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  5. Regulatory Education for Industry (REdI) Annual Conference May 29-30, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

Regulatory Education for Industry (REdI) Annual Conference May 29-30, 2019

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View CDRH Recordings and Slides     View Agenda

 

Webinar Recordings Speaker
Office of Regulatory Affairs (ORA) Update Joseph Matrisciano Jr. Program Division Director and District Director Division 1
Office of Medical Devices and Radiological Health Operations and New England District Office | ORA | FDA
Plenary: Navigating the World of Combination Products James Bertram CDRH Product Jurisdiction Officer Office of Device Evaluation Center for Devices and Radiological Health
Kristina Lauritsen Combination Product Policy Advisor Office of Executive Programs (OEP) | CDER
Keynote: Center for Drug Evaluation and Research (CDER) Initiatives Doug Throckmorton
Deputy Director for Regulatory Affairs CDER
Meetings: Pre-submission and Special Programs Callie Cappel-Lynch
Senior Regulatory Project Manager
Division of Metabolism and Endocrinology Products (DMEP)
Office of Drug Evaluation (ODE) II
Office of New Drugs (OND) | CDER
NDA and BLA Application Process: A Brief Overview
 		 Swati Patwardhan
Senior Regulatory Project Manager
Division of Anesthesia, Analgesia, and Addiction Products (DAAAP)
ODE II | OND | CDER
Basic Components of New Drug Application/ Biologics License Application (NDA/BLA) Submission Lois Almoza
Regulatory Health Project Manager
Division of Transplant and Ophthalmology Products (DTOP)
Office of Antimicrobial Products (OAP)
OND | CDER
Electronic Common Technical Document (eCTD) and Submission of Study Data Jonathan Resnick
Electronic Submissions Capability Team
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP) | CDER
 
Chao (Ethan) Chen
Director
DDMSS | OBI | OSP | CDER
A Medical Officer’s Approach to NDA/BLA Review Virginia M.W. Sheikh
Medical Officer
Division of Antiviral Products (DAVP)
OAP | OND | CDER
Regulatory Highlights for Biosimilars and Interchangeables Eva Temkin
Acting Director, Policy Staff
Office of Therapeutic Biologics and Biosimilars (OTBB)
OND | CDER
CDER’s Process for Reviewing Nonproprietary Name Suffix for Biological Products and
Safety Considerations for Product Design, Container Labels, and Carton Labeling		 Lubna Merchant
Acting Director
Division of Medication Error Prevention and Analysis (DMEPA)
Deputy Director, Office of Medication Error Prevention and Risk Management (OMEPRM)
Office of Surveillance and Epidemiology (OSE) | CDER
CDER’s Review of the Prescribing Information Ann Marie Trentacosti
Medical Lead
Labeling Development Team
OND | CDER
Ready to Launch: Essentials of Submitting Initial Materials to the Office of Prescription Drug Promotion Rachael Conklin Regulatory Review Officer
Office of Prescription Drug Promotion (OPDP)
Office of Medical Policy (OMP) CDER
SBIA – Program Overview Renu Lal
Lieutenant, USPHS
Pharmacist
SBIA | DDI | OCOMM | CDER
Chemistry Manufacturing and Controls (CMC)– NDA requirements and Common Pitfalls of Biologics License Applications (BLAs) Balajee Shanmugam
Branch Chief
Division of New Drug Products
ONDP | OPQ | CDER
Steven Bowen
Chemist
Office of Biotechnology Products
OPQ | CDER
The Dos and Don’ts of Pre-Approval Inspections: What to Expect When Being Inspected Sean Marcsisin
Lieutenant, USPHS
Office of Pharmaceutical Quality Operations
Pharma Division 1
Investigations Branch 1
ORA | FDA

About This Event

CDER and CDRH invite you to interact with and learn directly from FDA’s regulatory experts. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Attendees will leave with a set of tools to assist in preparing regulatory filings and interacting with the FDA. FDA speakers will be available to answer questions one-on-one at the end of each day.

Drugs track: Will focus on the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs).

Devices track: Will address globalization, harmonization, and standardization of medical device regulation.

Topics

  • Plenary Session: Navigating the World of Combination Products
  • A Medical Officer’s Approach to NDA/BLA Review
  • Regulatory Highlights for Biosimilars and Interchangeables
  • Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements
  • Building Quality Clinical Data into Premarket Approval Applications (PMAs)

Keynote Speakers

  • Doug Throckmorton, MD | Deputy Director for Regulatory Affairs | CDER | FDA
  • William H. Maisel, MD, MPH | Director, Office of Device Evaluation | CDRH | FDA
  • Joseph Matrisciano Jr. | Director, New England District Office | Office of Regulatory Affairs | FDA

Who should attend?

Those interested in the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submissions and globalization, harmonization, and standardization of medical device regulation.

  • Newcomers, managers, or directors in the drug or medical device industries
  • Regulatory affairs
  • Research and development
  • Quality assurance and control
  • Development and preparation of submissions

FDA Sponsoring Offices

This event is a collaboration between the

Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA)
–––– and ––––
The Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE)

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