RAPS Indiana Chapter: Optimizing Communications With the Office of Surveillance and Epidemiology

Come join us to connect with others from your local regulatory community and hear an interactive presentation from a senior FDA representative about processes and procedures of the Office of Surveillance and Epidemiology (OSE) within the Center of Drug Evaluation and Research (CDER). This session is brought to you by the RAPS Indiana Chapter and is intended to promote engagement between government, industry and academia.

This presentation will provide an overview of the OSE, the role of OSE in the continuum of drug safety lifecycle management and will include recent operational updates, and anticipated updates, from PDUFA VI. The audience will also learn how the role of the OSE Safety Regulatory Project Manager and regulatory expert as point of contact for industry can help achieve optimal communication.

Don’t miss this unique opportunity to network with others from your region and to ask specific questions to an agency representative. A light meal will be provided. RAC holders may claim two RAC recertification credits.




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

At a Glance

Date:

Thursday, 9 March 2017 (5:30–8:00 pm EST) 

Location:

Purdue University
Seng Liang Wang Hall 
516 Northwestern Avenue
West Lafayette, IN 47906

Find directions online.

RAC Credits:

Two RAC certification credits upon completion of the program 

Registration Fees:

Prior to 3 March
RAPS Members: $30
List: $45

On or after 3 March
RAPS Members: $40
List: $55

 

Objectives

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

  • Define the role of OSE in premarket and postmarket drug safety activities of drug lifecycle safety management at CDER.
  • Identify recent and future operational updates in OSE of PDUFA V and VI
  • Apply the information covered in this presentation when engaging with the FDA.

Learning Level(s)

  • Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
  • Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.  



Agenda

Thursday, 9 March 2017 (5:30–8:00 pm EST)

5:30–6:30 pm             Registration Check-in, Networking and Dinner

6:30–7:30 pm             Speaker Presentation

7:30–8:00 pm             Interactive Question/Answer Period

 

Speaker

Jill R. Bourdage, RPh, PMP, director, project management and associate director, regulatory affairs, Office of Surveillance and Epidemiology, CDER, US FDA

Registration Info

Prior to 3 March
RAPS Members: $30
List: $45

On or after 3 March 
RAPS Members: $40
List: $55

>> 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: Gretchen Bowker, RAC, FRAPS, chair, RAPS Indiana Chapter 

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

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.