Key Sessions
Karen Heraty
KEYNOTE PANEL: CTIS Experience, Obstacles, Challenges and Meeting RFI Timelines
Eli Lilly and Company
Christopher Pendleton
CASE STUDY Managing Company Confidential Information
Sarepta Therapeutics
keyboard_arrow_right
Search & Filter keyboard_arrow_right
keyboard_arrow_left Hide
Day One - CET (Central European Time, GMT+01:00)
keyboard_arrow_leftSearch & Filter
search
Streams
Day One - CET (Central European Time, GMT+01:00)
search
Streams
7:15am - 8:50am
Conference Registration
8:50am - 9:00am
Chairperson’s Opening Remarks
Showing 1 of 1 Streams
Redaction: Managing Enhanced Disclosure Obligations
9:00am - 9:50am
KEYNOTE PANEL: CTIS Experience, Obstacles, Challenges and Meeting RFI Timelines
- Karen Heraty - Executive Director, Clinical Trial Registry and Transparency, Global Scientific Communications, Eli Lilly and Company
- Megan Niner - Manager, Clinical Transparency and Data Disclosure, Arcus Biosciences
- Christopher Pendleton - Director, Global Regulatory Affairs, Disclosure and Transparency, Sarepta Therapeutics
9:50am - 10:25am
Resuming EMA Policy 70: Data Transparency Submissions Insight and Lessons Learnt
- Kali Tarascavage - Senior Manager, Clinical Transparency Lead, Otsuka
- Sanjay Bagani - VP, Clinical Trial Disclosures and Transparency, Xogene Services LLC
10:25am - 11:00am
CASE STUDY Navigating a First-Time Health Canada PRCI Submission: Learnings and Perspectives from Argenx and Privacy Analytics
11:00am - 11:30am
Networking Break
Showing 1 of 1 Streams
Registry & Results
11:30am - 12:05pm
ClinicalTrials.gov: From Modernization Efforts to Supporting Your Obligations
- Stacey Arnold - Results Subject Matter Expert for ClinicalTrials.gov, National Library of Medicine, National Institutes of Health
12:05pm - 12:40pm
Global Compliance: Updates on Additional Registry Requirements
12:40pm - 2:00pm
Networking Lunch
Showing 1 of 1 Streams
Protecting Data and Management of Company Confidential Information (CCI)
2:00pm - 2:35pm
CASE STUDY Managing Company Confidential Information
- Christopher Pendleton - Director, Global Regulatory Affairs, Disclosure and Transparency, Sarepta Therapeutics
2:35pm - 3:10pm
Anonymisation for Dummies
3:10pm - 4:00pm
Networking Break
Showing 1 of 1 Streams
Protecting Data and Management of Company Confidential Information (CCI)
4:00pm - 4:35pm
Protecting your Commercially Confidential Information (CCI) from an FDA Compliance Perspective
4:35pm - 5:15pm
Impact of Evolving EU Health Data Sharing Requirements on Transparency Efforts
- Julie Holtzople - Independent Consultant, Former Head of Clinical Transparency and Data Sharing at AstraZeneca
- Lora Killian - Clinical Trial Transparency and Disclosure Lead, Pfizer
5:15pm - 6:15pm
Close of Day One Followed by Networking Reception
Get the Latest Event Updates
Sign up to get the latest event updates and information.
Filter
Streams
Choose Day