Building a Successful Relationship with the US FDA: Key Step
Overview:
Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.
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.
Why should you Attend: The FDA and other regulatory agencies produce numerous guidance 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:
- Formulation Managers and Scientists
- Project Managers
- Pharmacokineticists
- Clinical Research Scientists (CRS) and Associates (CRA)