Horizons 2006—RAPS Conference and Exhibition: Innovation to Regulation

Venue: Westin Horton Plaza Hotel

Location: San Diego, California, United States

Event Date/Time: Mar 29, 2006 End Date/Time: Mar 31, 2006
Registration Date: Mar 27, 2006
Early Registration Date: Mar 14, 2006
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Horizons 2006—RAPS Conference and Exhibition: Innovation to Regulation
29-31 March 2006

Westin Horton Plaza Hotel
910 Broadway Circle
San Diego, CA 92101

For Exhibitors
Reserve your tabletop
to exhibit today!

Horizons 2006—RAPS Conference & Exhibition: Innovation to Regulation (formerly West Coast Conference) is a multi-track educational and networking experience. This conference encompasses international perspectives across product lines and features multiple educational tracks, exhibits and opportunities for professionals in regulatory affairs, clinical trials and R&D to meet with peers.

The conference features five tracks:

early development
exposure to RA
senior RA
submission to market
Within each track, drug, device and biologics topics are highlighted, with a significant focus on international issues. Exclusive sessions also cater to the senior professional, and introductory workshops focus on those desiring exposure to regulatory affairs.

Just in!

Keynote Address: RAPS has secured D. Keith Grossman, President and CEO, Thoratec Corporation, and Bob O’Holla, Vice President, Regulatory Affairs, Johnson & Johnson Inc., to deliver this year’s keynote address, The Strategic Role of the Regulatory Professional.

FDA Briefings will include a CDRH briefing by Daniel G. Schultz, MD, Director, Center for Devices & Radiological Health, US Food & Drug Administration and a CDER briefing by Nancy D. Smith, PhD, Director, Office of Training & Communication, Center for Drug Evaluation & Research, US Food & Drug Administration.
Reasons to Attend

Participants from regulatory agencies, industry, academic and research institutions around the world are expected to attend this conference. It was developed to promote the advancement of continuing professional education to the RA professional who maintains experience in technical, compliance and management areas.

Whether new to regulatory affairs or well-versed in the intricacies of the profession, this conference was designed to further participants’ professional development. Senior professionals will also benefit from the interaction with FDA officials and the regulatory updates.

Learning Objectives

Participants will learn the latest in regulatory strategy and developments from regulatory experts around the world. Sessions will address the topical and relevant issues relating to drugs, biologics, medical devices and international affairs, with a particular focus on early lifecycle development.

Registration Rates Until March 14 After March 14
Member Registration $925 $1025
Nonmember Registration $1110 $1210


910 Broadway Circle
San Diego
United States

Additional Information

Horizons 2006—RAPS Conference and Exhibition: Innovation to Regulation Agenda Click on session title for session description and speaker(s). Speakers and descriptions will be added when available. Wednesday, 29 March 2006 1:30 pm - 3:00 pm Translation Best Practices: Managing Risk by Managing Product Content Creation Business Requirements for Medical Device Product Development CMC Development Focus on Europe Ethics: What the New RA Professional Needs to Know 3:00 pm - 3:30 pm Break 3:30 pm - 5:00 pm Navigating Japan's Device Approval Process: Lessons Learned Opportunities for Expediting Drug Development & Approval The Importance of Genomic Biomarkers, Especially in the Context of FDA's Critical Path Initiative Thursday, 30 March 2006 8:30 am - 10:00 am KEYNOTE: The Strategic Role of the Regulatory Affairs Professional 10:00 am - 10:30 am Break 10:30 am - 12:00 pm Clinical Regulatory Issues with Combination Products Early Development Issues in IVDs Structured Product Labeling Transitional Management: How to Succeed in Really Tough Situations 12:00 pm - 1:30 pm Lunch 1:30 pm - 3:00 pm Europe: Future Medicines Legislation Becomes New Medicines Legislation GLP Studies: When are They Appropriate and How to Audit for Compliance Investigational Device Exemptions (IDEs): Overview of IDE Regulation, Gaining FDA Approval & Getting Started Supply & Demand of the Regulatory Professional: Bridging the Gap 3:00 pm - 3:30 pm Break 3:30 pm - 5:00 pm Clinical Trials: Overview of Managing Clinical Trials, Quality & Compliance Regulatory Insights on Tissue Engineering: From Lab to Market The eCTD, The Regulatory Affairs Professional & the Agency Friday, 31 March 2006 10:30 am - 12:00 pm CDRH Briefing Chinese Regulatory Environment for Medical Devices & Drugs Market Exclusivity and Orphan Drug Designation 12:00 pm - 1:30 pm Lunch 1:30 pm - 3:00 pm Clinical Trials in Latin America and India CDER Briefing Negotiating with Agencies Successfully Risk Management for Medical Devies 3:00 pm - 3:30 pm Break 3:30 pm - 5:00 pm Reimbursement Strategies for Early Stage Device Companies The Role of PMDA in the Promotion of Global Development Third Party Reviews, Third Party Audits & Transferring 510(k)s: The Current View