Regulatory Education for Industry (REdI) Annual Conference May 29-30, 2019
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)
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The Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE)