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10430 Overview of Drug Development
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Title:
Overview of Drug Development


Date(s) And Time(s):
Dec 8 2010 8:30AM - Dec 8 2010 4:45PM

Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Interest Area(s):
Professional Education, Training & Development,Clinical Research,Medical Writing,Project Management

Overview:

Proven Tips to Identify and Develop Pharmaceutical Products

 

Participate in interactive discussions on how to develop drugs and biologics under FDA and ICH Guidelines while proactively overcoming any drug development challenges.


WHAT YOU WILL LEARN
• How the pharmaceutical industry identifies new products and brings them to market
• Contributions of key groups within the company and how they interact
•  FDA and regulation of the industry
•  The basics of filing a New Drug Application (NDA)
•  Ethical considerations in conducting clinical research
•  Institutional review, informed consent, and financial disclosure
•  Concepts and functions associated with ensuring overall study quality



Learning Objectives:

At the conclusion of this course, participants should be able to:

  • Recognize the process of discovering and developing new pharmaceutical products
  • Describe the activities associated with conducting clinical research and reporting the results and responsibilities of various departments in accomplishing these activities
  • Discuss institutional review, informed consent, and financial disclosure
  • Develop knowledge about concepts and functions associated with ensuring overall quality of studies
  • Describe the organization of the FDA, their authority, and interactions with sponsor companies


Target Audience:
• Clinical research associates
• Project managers
• Team sponsors
• Regulatory affairs personnel
• Administrative staff
• Study support staff
• Medical writers
• Business support staff


Event Code:
10430

Contact Information:

For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email
Colleen.Buckley@diahome.org

If you have not received confirmation within 5 business days, please contact:
DIA
Tel. +1-215-442-6100
Fax +1-215-442-6199
Email
confirmationservices@diahome.org