RAPS Chicago Chapter: Effective Medical Device Presubmission Interactions

23 January 2017
5:30–8:30 pm CST
AbbVie Inc.
North Chicago, IL


Join your regulatory colleagues from the Chicagoland area for an evening of networking and an interactive presentation on the Medical Device Presubmission process. The program is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with other in the local regulatory community.

When your device is cutting edge, it’s usually best to meet with FDA informally before you send in your request for approval, clearance or clinical study. FDA’s presubmission program is in place to address this need. This presentation will review the program and participants will come away better informed about the details of the program and insight into general principles applicable to all sorts of early interactions with regulatory agencies.

Upon the programs conclusion, attendees will:

  • Understand the presubmission program’s purpose and mechanics
  • Understand basic presubmission application contents
  • Understand how to get the most out of a presubmission interaction
  • Learn principles and effective strategies for any informal FDA meeting

A light meal will be provided and participants may claim two RAC recertification credits.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Speakers
  • Registration Info
  • Cancellation

At a Glance

Date:

Monday, 23 January 2017 (5:30–8:30 pm CST)

Location:

AbbVie Inc.
One North Waukegan Road
AP 30 LL Conference Room E
North Chicago, IL 60064-6220

Find directions online or call +1 800 255 5162. For your convenience, a map of the Abbvie campus is available for download.

RAC Credits:

2 RAC recertification credits upon completion of the webcast/program.

Registration Fees:

Prior to 16 January 2017
RAPS Members: $30
List: $45

On or after 16 January 2017
RAPS Members: $40
List: $55

 

Objectives

At the conclusion of this program, you will be able to:

  • Understand the presubmission program’s purpose and mechanics
  • Understand basic presubmission application contents
  • Understand how to get the most out of a presubmission interaction
  • Learn principles and effective strategies for any informal FDA meeting 

Agenda

Monday, 23 January 2017 (5:30–8:30 pm CST)

5:30–6:00 pm             Registration, Check In

6:00–7:00 pm             Networking and Dinner

7:00–8:30 pm             Speaker Presentation and Q/A Session

Speakers

Daniel J. Dillon, RAC, senior regulatory scientist, MED Institute

Registration Info

Prior to 16 January 2017
RAPS members: $30
List: $45

On or after 16 January 2017
RAPS members: $40
List: $55

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Individuals wishing to register after the registration deadline,may register only by phone.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

If you are not a member or an existing RAPS customer, you will need to create an account to purchase this item.

Program Contact

Carol Cooper, RAC, chair, RAPS Chicago Chapter 

 

 

 

Cancellation

RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing or by calling customer service. Supporting documentation is required and must be received by the deadline specified. Chapter events with registration fees less than $100 will not be refunded. For events that exceed this amount a 20% cancellation fees will be assessed.

 

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email, to raps@raps.org

 

Substitutions may be accepted with written approval from RAPS.