to
various elements of the protocol, role of various personnel in finalizing the protocol, and
troubleshooting common issues. The basic elements of a clinical trial protocol, the dos and
donts of clinical trial procedures, development of a new protocol, amending protocols,
scientific and ethical review of clinical protocols will be discussed.

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.

The overall structure of a protocol and regulatory requirements
Identify who contributes to the protocol development and amendments
The element of a protocol such a background scientific rationale, design
(single blind, double blind, randomized, etc.), primary and secondaryendpoints,
inclusion/exclusion criteria, the Schedule of Events, adverse
event management,
statistical parameters, informed consent, and study synopsis
Practical issues with protocol writing such a differences in various phases of
clinical trials,
the protocol review process, using key opinion leaders, and using public
resources and templates
Common issues with FDA and IRB approval of clinical protocols.


Product

FDB1108
Category Food, Drugs & Biologics
Duration Thursday, June 12, 2014 at 13:00 Hrs
Speaker Mukesh Kumar
Regulatory Affairs Professionals

Sponsors of INDs

Senior Management Executives (CEO, COO, CFO, etc)

Drug Discovery and Development Professionals (R&D and CMC)

Clinical Trial Managers

Project Managers and Clinical Trial Specialists

Regulatory Compliance Associates and Managers

People Investing in FDA-Regulated Product Development Projects
Speaker Profile:



Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and
quality assurance for manufacturers and developers of FDA-regulated products.
He and 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
multinational project management for medicinal and diagnostic products.

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.
Who Will Benefit:
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