Page 1

Live Webinar


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:



Register Now

Instructor Profile:

Thursday, July 12, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Amnon Eylath

Location: Online

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

Suggest a Topic

More Webinars

Your Necessity is our Priority

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


l l l

l l

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


Analytical Development

l l


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

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

The Drug Development Process - From R&D to Commercialization  

In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collabora...