Communication With FDA: What Do We Say And How Do We Say It?

Teachers
Michael Drues
Category:
Regulatory & Compliance/ On Demand Courses/ Introductory Courses/
Clear
Duration: 90 minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Effective communication with FDA is critical in successfully bringing any therapeutic product to market.  However, communication includes much more than the written regulatory submission.  Effective communication with FDA in all its forms must be concise, carefully considered, and reviewed to achieve the desired outcome.

One must ask several questions before engaging in correspondence with FDA.  When are we required to communicate with FDA?  More importantly, when should we communicate with FDA?  What should we say and how should we say it?  What should we not say and how should we not say it?  It’s not what you say that matters – it’s what people hear!

LEARNING OBJECTIVES

Using the case study approach, all of these questions and others will be answered in an interactive fashion, including:

  1. When are we required to communicate with FDA? When should we? Is it ever too early?
  2. What should we say and how should we say it? What should we not say and how should we not say it?
  3. Who should communicate with FDA and who should not?  When should it be verbal, and when in writing?
  4. When should we communicate formally vs. informally?
  5. How do we avoid timely and costly mistakes and how can we use creative ways to use communication with FDA to our advantage!

Who Should Attend

WHO SHOULD ATTEND

Geared for both experienced life science professionals as well as those new to the industry, this webinar is designed for those who need a better understanding of how to communicate effectively with FDA to bring pharmaceutical, biotech, and medical device products to market. This unique seminar demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities. Strategies for using regulation as a competitive advantage will also be discussed. Scientists, product and product development managers, business development managers, marketing managers, QA/QC personnel, regulatory affairs professionals, investment and acquisition specialists and field service engineers will all benefit from this webinar.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Michael Drues
Works regularly for the FDA, Health Canada, the US and European Patent Offices, and other regulatory and governmental agencies worldwide.

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