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NH Berlin Alexanderplatz

Apr 24, 2017 8:00 AM - Apr 24, 2017 4:30 PM

Landsberger Allee 26-32, 10249 Berlin, Germany

EU Health Authorities Scientific and Regulatory Advice

NEW OFFERING! The course is built up as a dialogue between industry and regulator perspective and will teach you what authorities pay attention to, what inquiries they make and what they expect to hear from sponsors.

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Overview

Meetings with Health Authorities (HA) constitute milestones during both the initial drug development process as well as during lifecycle management. This course will equip you and your team with the skills required to adequately decide on, prepare for and execute a successful meeting. The course is built up as a dialogue between the industry and regulator perspective with Do’s and Don’ts and will teach you what authorities pay attention to, what kind of inquiries they make and what they expect to hear from sponsors.
The course is built around participant interaction and advanced level teaching for experienced professionals as well as those attending their first meetings. The focus is on authority meetings in the EU but will also touch upon FDA meeting specificities.

Who should attend?

Professionals in regulatory affairs, project management and product development. The course will serve as a good preparation for an upcoming authority meeting.

Learning objectives

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

  • Work with their project teams to make the right decisions regarding HA meetings
  • Present their case, make their point and use their time managing HA meetings efficiently
  • Understand how HAs think and act – by putting themselves in the shoes of the authority
  • Know how to listen to regulators, anticipate their questions
  • Implement the advice received

Plan Your Team's Professional Development

The world of health care product development is rapidly evolving. To keep you at the forefront, DIA offers a broad selection of expert-led training courses in the key disciplines of Regulatory Affairs, Clinical Research and Pharmacovigilance, as well as courses created to develop other key competencies in the area of e.g. Biosimilars or HTA.

DIA can deliver this course at your organisation on dates that suit you. Our offerings can be customised to meet your exact needs. Learn how DIA can bring our outstanding training programmes directly to you and your team.
For more information please contact EMEA@diaglobal.org.

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