The Drug Development Process - From R&D to Commercialization

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The Drug Development Process - From R&D to Commercialization


Course "The Drug Development Process - From R&D to
Commercialization" has been pre-approved by RAPS as eligible

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for up to 1.00 credits towards a participant's RAC recertification
upon full completion.
Date & Time:
Instructor Profile:
Thursday, July 12, 2012
10:00 AM PDT | 01:00 PM EDT
Amnon Eylath
Duration: 60 Minutes
Instructor: Amnon Eylath
Director Global Quality, Ariad
Pharmaceuticals
Location: Online
Price : $245.00 (for one participant)
Amnon Eylath is Director of Quality
at Ariad in Cambridge,
Overview:
Massachusetts. He is responsible for
In today's fast-paced, highly regulated and risk-aversive
global oversight of the QA/QC
environment, functional groups can no longer work in isolation, but
aspects of Drug Substance and Drug
must collaborate extensively to design, develop, manufacture, test,
Product Manufacturing, Testing,
Stability, Packaging and Distribution,
validate and commercialize new drugs. Successful commercialization
as well as oversight of compliance
depends on effective processes to bring both the drug supply
for Pre-Clinical (GLP) and Clinical
manufacturing processes and controls as well as the associated data
(GCP) Studies. Amnon has over 20
and knowledge to the levels required for an approvable launch.
years of experience in medical
research, process & method
An overview of the drug development process, reviewing key
development, device development,
deliverables for each stage of the development path with a special
facility/process design and
focus on managing the development process when using external
validation, GxP audits and regulatory
compliance, CMC support,
resources such as Contract Manufactures, Contract Testing Labs and
development and deployment of
Contract Research Organizations.
quality systems, as well as
disposition of Biotech and Small
Why Should You Attend:
Molecule clinical materials for US and
international use. ...more
How familiar are you with the complex and cross-functional activities
that make up the drug development path? If you are involved in any
step of drug development from discovery research through process
Suggest a Topic
More Webinars
development, pre-clinical and toxicological testing, GMP
manufacturing, clinical trials and regulatory affairs, an understanding

Your Necessity is our Priority
of how your role fits in with the other activities is key to achieving
effective and efficient development and commercialization.
Areas Covered in the Session:

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The transition from discovery to development
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The purpose of Pre-clinical studies
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The four major clinical phases (1-4) in the drug development
process and the rationale for each with key deliverables
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Milestones on The "Dual Path" to Drug Commercialization
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Where do IND and NDA fit into the process
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Overview of the key government regulations that impact the
development process (Code of Federal Regulations and ICH)
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Designing the drug with the patient and regulations in mind
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The criticality of effective project management for cross-
functional teams during the development process with special
focus on managing activities performed by contract
manufactures, labs and suppliers
Click here to register for this webinar
Who Will Benefit:
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Research & development scientists
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Clinical monitors and research associates
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Medical and clinical investigators and study coordinators
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Statisticians & data management professionals
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CMC/pharmaceutical research professionals
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Regulatory Affairs Professionals
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Project Managers
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Senior sales managers
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Analytical Development

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Program Management
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
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