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2019 Annual Meeting and January Program: How to transition into regulatory affairs and successful regulatory professional insights

January 15 @ 8:00 AM - 5:00 PM PST

REGISTER HERE

2019 Annual Meeting

&

2020 January Program

Join us for a brief 2019 SDRAN recap
immediately followed by the open forum discussion entitled:

How to transition into regulatory affairs
and successful regulatory professional insights

Moderator: Christine Federovitch, Ph.D., RAC

Wednesday, January 15, 2019

FLYER

Event Agenda:

Date: Wednesday, 15 January 2020

Time*:

5:00 – 5:30 PM Registration, Networking and Snacks

5:35 – 5:40 PM  Welcome – Christine Federovitch & Erica Livingston

5:45 – 6:00 PM Annual Meeting

6:00 – 6:20 PM Regulatory Career Opening Presentation, Allison Aguirre

6:20 – 7:30 PM Open Forum Discussion, Moderator, Christine Federovitch

*Times are approximate.

Open Forum or “Aquarium” dicussion:

Join us for an exciting new meeting format where RA leaders kick off a series of deep discussions on how people can transition into regulatory affairs and share some tips on how to be a successful regulatory professional. Attendees in the audience gaze into the fishbowl – in the SDRAN aquarium – listening and learning while these lively and insightful discussions ensue. Audience members may “tap in” and join the discussion. When a new person enters the discussion, someone else leaves and the conversation picks up again – with a new perspective added or a shift of the lens. The facilitated discussion will address the following questions:

1. What skills (translatable skills and soft skills) do you need to be successful in Regulatory?

2. How to get into the career of Regulatory Affairs?

3. What are the hiring trends and future outlook of the profession?

4. How to maintain the work life balance as a regulatory professional?

5. How to keep up with the latest development in the regulatory field?

6. How to advance your career as a regulatory professional?

Speaker Biographies:

Allison Aguirre is a San Diego local who attended Torrey Pines High School. Graduated this summer from University of California, Santa Barbara with a major in Communications and minor in Professional Writing. Alison began working at Real Life Sciences in August, where she recruits for regulatory affairs. Her areas of expertise include regulatory strategy, CMC, and regulatory writing.inda has 36 years-experience in the BioPharma Industry, of which 26 years have been spent in regulatory affairs. She is Head of Regulatory Policy and Intelligence at Seattle Genetics and Assistant Professor in the Temple University RAQA graduate program for the last 20 years.

Christine Federovitch, PhD, RAC is an active Board Member of SDRAN, having served on the Board in multiple roles. Her most recent role in 2019 was to serve as President. Christine Federovitch, PhD, RAC, has over 10 years of Pharmaceutical and Medical Device experience with varied roles in Program and Clinical Trial Management, Alliance Management, Business Development and Operations. In her recent role with Navigate BioPharma Services Inc., a Novartis subsidiary, Christine leads the Operational Excellence program in addition to leading the Manufacturing and Laboratory Operations departments. She has contributed to several companion diagnostic partnerships focused on oncology biomarkers, in various pre-submission meetings with the FDA, preparation of manufacturing modules for PMA submission and CE marking, as well as PAIs. Christine received her Doctorate in Biology from University of California, San Diego and her Baccalaureate in Biochemistry from the University of Nevada, Reno. She also earned her US RAC credentials from RAPS in 2010.

Location:

UCSD Extension

University City Center

6256 Greenwich Drive

San Diego, CA 92122

**  Please make your reservation early. The pre-registration due date is Monday, 13th January 2020. Advanced registration is appreciated to assist in event planning.

** Space is limited for our monthly programs. Registration is capped at 84 participants. Register today to ensure your seat. Once our limit is reached, registration will close. Events with closed registration will not allow walk-ins.

Online registration (through Monday 18 November 2019):
$20 SDRAN Member

$30 Non-Member

Onsite Registration:
$30 SDRAN Member

$40 Non-Member

For Questions Email: programs@sdran.org

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