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 for up to 1.00 credits towards a participant's RAC recertification upon full completion.
Date & Time:
Thursday, July 12, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Amnon Eylath
Price : $245.00
Amnon Eylath Director Global Quality, Ariad Pharmaceuticals
(for one participant)
Overview: In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and knowledge to the levels required for an approvable launch. An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations.
Why Should You Attend: 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 development, pre-clinical and toxicological testing, GMP manufacturing, clinical trials and regulatory affairs, an understanding of how your role fits in with the other activities is key to achieving effective and efficient development and commercialization.
Amnon Eylath is Director of Quality at Ariad in Cambridge, Massachusetts. He is responsible for global oversight of the QA/QC aspects of Drug Substance and Drug Product Manufacturing, Testing, Stability, Packaging and Distribution, as well as oversight of compliance for Pre-Clinical (GLP) and Clinical (GCP) Studies. Amnon has over 20 years of experience in medical research, process & method development, device development, facility/process design and validation, GxP audits and regulatory compliance, CMC support, development and deployment of quality systems, as well as disposition of Biotech and Small Molecule clinical materials for US and international use. ...more
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Areas Covered in the Session: l
The transition from discovery to development
The purpose of Pre-clinical studies The four major clinical phases (1-4) in the drug development process and the rationale for each with key deliverables Milestones on The "Dual Path" to Drug Commercialization
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Where do IND and NDA fit into the process Overview of the key government regulations that impact the development process (Code of Federal Regulations and ICH) Designing the drug with the patient and regulations in mind The criticality of effective project management for crossfunctional 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: l l l l l
Research & development scientists Clinical monitors and research associates Medical and clinical investigators and study coordinators Statisticians & data management professionals CMC/pharmaceutical research professionals
Regulatory Affairs Professionals Project Managers Senior sales managers
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