Skip navigation
Speakers

Recent Enforcement Updates • Risk-based Decision Making • Navigation of Global Requirements

September 16-18, 2019
  • Silver Spring, MD

Doris M. Apel, JD, RAC
Manager, Regulatory Affairs
Varian Medical Systems, Inc.

Patrick Caines, PhD
Senior Director, Quality & Compliance
Baxter Healthcare

Edgardo Colon
Product Complaint Process Owner
Amgen

George Cusatis
Associate Director, Device & Digital Health
Merck

Brian Daleiden
VP Industry Marketing/Community and Co-Founder
TraceLink

Ileana Elder, PhD
Branch Chief, Recalls and Shortages Branch
CDER|FDA

Kevin Escapule
Director, Post Market Surveillance
Zimmer Biomet

NiCole Head
Manager, National Product Safety & Recall
Kaiser Permanente

Eric Henry
Senior Quality Systems & Compliance Consultant,
FDA and Life Sciences Practice
King & Spalding

Stine Jacobsen
Senior Complaint and Recall Advisor
Novo Nordisk A/S

Beverly Lorell, MD, FACC
Senior Medical and Policy Advisor, FDA Life Sciences Group
King & Spalding LLP

Erik P. Mettler
Assistant Commissioner, MPA, MPH, ORA
FDA

Thomas Morrissey, MD
Vice President, Product Safety
Edwards Lifesciences

Steven Niedelman
Lead Quality System and Compliance Consultant
King and Spalding

Christina Wøhlk Nielsen
Complaint and Recall Advisor
Novo Nordisk A/S

Darin Oppenheimer
Executive Director, Drug-Device Center of Excellence
Merck

Larry Perruzza, MSc, RAC
Director, Product Quality Vigilance - Combination Products NA/LATAM
Janssen Pharmaceuticals

Geetha Rao
CEO
Springborne Life Sciences

Dyana Stone
Consumer Safety Officer, ORA
FDA

Lea Ngar Tan
Global System Owner for Product Complaints, Alert and Recalls
EMD Serono

Sandy Weininger
Senior Electrical/Biomedical Engineer
FDA

Beth Wells
Senior Director, Community Engagement
GS1 US

Cecilia Wolyniak
Lead Consumer Safety Officer
FDA

Doris M. Apel, JD, RAC
Manager, Regulatory Affairs
Varian Medical Systems, Inc.

Patrick Caines, PhD
Senior Director, Quality & Compliance
Baxter Healthcare

Edgardo Colon
Product Complaint Process Owner
Amgen

George Cusatis
Associate Director, Device & Digital Health
Merck

Brian Daleiden
VP Industry Marketing/Community and Co-Founder
TraceLink

Ileana Elder, PhD
Branch Chief, Recalls and Shortages Branch
CDER|FDA

Kevin Escapule
Director, Post Market Surveillance
Zimmer Biomet

NiCole Head
Manager, National Product Safety & Recall
Kaiser Permanente

Eric Henry
Senior Quality Systems & Compliance Consultant,
FDA and Life Sciences Practice
King & Spalding

Stine Jacobsen
Senior Complaint and Recall Advisor
Novo Nordisk A/S

Beverly Lorell, MD, FACC
Senior Medical and Policy Advisor, FDA Life Sciences Group
King & Spalding LLP

Erik P. Mettler
Assistant Commissioner, MPA, MPH, ORA
FDA

Thomas Morrissey, MD
Vice President, Product Safety
Edwards Lifesciences

Steven Niedelman
Lead Quality System and Compliance Consultant
King and Spalding

Christina Wøhlk Nielsen
Complaint and Recall Advisor
Novo Nordisk A/S

Darin Oppenheimer
Executive Director, Drug-Device Center of Excellence
Merck

Larry Perruzza, MSc, RAC
Director, Product Quality Vigilance - Combination Products NA/LATAM
Janssen Pharmaceuticals

Geetha Rao
CEO
Springborne Life Sciences

Dyana Stone
Consumer Safety Officer, ORA
FDA

Lea Ngar Tan
Global System Owner for Product Complaints, Alert and Recalls
EMD Serono

Sandy Weininger
Senior Electrical/Biomedical Engineer
FDA

Beth Wells
Senior Director, Community Engagement
GS1 US

Cecilia Wolyniak
Lead Consumer Safety Officer
FDA