GlobalSubmit is pleased to provide you with access to recent agency presentations, since this is such an important means of keeping up to date with guidance and advice. We will continue to add presentations as they become available.
DIA 2012 Annual Meeting, Philadelphia, PA June 27, 2012
- The State of Electronic Submissions at CDER, Virginia Hussong, Office of Business Informatics, OPI, CDER
- eCTD Module 1 Update Part 1, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Informatics, OPI, CDER
- eCTD Module 1 Update Part II, Mark Gray, Director, Division of Regulatory Review Support, Office of Business Informatics, CDER
- Draft Module 1 Update, 1.15 Promotional Materials, Marci Kiester, Pharm D, Associate Director of Operations, OPDP, CDER
Pharmaceutical Regulatory Writing & Submissions Conference Baltimore, MD May 14-15, 2012
DIA Module 1 Townhall, February 9, 2012
- eCTD M1 Update: General Overview of the Comments, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Process Support, CDER
- Draft Module 1 Update (1.15 Promotional Materials), Marci Kiester, Pharm D, Associate Director of Operations, OPDP (formerly DDMAC), CDER
- Key Modifications to Module 1, Jared Lantzy, Regulatory Information Specialist, Electronic Submission Support Team, Office of Business Informatics
DIA Electronic Submissions: The 10th Anniversary Conference San Diego, CA November 15-17, 2011
- Electronic Submissions Update, Virginia Hussong, Office of Prescription Drug Promotion (OPDP), CDER
- Update on Data Standards in CDER, Chuck Cooper, MD, Office of Translational Science, CDER
- OPDP Submissions: Current process and What's Ahead, Marci Kiester, PharmD, Associate Director of Operations, OPDP, CDER
- eCTD Module 1 Update, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Process Support, CDER
Electronic Common Technical Document (eCTD): Additional Module 1 Update, Mark Gray, Director, Division of Regulatory Review Support, Office of Business Informatics, CDER
DIA's 24th Annual Conference on Electronic Document Management National Harbor, MD February 15-16, 2011
- eCTD Validation Update, Jared Lantzy, Electronic Submission Support Team, Office of Business Informatics, CDER
- CDRH: Current and Future Uses of Data Standards in eSubmissions, Terrie L. Reed, MSIE, Associate Director Informatics
- Regulatory Update: Session 2 CDER Data Standards Plan, Catherine Jansto, RN MS, Project Manager, Office of Planning & Analysis, CDER, FDA
- The Changing Landscape for Nonclinical Data, Timothy Kropp, Ph.D., Toxicologist, CDER, FDA
Regulated Product Submission (RPS) and Module 1 Update, Mark Gray, Director, Division of Regulatory Review Support FDA/CDER/OBI
DDMAC Submissions, Marci Kiester, PharmD, CDR, USPHS, Associate Director of Operations, Division of Drug Marketing, Advertising, and Communications
DIA Annual Meeting, Washington DC, June 14-17, 2010
- The Application of Data Standards, Gary Gensinger, Deputy Director, Office of Business Process Support, CDER
- FDA International Update, Gary Gensinger, Deputy Director, Office of Business Process Support, CDER
- CTD/eCTD Quality: FDA Survey Results, Dr. Sarah Connolly, Medical Officer, Division of Antiviral Products, FDA
- Regulated Product Submission: eCTD Next Major Version, Mark Gray Director, Division of Regulatory Review Support, FDA/CDER/OBPS
- A CMC Reviewer’s Perspective on the Quality Overall Summary and Module 3, Arthur B. Shaw, Ph.D.
FDA/CDER/ONDQA, FDA DMF Expert
- eCTD: A Clinical Reviewer’s Experience, Dr. Sarah Connolly, Medical Officer, Division of Antiviral Products, FDA
- STUDY TAGGING FILES: THEIR VITAL ROLE IN SUBMISSIONS TO THE FDA, Virginia Ventura Hussong
Supervisor, Electronic Submission Support Team, Office of Business Informatics, Office of Planning and Informatics, CDER�
- CDER's Data Standards Program, Ranjit Thomas, Operations Research Analyst, CDER
GPhA/FDA Labeling Workshop, North Bethesda, MD, April 14th, 2010
CDER Update eCTD & Gateway Submissions, Virginia Ventura, Team Lead, Electronic Submission Support, Office of Business Informatics, Office of Planning and Informatics, CDER, FDA
The 23rd Conference on Electronic Document Management National Harbor, MD February 16th through 19th
- eCTD Experiences and Recommendation – An FDA User Perspective, Michael Folkendt, Associate Director for Regulatory Affairs & Supervisory Project Manager, Office of New Drug Quality Assessment OPS, CDER, FDA
- CDER 21st Century Review, Daniel Brum, PharmD, MBA, RAC, FDA, CDER, Office of New Drugs, Division of Cardiovascular and Renal Products, FDA�
- Clinical Trial Data to support CDER Application Review, Chuck Cooper, M.D., Office of Translational Sciences, CDER, FDA
- e-SUBMISSIONS: A Clinical Reviewer’s Perspective, Christine P. Nguyen, M.D. Office of New Drugs, FDA
- Study Tagging Files: Their Vital Role in Submissions to the FDA, Virginia Ventura Supervisor, Electronic Submission Support Team, Office of Business Informatics, Office of Planning and Informatics, CDER, FDA
- Regulatory Update Future Directions: CDER Data Standards Plan, Marni Hall, PhD, MPH, Principal Analyst Office of Planning & Analysis, CDER, FDA
- Computational Science Center Update, Chuck Cooper, MD, FDA
- Regulated Product Submission (RPS), Mark Gray FDA/CDER/OBPS Director, Division of Regulatory Review Support, FDA
The 10th Conference on European Electronic Document Management
Vienna, Austria, December 4th and 5th, 2009
The 8th Annual Electronic Submissions Conference “eCTD: The Adventure Continues”
San Diego, November 18th and 19th, 2009
- FDA eInitiatives: An update on Regulatory Authority Experience, Gary M Gensinger, MBA, Deputy Director, Office of Business Informatics, CDER
- Study Tagging Files: Their Vital Role In Submissions to the FDA, Virginia Ventura, Electronic Submission Support Team, Office of Business Informatics, Office of Planning and Informatics, CDER
- FDA Data Standards: An Update, Lilliam Rosario, Ph.D., Associate Director, Office of Critical Path Programs, Office of the Commissioner
- Computational Science and Data Standards in CDER, Chuck Cooper, M.D., Office of Translational Sciences, CDER
The 45th DIA Annual Electronic Submissions Meeting
San Diego, June 22nd through 25th, 2009
- International eCTDs: An update on Regulatory Authority Experience, Gary M Gensinger, MBA, Deputy Director, Office of Business Informatics, CDER
- PDUFA IV Update, Gary M Gensinger, MBA, Deputy Director, Office of Business Informatics, CDER
- The Properly Formatted eCTD: Examples and Practical Advice, Virginia Ventura, Electronic Submission Support Team, Office of Business Informatics, Office of Planning and Informatics, CDER
- CDER eSubmission Update: Regulated Product Submission (RPS) Update, Mark Gray, Director, Division of Regulatory Review Support, CDER/OBPS
- e-SUBMISSIONS: A Clinical Reviewer’s Perspective, Christine P. Nguyen, M.D.
- Chemistry Reviewer's Perspective of the eCTD, Mark R. Seggel, ONDQA/CDER
TOPRA
April, 2009
Strategic Management of CMC Dossiers in the eCTD Format
Baltimore, March 10 -11, 2009
- Benefits and Challenges of eCTD: FDA Perspective, Norman Schmuff, Branch Chief, Office of New Drug Quality Assessment, CDER
- eCTD Post Approval CMC Aspects: FDA Perspective, Hasmukh B. Patel, Ph.D. ONDQA, CDER
- Strategic Management of CMC Dossiers in the eCTD Format: What CMC Professionals Need to Know Now Gary M Gensinger, MBA, Deputy Director, Office of Business Informatics, CDER
The 22nd Conference on Electronic Document Management
Philadelphia, February 11th through 13th, 2009
- International Update: 22nd Annual Electronic Document Management, Gary M Gensinger, MBA, Deputy Director, Office of Business Informatics, CDER
- CDER eCTD & Validation Issues Update, Virginia Ventura, Team Lead, Electronic Submission Support, CDER
- eCTD: The Project Management Perspective, Dave Roeder, Associate Director for Regulatory Affairs, CDER
- e-SUBMISSIONS: A Clinical Reviewer’s Perspective, Olivia Easley, M.D.
- Regulated Product Submissions, Mary P. Padgett, CDER
For earlier presentations, see the postings on the FDA’s website.