Agency Presentations

Any organization filing regulatory submissions on a consistent basis must stay informed of the latest Agency guidance and GlobalSubmit engages in a routine dialogue with regional authorities, and is pleased to give you access to the latest webinars and presentations.

DIA Regulatory Submissions, Information, and Document Management Forum, February 8-10, 2016, North Bethesda, MD

Electronic Submissions Update, Ginny Hussong, Director, Division of Data Management Services & Solutions, Office of Business Informatics, CDER (2/8/2016)

eCTD Validation Update, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER (2/8/2016)

GPhA Fall Technical Conference, November 4, 2015, North Bethesda, MD

New Requirement for Electronic Submission of DMFs, Ginny Hussong, Director Division of Data Management Services & Solutions Office of Business Informatics, CDER

DIA eRegulatory and Intelligence Annual Conference, May 11-13, 2015, Philadelphia, PA

Electronic Submissions Update, Ginny Hussong, Director (Acting), Division of Data Management Services & Solutions, Office of Business Informatics, CDER

FDA Update: Submission of Promotional Materials, CDR Roberta Szydlo, RPh, MBA, RAC, Senior Regulatory Review Officer, Office of Prescription Drug Promotion, CDER

FDA’s Module 1 Update, Jared Lantzy, PMP, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

eCTD IV Update, Mark Gray, Senior Project Manager, CBER

Current CDER Initiatives, April 20, 2015

Douglas C. Throckmorton, M.D., Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research (CDER), FDA

Creating The Path to Success with GDUFDA, February 10, 2015

Kathleen Uhl, MD, Director, Office of Generic Drugs, FDA OGD Keynote Address

GDUFA Regulatory Science Update, February 10, 2015

Robert Lionberger, Ph.D., Director, Office of Research and Standards, OGD, CDER, FDA

Electronic Submissions – The Requirement for Standardized Study Data, February 9, 2015

Mary Ann Slack, Deputy Director, Office of Strategic Programs; Ron Fitzmartin, PhD, MBA, Sr. Advisor, Office of Strategic Programs

CDER New Drug Review: 2014 Update, December 11 2014

John K. Jenkins, M.D., Director Office New Drugs, Center for Drug Evaluation

Global Drug Development and its Impact on CDER’s Drug Review Process Symposium, June 24, 2014

Robert Isner, Associate Director for Policy Development, Office of Pharmaceutical Quality

Draft Guidance for Industry ANDA, June 12, 2014

Content and Format of Abbreviated New Drug Applications, Elizabeth, JD, Office and Generic Drugs

Optimizing your eCTD ANDA, March 27, 2014

GDUFA and You 2014, Jared Lantzy, PMP, Data Management Solutions Team, CDER Office of Business Informatics

Update on GDUFA and FDA’s Office of Generic Drugs, February 20, 2014

GPhA Annual Meeting, Uhl, MD, Acting Director, Office of Generic Drugs CDER/FDA

Approved Drugs 2013: Report Issued January 2014

Novel New Drugs 2013 Summary, US FDA Center for Drug Evaluation and Research

CDER New Drug Review: 2013 Update, December 11, 2013

FDA/CMS Summit, John K. Jenkins, M.D., Director, Office of New Drugs Center for Drug Evaluation and Research

EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context, December 5, 2013

DIA EDM Webinar eCTD Update, Mark Gray, Director, Division of Data Management Services & Solutions

CDER Small Business Webinar on Guidance for Industry, November 18, 2013

ANDA Submissions – Refuse-to-Receive Standards, Johnny Young, Office of Generic Drugs (OGD)/CDER/FDA