Live Webinar April 15th, 2014 12:00 am – 1:00 pm EDT
Duration:  1 Hour  Credits: 1 PDU/CDU  Cat B – Free PDU/CDU
Presented by: IIBA    Pharma/Biotech SIG

This webinar will focus on the three main areas that comprise pharmaceutical R&D:

1. The Beginning of Basic Discovery: Identifying a Disease process (What’s wrong?)
2. Preclinical Development and Phase I trials: What the drug does to the body? What does the body do to the drug? (Toxicology and Safety)
3. Clinical Development: Clinical trials to determine drug safety in humans. (Effectiveness/Safety Regulations)

Part one covers the various aspects of basic research. This sets the stage for discussing the purpose of preclinical development and describing what that entails.

The goal is to demystify each step in the process for the non-scientist.

Lastly, there are certain regulations and guidelines that govern human clinical trials to ensure drug safety in larger populations, clinical development.

For those who would like to learn more about the Pharma/Biotech R&D domain, this introduction will provide an overview of the high level processes from the lab to the clinic.

Presenter: Aubrey Watkins III, Ph.D. (LinkedIn profile), is Associate Director, Global Procurement, at Merck Sharp & Dohme, and is responsible for establishing contracts and managing over $100M of business with suppliers on a global basis in support of pre-clinical research and manufacturing of vaccines and biologics for Phase I trials.

PDU Category C (PMBOK 5) documentation details:

Process Groups: Planning

Knowledge Areas: 4 – Integration

• 4.1 Develop Project Charter
• 4.2 Develop Project Management Plan

As a Category C ‘Self Directed Learning Activity’ remember to document your learning experience and its relationship to project management for your ‘PDU Audit Trail Folder’

Click to register for IIBA: Pharmaceutical Research and Development: From Discovery to Approval