RAPS New York-New Jersey Chapter: Developing Regulatory Affairs Expertise—Key Practices to Increase Knowledge Base

In today’s competitive market, regulatory professionals need regulatory and business insight to provide more value on project teams and achieve smoother agency reviews. But developing quality experience and expertise in regulatory is not solely based on the time spent compiling regulatory applications. There are a number of practices and resources that can help professionals enhance their knowledge base and make them more effective in their role.

This presentation is intended to familiarize regulatory associates, specialists and managers with practical strategies to help them or their department gain expertise. Specifically, the presentation will cover how to better anticipate FDA concerns, provide informed assessments and improve business decision-making. It will cover a range of recommended practices that can be implemented to broaden and deepen a professional’s pool of regulatory experience.

This event is sponsored by the RAPS New York/New Jersey Chapter and is intended to facilitate networking and knowledge sharing among area regulatory personnel. A light meal will be available for all attendees. RAC holders may claim two RAC recertification credits.




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

At a Glance

Date:

Thursday, 20 April 2017 (5:00–8:00 pm EDT) 

Location:

Porzio, Bromberg & Newman
100 Southgate Parkway
Morristown, NJ 07962

Directions are available online.

RAC Credits:

Two RAC certification credits upon completion of the program. 

Registration Fees:

Prior to 14 April 2017
RAPS Members: $25
List: $40

On or after 14 April 2017
RAPS Members: $35
List: $50

Seating is limited. Advance registration is required; no onsite registration is available. Register early to secure a seat.

Objectives & Audience

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

  • Identify different resources to gain key business and product-related information
  • Make use of FDA’s warning letters website, submission databases and past product reviews
  • Understand how these tools can improve regulatory decision-making

Agenda

Thursday, 20 April 2017

5:00–6:00 pm         Registration, Networking and Dinner
6:00–7:00 pm         Speaker Presentation
7:00–8:00 pm         Interactive Question and Answer Session

Speaker

Kell Cannon, 3D Communications 

Registration Info

Prior to 14 April 2017
RAPS Members: $25
List: $40

On or after 14 April 2017
RAPS Members: $35
List: $50

>> Registration Online

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

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

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

Program Contact

Local Contact: Linda Bowen, RAC, FRAPS, chair, RAPS New York/New Jersey Chapter

RAPS Contact: Wesley Carr, senior program manager, chapter and volunteer relations

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.