RAPS San Francisco Bay Area Chapter: US Regulatory Affairs Certification (RAC) Exam Peer Review Study Group

Are you planning to take the RAC (US) exam? If so, the RAPS San Francisco Bay Area Chapter invites you to participate in a series of peer-led study sessions to help you prepare for the exam. Please pass this along to a colleague if you are already an RAC holder.

This study group consists of a series of five in-person sessions, and is hosted by the University of California Santa Cruz, Silicon Valley Extension in Santa Clara. Each session will include presentations from certified regulatory professionals from industry who will cover topics on pharmaceuticals, medical device and biologics. Attendance of each session is the responsibility of the participant and registration is non-transferable.

It is highly recommended that registrants possess a minimum of two to three years regulatory experience, as the session will be geared towards attendees that have a basic understanding of the regulatory profession. Participation in this peer-led study group should not be your only method of exam preparation. RAPS offers many exam preparation materials which can help you develop a comprehensive study plan.

The flagship publication, Fundamentals of US Regulatory Affairs*, designed for regulatory professionals working in the US market at all levels, will be the primary resource used during the study group sessions. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages, and study group registrants are encouraged to purchase a copy to bring with you.

While a light meal will be provided for lunch at each session, breakfast will not be available.

*The ninth edition of Fundamentals will be available for $100 off until 21 July 2017.




  • At a Glance
  • Speakers
  • Registration Info
  • Cancellation

At a Glance

Date:

22, 29 July and 5, 19, 26 August 2017  (9:00 am–5:00 pm PDT) 

Location:

University of California Santa Cruz
Silicon Valley Extension in Santa Clara 
3175 Bowers Avenue
Santa Clara, CA 95054 

Directions are available online or by calling +1 408 861 3700.

Registration Fees:

Members: $150
List: $200

Speakers

Angela Bazigos, CEO, Touchstone Technologies, Inc.
Victor Chen, director, clinical affairs, Align Technology
Julia Choi, RAC, human factors engineer, Intuitive Surgical
Susan Carino, RAC, principal consultant, Integrated Project Management Company, Inc.
Lynn Deutsch, Consultant, Independent Medical Device Advertising & Promotion Compliance
Sofina Jain, RAC, senior regulatory affairs associate, Par Pharmaceutical Companies, Inc.
Joanne Pelaschier, RAC, CQA, CQE, senior, regulatory specialist, BD Biosciences
Pooja Shah, MS, RAC, senior regulatory specialist, Roche Molecular Systems
Sastry Srikonda, head,  CMC and SC, Galena Biopharma, Inc.
Heinz Steneberg, director of regulatory affairs, Roche Molecular Systems Inc.
Clarisa Tate, vice president, product development & regulatory affairs, AIRx Medical

Registration Info

Members: $150
List: $200

 

>> 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: Susan Carino, RAC, vice chair, RAPS San Francisco Bay Area Chapter
                    Pooja Shah, RAC, education committee, RAPS San Francisco Bay Area Chapter
RAPS contact: Wesley Carr, senior program manager, chapter and volunteer relations

 

 

 

Cancellation

Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.