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The Drug Development Path - From R&D to Commercialization - Webinar by GlobalCOmpliancePanel

 
  October 25, 2010  
     
 


GlobalCompliancePanel, USA
2010-11-18


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.

Why you should 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.

Areas Covered In the Seminar:
  • 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
  • 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 cross-functional teams during the development process with special focus on managing activities performed by contract manufactures, labs and suppliers
Who will benefit:
  • 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
  • Analytical Development
  • Program Management
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: Amnon Eylath: - 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.

Amnon is currently is leading the development of a technical report on the application of cGMP and Quality Systems for the complete development life-cycle of Biotech Drug Substance, in collaboration with industry and regulatory agency representatives. He is also a core member of industry Task Forces developing technical reports for application of GMPs to Investigational Medicinal Product, Development of Specifications for Early Phase drug development and Risk-Based auditing. He has recently commented to changes in Eudralex regulations covering drug development. He has also lectured at Moorpark College, UC Davis and Indiana University on Quality and Pharmaceutical Technology subjects, and was instrumental in the establishment of the Biotechnology certification and degree programs (respectively) at Moorpark College and Indiana University.
 
Deadline for Abstracts: 2010-12-09
 
Registration:
Thursday, November 18, 2010  
10:00 AM PDT | 01:00 PM EDT
Live live online training only for one participant
Price: $245.00
 
 
 
Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
Price: $995.00
 

E-mail: webinars@GlobalCompliancePanel.com
 
   
 
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