Developing a Healthy Relationship with FDA

MessageThis Webinar is over
Date May 20, 2014
Time 10:00am
Cost $195.00
Online
Overview:
A brief description of the FDA groups that are responsible for approving new drug products is reviewed including how one group works with another. This webinar will describe how drug development works in a pharmaceutical company for those students who do not have this experience. The common steps that companies take to develop drugs are described along with documents that are required along this journey. The logistics of interacting with the FDA are described including what the company needs to accomplish to be successful at the meeting. 

When the company’s early development group has basic information that indicates that the chemical may have what it takes to be a drug, the company contacts the FDA to begin the drug development process. The interaction begins and ends with documents that are prepared for review of the testing that has occurred. These interactions can be phone calls, written mailings, and/or face-to-face meetings. Along the way there are intermediate documents that the FDA needs to review before the company can proceed to the next step. These include the Investigational New Drug application (IND), end of Phase I document, end of Phase II document, and New Drug Application (NDA). Along the way the company provides the Agency with a development plan and protocols or protocol outlines for review. The protocols are provided to individual clinical investigators for review to determine if they can run the study effectively and obtain needed clinical results. When the study is completed, a clinical report is developed to provide the results of the study and an interpretation of what the data mean. 

The ability to prepare for a productive meeting with the FDA requires significant time and effort from the company. The team extensively prepares for the meeting weeks before the presentation. We will review what is done to make for a successful interaction with the FDA. 

Why should you attend: 
The FDA and other regulatory agencies produce numerous guidances on specific topics that are very helpful. However, there are other issues that can interfere with the developmental process. This presentation will identify these potential problems and recommend how to address them. The areas covered will include: stages of drug development, company teams for developing a drug, relevant structure of the FDA, process of contacting the FDA, important milestone meetings and documents, preparation for meetings, resolve potential issues, and logistics. 

This webinar should be "required reading" for those who want to be a member of a drug project team and any of the sub-teams. The first step in the drug development approval process is knowing what needs to be done. When the company starts interacting with the FDA, knowing the steps that are required will likely give the FDA some initial confidence of the proposed plan. 
Areas Covered in the Session:
  • Organization of the FDA
  • Stages in drug development
  • Important meetings with the FDA
  • Logistics of regulatory meetings
  • Content of protocols and clinical reports
  • Outline of IND and NDA application
Who Will Benefit:
  • Senior Scientists
  • Clinical Research Associates
  • Clinical Research Scientists
  • Managers
  • Medical Doctors
  • Directors

 


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