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| Day | Session | Presentation Time | **TIMING CHECKPOINTS** | Presentation Title | Presenter Name | Reg. Type | Presentation in Sharepoint | Presenter Email | Presenter Mobile # | Presenter Organization |
|---|---|---|---|---|---|---|---|---|---|---|
| 10 June | 1 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:
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| 9:00 - 9:20 | 9:00 Message Bernard to START (Andrea) 9:18 2-minute end warning (Andrea) | Welcome Address & State of the CDISC Union | Dave Evans | CDISC Staff | Yes | devans@cdisc.org | +1-484-881-2411 | CDISC | ||
| 9:20 - 10:00 | 9:15 5-min start warning (Andrea) 9:55 5-min end warning (Andrea) | Keynote Presentation | Dr. Norio Ohmagari | Speaker Invited | Yes | nohmagari@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 Standards | Bess LeRoy | CDISC Staff | Yes | bleroy@cdisc.org | +1-520-237-8689 | CDISC | ||
2 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 Reusel | CDISC Staff | No | pvanreusel@cdisc.org | +32 476 545 917 | CDISC | |
| 11:40 - 12:10 | 11:35 5-min start warning (Andrea) 12:05 5-min end warning (Andrea) | CDISC Library Update | Anthony Chow | CDISC Staff | Yes | achow@cdisc.org | +1-267-978-7709 | CDISC | ||
| 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 Library | Alana St. Clair | CDISC Staff | Yes | astclair@cdisc.org | +1 512 773 5907 | CDISC | ||
3 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 | Yuki: +81-90-8104-7303 | PMDA | ||
| 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 CDISC | Yasutaka Moriguchi and Natsumi Kawase | Platinum Member Speaker | Yes | 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 Riddle | Arvind Sri Krishna Mani | Speaker | Yes | arvind.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 Discussion | Dr. Jozef Aerts | Speaker | Yes | Jozef.Aerts@XML4Pharma.com | +43-6818-1512436 | XML4Pharma | ||
4 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 Techniques | Will Greenway and Joel Clarke | Speaker Gold Member | Yes | 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 Presentation | Frank Pétavy | Speaker Invited | Yes | Frank.Petavy@ema.europa.eu | +31628561224 | |||
| 17:30 | 17:30 End of Day 1 Wrap-Up Play rolling slides (Bernard) | End of Day 1 Wrap-Up | Akira Soma | |||||||
| 11 June | 5 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:
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| 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 | No | Helena.Sviglin@fda.hhs.gov | +1-205-910-4522 | FDA-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 issues | Jesse Anderson | Speaker Invited | Yes | Jesse.Anderson@fda.hhs.gov | +1-202-365-9157 | FDA-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 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 Studies | William Houser | Speaker | Yes | william.houser@bms.com | +1 812 550-2162 | Bristol 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 Python | Hengwei Liu | Speaker | Yes | hengwei_liu@yahoo.com | 1-732-668-4584 | Daiichi 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 Submissions | Yiyuan Ma | Speaker | Yes | Yiyuan.Ma@sanofi.com | wechat number is mayiyuan5007x | Sanofi | ||
7 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 Conversion | Miu Susuki | Speaker | Yes | miu.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 Haneji | Speaker | Yes | Hiroshi.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. Saito | J3C | Yes | toshiki.saito@nnh.go.jp | +81-90-3045-7898 | NHO Nagoya Medical Center | ||
8 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 Presentation | John Owen | CDISC Staff | Yes | jowen@cdisc.org | +44 7956 929 228 | CDISC | |
| 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&A | Peter Van Reusel | CDISC Staff | No - Andrea to create | pvanreusel@cdisc.org | +32 476 545 917 | CDISC | ||
| 16:45 - 16:50 | 16:40 5-min start warning (Andrea) | Final Remarks from the CDISC Board | Dr. Hiroshi Masumoto | CDISC Board | masumoto.hiroshi.e7@daiichisankyo.co.jp | +81 8049001845 | Daiichi Sankyo, CDISC Board Member | |||
| 16:50 - 17:00 | 16:45 5-min start warning (Andrea) | Closing Remarks | Akira Soma | J3C | No | akira.soma@oracle.com | +81 8081955162 | Oracle, J3C Chair | ||
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