Clinical Trials 101
Joint Meeting with San Diego Regulatory Affairs Network
(SDRAN)
and
Orange County Regulatory Affairs Discussion Group
Wednesday, October 30, 2013
Location: Grand Pacific Palisades Resort & Hotel
5805 Armada Drive, Carlsbad, CA 92008
Speakers:
Ginger Clasby, VP, Clinical & Regulatory Affairs, Transcend Medical
Grace Furman, PhD, President & CEO, Paracelsus, Inc.
Laurie Halloran, President, Halloran Consulting Group
Barney King, MD, President, Macnas Consulting International, Inc.
Elizabeth Ludington, Vice President, Biometrics, Agility Clinical, Inc.
Linda Strause, PhD, Strategic Research Consultant
Synopsis:
The Clinical Affairs cohort for all Device, Pharmaceutical, and Biologics companies is responsible for demonstrating the safety and efficacy of their innovative end product in humans. It is this efficacy that is an essential component utilized to obtain regulatory approval from global regulatory bodies (e.g. FDA, TGA, CMDR, etc.) to market our products worldwide. “As a regulatory professional, you have a significant role in clinical trial management, so it is imperative that you understand the clinical research process and basic issues associated with the infrastructure elements required for the successful management of clinical trials.” (RAPS 2013)
Clinical Affairs 101 will expose you to all phases of a Clinical Trial, from Protocol Development through Regulatory Submission. Additionally, there will be separate breakout sessions for Pharmaceuticals/Biologics and Devices/IVD. At these breakout sessions you will have the opportunity to pose hypothetical questions to the panel and receive helpful suggestions from some of the most experienced professionals in the business. So come join your fellow clinical professionals in beautiful Carlsbad, California at the Grand Pacific Palisades to share your expertise with some and gain expertise from others.
Schedule:
7:30 – 8:30 am
Registration and Continental Breakfast
8:30 – 9:00 am
Keynote Speaker: Laurie Halloran
9:00 – 9:50 am
Overview of Clinical Trials and Effective Trial Design: Barney King, MD
9:50 – 10:00 am
BREAK
10:00 – 10:50 am
Basics of Trial Design/Statistics (IDE, IND, Combos)
11:00 – 11:50 am
IRB and Ethics: Linda Strause, PhD
12:00 – 1:00 pm
LUNCH
1:00 – 1:50 pm
Site Preparation and Monitoring: Ginger Clasby
2:00 – 2:50 pm
Data Management: Grace Furman
3:00 – 3:10 pm
BREAK
3:10 – 4:00 pm
Break Out Sessions:
1. Drug/Biologics
Pharma Best Practices (Panel) – Discussion/Q&A
Barney King, Grace Furman, Eliz Ludington
2. Devices/IVDs
IVS Trial Overview – N Kennel
Device Best Practices (Panel)-Discussion/Q&A
Natalie Kennel, Ginger Clasby, Linda Strause, PhD
4:00 – 4:30 pm
Closing Remarks: Barney King
Cost:
OCRA and SDRAN Members: $199
Government and Students: $100
Registration fee includes breakfast, lunch, beverages and snacks. After the meeting, electronic access to the presentations will be made for all attendees. Dress code: Business casual
