Webinars >>EMA Regulations
How to Prepare for a Meeting with EMA and Other European Regulatory Agencies for Drugs and Biologics
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Europe is an attractive market for drugs and biologics. Formal meetings with the reviewers at the European Medicines Agency (EMA) and regulators at the Notified Bodies (NB) at European nations are perhaps one of the most important and useful resource available to the sponsors of medicinal products looking to get marketing approval in the Europe. EMA and other regulatory personnel participate in hundreds of meetings each year with applicants for all kinds of applications submitted to them for review. These meetings provide an opportunity to the industry to discuss product development strategies with the regulators and clarify interpretations of the regulations. Unlike US FDA, there are very few guidance documents to help companies prepare for meetings with the EMA and NB. European processes for meeting the regulators are vastly different from those at the US FDA and any other regulatory agencies in other parts of the World. Applicants need to understand the types of meetings, scope of each meeting, process to grant or reject meetings, and alternative mechanisms to obtain feedback. Meeting with regulators are critically needed to create an acceptable development strategy, and get timely feedback from reviewers. Meeting with regulators have been demonstrated to radically reduce the overall time to market for the regulated product.
Areas Covered in the Session:
  • Types of meetings and EMA and several Notified Bodies
  • Key guidelines available from regulators
  • Preparing the meeting request and meeting briefing book
  • Preparing for the meeting
  • Regulator’s review process and sponsor consultation
  • Logistics of the Regulatory meetings
  • Follow-up to the meeting with a regulatory agency
  • Do’s and don’ts of meetings with European regulators
Why should you attend:
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​This seminar will discuss the various kinds of regulatory meetings with EMA and NBs in several countries to highlight the factors governing grant or rejection of meeting, format, tone and conduct of such meetings. Depending on the kind of product being developed, sponsors can have various kinds of meetings with the regulators to gain insight about their expectations and nuances of the regulatory process whether Europe-wide or in specific countries of interest. Practical considerations for non-European companies will be discussed. The seminar will discuss the dos and don’ts of meetings with European regulators describing common mistakes and possible solutions using real-life case studies. Techniques in preparing for meetings with EMA and NBs, from the initial request to close-out of discussions post-meeting will be discussed.
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 drug and biologics products
Date: December 12, 2016
​Duration: 60 Minutes
​Time: 12PM EST

Speaker
Mukesh Kumar, PhD, RAC
Brij Strategic Consultations,
​USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com