ComplianceOnline

Meeting the FDA: How to get the best advice from the FDA

Instructor: Mukesh Kumar
Product ID: 701800
  • Duration: 60 Min

recorded version

$299.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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Read Frequently Asked Questions

Understand how to prepare for FDA meeting before formally submitting the marketing application, what are do’s and don’ts and what are possible solutions for a successful FDA meeting.

Why Should You Attend:

The ultimate goal of any product development is successful approval by the FDA. Since FDA makes the final decision if the information provided in a given marketing application is sufficient to approve or reject, it makes a lot of sense to discuss the contents with the FDA reviewer prior to submitting the formal application and FDA encourages it so that sponsors can become aware of FDA’s concerns and it will help the applicant trouble-shoot issues before formal submission of data.

Periodic and timely discussions with the FDA have been shown to exponentially increase the probability of the rapid market approval for a given product. The webinar training will discuss the dos and don’ts of FDA meetings describing common mistakes and possible solutions using real-life case studies. Techniques in preparing for FDA meetings, from the initial request to close-out of discussions post-meeting will be described. Attend this webinar to learning how to make the most of meetings with FDA to achieve timely and cost-effective product development.

Areas Covered in the Seminar:

  • Types of FDA meetings.
  • Key guidelines available from FDA.
  • Preparing the meeting request.
  • Preparing for the actual meeting.
  • FDA’s review process and sponsor consultation.
  • Logistics of the FDA meeting.
  • Follow-up to an FDA meeting.
  • Do’s and don’ts of an FDA meeting.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Project Managers
  • Clinical trial specialists
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects

Instructor Profile:

Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India.

He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Back Ground:

Formal meetings with the reviewers of the US Food and Drug Administration (FDA) are perhaps one of the most important and useful resource available to the sponsors of medicinal products looking to get marketing approval in the US. FDA personnel participate in hundreds of meetings each year with applicants for all kinds of applications submitted to the FDA. These FDA meetings provide an opportunity to the industry to discuss product development strategies with the regulators and clarify interpretations of the regulations.

The ultimate goal of any product development is successful approval by the FDA. A given product could take up to 10 years and cost hundreds of millions of dollars before being ready for formal review by the FDA in a marketing application. For any product a sponsor needs to demonstrate safety, efficacy and consistency using a series of tests and process developments such as animal experiments, clinical trials, and optimizing the manufacturing steps. Moreover, each product has unique requirements for testing based on the scientific criteria to establish significant benefit over the risk of consumption.

Since FDA makes the final decision if the information provided in a given application is sufficient to approve or reject, it makes a lot of sense to discuss the contents with the FDA reviewer prior to submitting the formal application. One can get direct feedback from the FDA reviewers about the appropriateness of the proposed tests (animal and clinical trials), sufficiency of data and adequacy of the format in which the information is proposed to be presented. Sponsors can become aware of the FDA’s concerns and opinions about all the tasks planned and completed, and help the applicant trouble-shoot issues before formal submission of data. The feedback obtained from the FDA reviewers could potentially help avoid pitfalls and preempt issues leading to higher probability of successful application.

FDA strongly recommends that the sponsor requests meeting with its reviewers as many times as needed and as early in development process as possible. FDA has released a few guidance documents to help sponsors prepare for these meetings and also published analysis by independent organizations highlighting the importance of pre-submission meetings with the FDA in getting faster and favorable response from the Agency. Periodic and timely discussions with the FDA have been shown to exponentially increase the probability of the rapid market approval for a given product. It has also been shown that most applications rejected by the FDA involved issues that could have been addressed relatively easily, with less time and cost, had the sponsors asked the right questions of the FDA reviewers.

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