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4th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference



 
Our Price: $395.00

Product Code: 2153
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ABOUT THE CONFERENCE

Diagnostic testing has reached monumental heights providing physicians and patients with lifesaving information and healthcare opportunities. As innovation continues to evolve and tests advance in their complexity, the challenges in assuring regulatory approval increases in tandem. Manufacturers face numerous hurdles in defining clinical evidence to support and secure timely regulatory approval in an increasingly competitive marketplace. This annual conference program brought together regulators as well as industry experts who shared and discussed the challenges faced in bringing new tests to the market, as well as the strategies used to navigate through an uncertain and evolving regulatory environment.

KEY CONFERENCE TAKEAWAYS
  • How to survive the FDA’s Enhanced Scrutiny of Human Factors
  • Tips and Tools when Utilizing the eCopy Program for Regulatory Submissions
  • How best to Prepare for EU Regulatory Changes for In Vitro Diagnostics
  • Best Practices in Maintaining a Global Mindset during Diagnostic Clinical Trails
  • Understand the Clinical and Regulatory Hurdles for Next Generation Sequencing
  • Key Stakeholder insight on FDA Intentions to Regulate Lab Developed Test
PRODUCT INFORMATION:
Presentations slides are in PDF. format
All files are available for immediate download.

INCLUDES THESE PRESENTATIONS:

ASSURANCE OF PRECISE & COMPLIANT DATA COLLECTION DURING DIAGNOSTIC CLINICAL TRIALS
Luc Van Hove, MD, PhD, CSSBB, Sr Director Medical/Clinical, Regulatory & Quality
ASURAGEN, INC

PRE-SUBMISSION MEETINGS: WEIGHING THE TIME & INVESTMENT
Sandra D. White, M.S., RAC, Director, Regulatory Services
Aptiv Solutions

BIOMERIEUX CASE STUDY: EXAMINATION OF FDA GUIDANCE ON DIAGNOSTIC INSTRUMENTS WITH COMBINED FUNCTIONS
Sandy Perreand, Executive Director of Global Regulatory Affairs,
BIOMERIEUX

ATTAINING TEST VERIFICATION AND VALIDATION FOR MOLECULAR DIAGNOSTIC ASSAYS
Bill Kurani, MSEE, MSRA, Director, Regulatory Affairs & Quality Assurance
NATERA, INC.

GRASPING EXPECTATIONS: DISCUSSION ON RECENT COMPANION DIAGNOSTIC APPROVALS
Lakshman Ramamurthy, PhD, Director, FDA Regulatory Strategy & Policy
AVALERE HEALTH, Entrepreneur-in-Residence, FDA

Jennifer Shen, PhD, RAC, Scientific Reviewer, Office of In Vitro Diagnostics and Radiological Health (OIR)
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) / FDA

Tadd S. Lazarus, M.D., Chief Medical Officer & Head, Medical Affairs, Global Molecular Diagnostics
QIAGEN, Inc

KEY STAKEHOLDER DISCUSSION: FDA INTENTIONS TO REGULATE LAB DEVELOPED TESTS
Moderator :
Valynda Machen, CQA, RAC, Medical Research Manager
NAMSA

Panelists:
Mary Steele Williams, MNA, MT(ASCP)SM, Executive Director
ASSOCIATION FOR MOLECULAR PATHOLOGY

Scott McGoohan, Vice President, Reimbursement and Scientific Affairs
ACLA

Gail Habegger Vance, MD, FCAP
COLLEGE OF AMERICAN PATHOLOGISTS

Andrew Fish, Executive Director
ADVAMEDDX

DECODING THE REVISED 510(K) SUBMISSION PROCESS FOR A CHANGE TO AN EXISTING TEST
Tony Lam, Vice President Regulatory Affairs and Quality Assurance
ADVANCED CELL DIAGNOSTICS

SURVIVING THE FDA’S ENHANCED SCRUTINY OF HUMAN FACTORS
Stephen Wilcox, Ph.D., FIDSA, Founder
DESIGN SCIENCE

WORKSHOP: PREPARING FOR FUTURE REGULATORY CHANGES IN THE AREA OF DIAGNOSTIC FLOW CYTOMETRY
Bruce Davis, MD, President
TRILLIUM DIAGNOSTICS, LLC

Curtis A. Hanson, MD, Consultant, Division of Hematopathology Department of Laboratory Medicine and Pathology; Professor of Laboratory Medicine and Pathology
MAYO CLINIC COLLEGE OF MEDICINE

Gerald Marti, MD, Medical Officer, Office of In Vitro Diagnostics and Radiological Health
(OIR), CDRH FDA

NANOSPHERE CLINICAL & REGULATORY CO-PRESENTATION: SUCCESS IN MOLECULAR MICROBIOLOGY DIAGNOSTICS
Terry Raich, Director of Clinical Affairs
NANOSPHERE

Mark Del Vecchio, Vice President of Regulatory Affairs
NANOSPHERE

UNIQUE DEVICE IDENTIFIERS: WHAT’S “UNIQUE” ABOUT DIAGNOSTICS?
Valynda Machen, CQA, RAC, Medical Research Manager
NAMSA

ALERE CASE STUDY: CLIA & 510K SEPARATE VS. PARALLEL REVIEW PATHS FOR DIAGNOSTIC ASSAYS: PROS AND CONS
Robert DiTullio, Vice President of Global Regulatory & Clinical Affairs
ALERE

PANEL DISCUSSION: MAINTAINING A GLOBAL MINDSET DURING DIAGNOSTIC CLINICAL TRAILS
Moderator :
Susan Rockwell, Executive Director, Medical Device Strategy
APTIV SOLUTIONS

Panelists:
Deborah Kurtock, MT (ASCP), CCRA, Global Head of Study Monitors, Clinical Operations
ROCHE DIAGNOSTICS

Jonathan McDermed, PharmD, Director Scientific & Clinical Affairs, Iris Personalized Medicine Division
BECKMAN COULTER, Inc.

Roy Marcus, Global Senior Director of Clinical Affairs
BIOMERIEUX

Paul Swift, RAC, Regulatory Affairs Project Manager
BD Diagnostics

PANEL DISCUSSION: BEST PRACTICES UTILIZING THE ECOPY PROGRAM FOR REGULATORY SUBMISSIONS
Peggy Carter, Ph.D., RAC, Director, Regulatory Affairs
NOVARTIS COMPANION DIAGNOSTICS

Paul Swift, RAC, Regulatory Affairs Project Manager
BD Diagnostics

Kennon P. Daniels,Ph.D., Director of Regulatory Affairs
Beaufort , LLC

PREPARING FOR EU REGULATORY CHANGES FOR IN VITRO DIAGNOSTICS
Sue Spencer, Head of IVD
BSI



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