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DaySessionPresentation Time

**TIMING CHECKPOINTS**

Presentation TitlePresenter Name

Reg.

Type

Presentation in SharepointPresenter EmailPresenter Mobile #Presenter Organization
10 June













1
9:00 - 10:40

Session Chair:

Akira Soma akira.soma@oracle.com

+81 8081955162


Pre-Conference

8:00 Begin Webinar in Practice Mode (Bernard)

8:59 Countdown to pushing Broadcast button - Show Session 1 slide (Bernard)

During Practice Mode:

  1. Double check interpretation 
  2. sure "Allow Panelist Start Video" is checked
  3. From the "Chat" window, make sure "Allow attendees to chat with: NO ONE" is checked
  4. Remind about staying muted unless speaking
  5. Remind about not using chat
  6. Double check all speakers' microphones and screen share
9:00 - 9:20

9:00 Message Bernard to START (Andrea)

9:18 2-minute end warning (Andrea)

Welcome Address & State of the CDISC UnionDave EvansCDISC StaffYesdevans@cdisc.org+1-484-881-2411CDISC
9:20 - 10:00

9:15 5-min start warning (Andrea)

9:55 5-min end warning (Andrea)

Keynote PresentationDr. Norio OhmagariSpeaker InvitedYesnohmagari@hosp.ncgm.go.jp
Lead, COVID-19 registration program, National Center for Global Health and Medicine
10:00 - 10:40

9:55 5-min start warning (Andrea)

10:35 5-min end warning (Andrea)

10:40 Play rolling slides (Bernard)

State of CDISC StandardsBess LeRoyCDISC StaffYesbleroy@cdisc.org+1-520-237-8689CDISC

2
11:10 - 12:40

Session Chair:

Dr. Takuhiro Yamaguchi yamaguchi@med.tohoku.ac.jp

+81 (0)90 8941 6354

11:10 - 11:40

PRE-RECORDED PRESENTATION

11:05 5-min start warning to Dr. Yamaguchi (Andrea)

11:35 5-min end warning to Dr. Yamaguchi (Andrea)

CDISC 360 Update (Pre-Recorded)Peter Van ReuselCDISC StaffNopvanreusel@cdisc.org+32 476 545 917CDISC
11:40 - 12:10

11:35 5-min start warning (Andrea)

12:05 5-min end warning (Andrea)

CDISC Library UpdateAnthony ChowCDISC StaffYesachow@cdisc.org+1-267-978-7709CDISC
12:10 - 12:40

12:05 5-min start warning (Andrea)

12:35 5-min end warning (Andrea)

12:40 Play rolling slides (Bernard)

CRF LibraryAlana St. ClairCDISC StaffYesastclair@cdisc.org+1 512 773 5907CDISC

3
13:40 - 15:50

Session Chair:

Dr. Hideto Yokoi yokoi@med.kagawa-u.ac.jp

13:40 - 14:20

13:35 5-min start warning (Andrea)

14:15 5-min end warning (Andrea)

PMDA Update

Dr. Yuki Ando

Dr. Daisuke Iwata

Speaker Invited

Speaker Invited

Yes

ando-yuki@pmda.go.jp 

iwata-daisuke@pmda.go.jp

Yuki: +81-90-8104-7303PMDA
14:20 - 14:50

14:15 5-min start warning (Andrea)

14:45 5-min end warning (Andrea)

Enhancement of the Role of Clinical Programming in the age of CDISCYasutaka Moriguchi and Natsumi Kawase

Platinum Member

Speaker

Yes

yasutaka.2.moriguchi@gsk.com

natsumi.2.kawase@gsk.com

Yasutaka:+81-80-5447-1749

Natsumi: +81 90-9549-9605

GlaxoSmithKline K.K. 
14:50 - 15:20

14:45 5-min start warning (Andrea)

15:15 5-min end warning (Andrea)

Simplifying the Integration RiddleArvind Sri Krishna ManiSpeakerYesarvind.m@zifornd.com+91 98945 46153 (India - Mobile)Zifo RnD Solutions
15:20 - 15:50

15:15 5-min start warning (Andrea)

15:45 5-min end warning (Andrea)

15:50 Play rolling slides (Bernard)

Submitting Data with Japanese Characters to PMDA: The UTF-8 and Other Encodings DiscussionDr. Jozef AertsSpeakerYesJozef.Aerts@XML4Pharma.com+43-6818-1512436XML4Pharma

4
16:20 - 17:30

Session Chair:

Dr. Yuki Ando ando-yuki@pmda.go.jp 


16:20 - 16:50

16:15 5-min start warning (Andrea)

16:45 5-min end warning (Andrea)

The Age Old Problem: A Discussion of Age Derivation and Imputation TechniquesWill Greenway and Joel Clarke

Speaker

Gold Member

Yes

will.greenway@quanticate.com

joel.clarke@quanticate.com

Will: +447578143263

Joel: +447536115511.

Quanticate International, LTD
16:50 - 17:30

16:45 5-min start warning (Andrea)

17:25 5-min end warning (Andrea)

EMA PresentationFrank PétavySpeaker InvitedYesFrank.Petavy@ema.europa.eu+31628561224
17:30

17:30 End of Day 1 Wrap-Up

Play rolling slides (Bernard)

End of Day 1 Wrap-UpAkira Soma




11 June

5
9:00 - 10:30

Session Chair:

Dr. Toshiki Saito toshiki.saito@nnh.go.jp

Pre-Conference

8:00 Begin Webinar in Practice Mode (Bernard)

8:59 Countdown to pushing Broadcast button (Bernard)

During Practice Mode:

  1. Double check interpretation 
  2. sure "Allow Panelist Start Video" is checked
  3. From the "Chat" window, make sure "Allow attendees to chat with: NO ONE" is checked
  4. Remind about staying muted unless speaking
  5. Remind about not using chat
  6. Double check all speakers' microphones and screen share
9:00 - 9:30

9:00 Message Saito-sensei to START (Andrea)

Saito-sensei welcomes back everyone to Day 2 of the conference. Introduces Helena.

9:25 5-minute end warning (Andrea)

Policy Frameworks for Submitting Study Data to FDA

Helena Sviglin

Speaker Invited 

NoHelena.Sviglin@fda.hhs.gov+1-205-910-4522FDA-CDER
9:30 - 10:00

9:25 5-min start warning (Andrea)

9:55 5-min end warning (Andrea)

CDER's experience with ADaM traceability assessment and common data quality issuesJesse Anderson

Speaker Invited

YesJesse.Anderson@fda.hhs.gov+1-202-365-9157FDA-CDER
10:00 - 10:30

9:55 5-min start warning to Saito-sensei (Andrea)

10:25 5-min end warning to Saito-sensei (Andrea)

10:30 Play rolling slides (Bernard)

Q&A Session

N/A


6
11:00 - 12:30

Session Chair:

Dr. Hideto Yokoi yokoi@med.kagawa-u.ac.jp

11:00 - 11:30

10:55 5-min start warning (Andrea)

11:25 5-min end warning (Andrea)

Utilizing CDISC SEND Data to Generate Historical Control Incidence from a Large Database of Toxicology StudiesWilliam HouserSpeakerYeswilliam.houser@bms.com+1 812 550-2162Bristol Myers Squibb/BioCelerate
11:30 - 12:00

11:25 5-min start warning (Andrea)

11:55 5-min end warning (Andrea)

Create the Define.XML v2.1 with PythonHengwei LiuSpeakerYeshengwei_liu@yahoo.com1-732-668-4584Daiichi Sankyo, Inc.
12:00 - 12:30

11:55 5-min start warning (Andrea)

12:25 5-min end warning (Andrea)

12:30 Play rolling slides (Bernard)

NMPA SubmissionsYiyuan MaSpeakerYesYiyuan.Ma@sanofi.comwechat number is mayiyuan5007xSanofi

7
13:30 - 15:00

Session Chair:

Hideaki Kosaka hideaki.kosaka.z9@croit.com

13:30 - 14:00

12:25 5-min start warning (Andrea)

13:55 5-min end warning (Andrea)

Use Cases Report on Integrated Analysis and Legacy Data ConversionMiu SusukiSpeakerYesmiu.susuki@ppd.com

+8190-1599-1994

JCROA
14:00 - 14:30

13:55 5-min start warning (Andrea)

14:25 5-min end warning (Andrea)

Global Reg Submission
Challenges in submitting CDISC datasets to multiple regulatory agencies – toward a new stage of standards –
Hiroshi HanejiSpeakerYesHiroshi.Haneji@sanofi.com

+81-80-9549-4572

JPMA CDISC Taskforce Representative
14:30 - 15:00

14:25 5-min start warning (Andrea)

14:55 5-min end warning (Andrea)

15:00 Play rolling slides (Bernard)

Gap Analysis of CDISC Standards Implementation in Academia and CDISC-Annotated CRF Repository in Japan (AMED project)Dr. Toshiki I. SaitoJ3CYestoshiki.saito@nnh.go.jp+81-90-3045-7898NHO Nagoya Medical Center

8
15:30 - 17:00

Session Chair:

Hidemi Hasegawa hidemi.hasegawa@boehringer-ingelheim.com

15:30 - 16:00

15:25 5-min start warning (Andrea)

15:55 5-min end warning (Andrea)

CDISC PresentationJohn Owen

CDISC Staff

Yesjowen@cdisc.org +44 7956 929 228CDISC
16:00 - 16:45

15:55 5-min start warning to Peter (Andrea)

16:40 5-min end warning to Peter and John O. (Andrea)

CDISC Q&APeter Van ReuselCDISC StaffNo - Andrea to createpvanreusel@cdisc.org +32 476 545 917CDISC
16:45 - 16:50

16:40 5-min start warning (Andrea)

Final Remarks from the CDISC BoardDr. Hiroshi MasumotoCDISC Board
masumoto.hiroshi.e7@daiichisankyo.co.jp+81 8049001845Daiichi Sankyo, CDISC Board Member
16:50 - 17:0016:45 5-min start warning (Andrea)Closing RemarksAkira SomaJ3CNoakira.soma@oracle.com+81 8081955162Oracle, J3C Chair

...