Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol - PowerPoint PPT Presentation

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Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol

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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. – PowerPoint PPT presentation

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Title: Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol


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Contact Us 416-915-4458
We Empower, You Comply!
Webinar On 10 Steps to an FDA-Acceptable
Clinical Trial Protocol
Product FDB1108
Category Food, Drugs Biologics
Duration Thursday, June 12, 2014 at 1300 Hrs
Speaker Mukesh Kumar
To register for this webinar please visit our
website www.compliancetrainings.com
Webinar Description

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.
Areas Covered in the Session
  • 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.

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Who Will Benefit
  • Regulatory Affairs Professionals
  • Sponsors of INDs
  • Senior Management Executives (CEO, COO, CFO,
    etc)
  • Drug Discovery and Development Professionals
    (RD 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.
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