NCC ACRP: Regulatory Year in Review: What Happened in 2018 (and how does it impac

When:  Mar 28, 2019 from 6:00 PM to 9:00 PM (PT)
Please join us for the NCC ACRP Regulatory Year in Review: What Happened in 2018 (and how does it impact you) event. Session starts promptly at 7:00 PM.

Meredith Brown-Tuttle, RAC, FRAPS will review for use the regulatory changes that have taken effect since 2018. What is new? What has stayed the same? How does it impact you?

Learning Objectives:
o Describe the changes in the 2018 regulatory landscape 
o Evaluate the impact of regulatory changes to day to day clinical function
o Understand the coming trends and regulatory changes in 2019

Agenda:

6:00 – 6:45 PM Registration, Networking, & Dinner Buffet

6:45 – 7:00 PM President’s Welcome

7:00 – 8:00 PM Educational Presentation with Q&A

8:00 – 8.45 PM Raffle, Open Mic, Networking

Target Audience: 
Open to the clinical research community including sponsors, study sites, vendors, IRBs, support/related functions, and students.

Speaker's Bio:
Meredith Brown-Tuttle, RAC, FRAPS, has 26 years of industry experience from bench to clinic to approval of both drugs and devices. Meredith has written and coordinated numerous drug and biologic submissions to US and international regulatory agencies, developed global regulatory strategies and conducted worldwide regulatory intelligence. She owns and contributes to the much sought-after strategy/intelligence consultancy, Regulatoium. Meredith has written, managed and led over 30 successful domestic and international IND and NDA submissions. She is a founding instructor at UC Santa Cruz Regulatory Certificate Program and author of two books: “IND Submissions: A Primer” and “Regulatory Intelligence 101.” Meredith graduated with a BA in biological psychology (neuroscience) from San Jose State University.

Online event registration: 
Registration closes on Wednesday, March 27th at midnight Pacific Time.

Walk-in registration: 
If seats available - add $5 to the registration fee ($10 total for chapter members and students, $35 total for non-chapter members)

Bring your email confirmation to the event. Please notify the Event Manager for cancellations. No refunds or transfers. 

Contact Hour:
The Association of Clinical Research Professionals (ACRP) provides 1.0 continuing education credits for the completion of this educational activity. These credits can be used to meet the certification maintenance requirement. (ACRP-­2019-­CPT­-140). Please click here to purchase the contact hour.

For event registration questions, please contact Event Manager Tom Pamukcu at tom.pamukcu@nccacrp.org

Funding and in-kind support provided by the following sponsors do not influence the content of this program.

Location

Cepeid
1315 Chesapeake Terrace,
The Mediterranean conference room
Sunnyvale, CA 94089

Contact

Danusia Filipowski
(925)212-3168
Danusia_f@hotmail.com