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SpeakerSession ChairScript
Session 1
Bernard KlinkeAkira Soma

Welcome to the Virtual 2021 CDISC Japan Interchange. I am Akira Soma, CDISC J3C Chair. As we get started today, I am going to ask that Bernard Klinke, CDISC Virtual Experiences Manager, provide some important housekeeping information for Zoom Webinar and Slack. Bernard, please go ahead and begin.
Dave Evans

Thank you, Bernard. Our first speaker today will be Mr. Dave Evans, CDISC President and CEO, who will be presenting the Welcome Address & State of the CDISC Union.

<Akira: please read Dave's biography here.>

Dave, please begin when you are ready.

Dr. Norio Ohmagari

Thank you, Dave, for your presentation. We will now move on to our Keynote presentation. Our Keynote speaker will be Dr. Norio Ohmagari, Lead, COVID-19 registration program, National Center for Global Health and Medicine. 

<Akira: please read Dr. Ohmagari's biography here.>

Dr. Ohmagari, please begin when you are ready.

Thank you, Dr. Ohmagari, for that excellent Keynote presentation. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Bess LeRoy

Thank you, Dr. Ohmagari. Our next speaker will be Bess LeRoy, CDISC Head of Standards Development, who will present the State of CDISC Standards. Bess, please begin your presentation when you are ready.

Thank you, Bess, for this excellent update. We will now have Q&A. (only if time allows, and only if we have questions).

After Bess

Thank you, Bess, for your presentation. Everyone, we will now take a break, and will return at 11:10 AM Japan Time. During this time, we encourage you to visit our sponsors and exhibitors in the CDISC Events Slack Space, and participate in the Virtual Scavenger Hunt! Please also leave your questions for our speakers in their topic channels.

(Bernard will then play rolling slides, followed by the Session 2 slide, until the start of the next session)

Session 2
Peter Van ReuselDr. Takuhiro Yamaguchi

Welcome back after the break. I am Takuhiro Yamaguchi, J3C member. I would like to introduce our next speaker, Peter Van Reusel, CDISC Chief Standards Officer, who will be providing a recorded version of the CDISC 360 Update. Attendees, please note that if you have any questions for Peter, he will answer them live during the CDISC Q&A during Session 8, Closing Plenary tomorrow. Please add any questions you have to the Session 8 Slack Channel. 

Bernard, please begin the presentation. (Bernard will begin the pre-recorded presentation).

Anthony Chow

Thank you. We will now move on to our next presentation. Our next speaker will be Anthony Chow, CDISC Director of Data Science. He will be presenting an update on the CDISC Library. Anthony, please begin when you are ready.

Thank you, Anthony, for this excellent update. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Alana St. Clair

Thank you Anthony, for your informative presentation. Our next speaker will be Alana St. Clair, CDISC Project Manager. She will be presenting on the CDASH eCRF Portal. Alana, please begin when you are ready.

Thank you, Alana, for this excellent update. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

After Alana

Thank you, Alana. Everyone, we will now break for lunch, and will return at 13:40 PM Japan Time. During this time, we encourage you to visit our sponsors and exhibitors, and participate in the Virtual Scavenger Hunt! Please also leave your questions for our speakers in their topic channels.

(Bernard will then play rolling slides, followed by the Session 3 slide, until the start of the next session)

Session 3

Dr. Yuki Ando

Dr. Daisuke Iwata

Dr. Hideto Yokoi

Welcome back after lunch, everyone. I am Hideto Yokoi, J3C member. Our next speakers will be Dr. Yuki Ando, Senior Scientist for Biostatistics at PMDA, and Dr. Daisuke Iwata, Senior Reviewer at PMDA.

<Yokoi-sensei, please read bios for Drs. Ando and Iwata here>.

Drs. Ando and Iwata will will be providing an update from the PMDA. Drs. Ando and Iwata, please begin when you are ready.

Thank you, Drs. Ando and Iwata, for this excellent update. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Yasutaka Moriguchi and Natsumi Kawase

Thank you, Drs. Ando and Iwata, for your presentation. We will now move on to our next presentation. Our next speakers are Yasutaka Moriguchi and Natsumi Kawase of GlaxoSmithKline K.K. They will be presenting Enhancement of the Role of Clinical Programming in the Age of CDISC. Yasutaka and Natsumi, please begin when you are ready.

Thank you, Yasutaka and Natsumi. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Arvind Sri Krishna Mani

Thank you, Yasutaka and Natsumi, for your presentation. We will now move to the next presentation. The next speaker today will be Arvind Sri Krishna Mani of Zifo RnD Solutions. He will be presenting Simplifying the Integration Riddle. Arvind, please begin when you are ready.

Thank you, Arvind. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Dr. Jozef Aerts

Thank you, Arvind, for your presentation. We will now move to our next presentation. Our next presenter will be Dr. Jozef Aerts of XML4Pharma. He will be presenting Submitting Data with Japanese Characters to PMDA: The UTF-8 and Other Encodings Discussion. Dr. Aerts, please begin when you are ready.

Thank you, Dr. Aerts. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

After Jozef

Thank you, Dr. Aerts, for your presentation. Everyone, we will now take a break, and will return at 16:20 PM Japan Time. During this time, we encourage you to visit our sponsors and exhibitors, and participate in the Virtual Scavenger Hunt! Please also leave your questions for our speakers in their topic channels.

(Bernard will then play rolling slides, followed by the Session 4 slide, until the start of the next session)

Session 4
Will Greenway and Joel ClarkeDr. Yuki Ando

Welcome back from the break, everyone, I am Yuki Ando, Senior Scientist for Biostatistics at the PMDA. I would like to introduce our next speakers, Will Greenway and Joel Clarke, of Quanticate International Ltd. Will and Joel will be presenting The Age Old Problem: A Discussion of Age Derivation and Imputation Techniques. Will and Joel, please begin when you are ready.

Thank you, Will and Joel. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Dr. Frank Pétavy

Thank you, Will and Joel, for your presentation. Our final speaker today will be Dr. Frank Pétavy, Head of Methodology, Data Analytics and Methods Task Force at the European Medicines Agency. Dr. Pétavy will be presenting HMA – EMA Joint Big Data Task Force:  From recommendation to implementation

<Dr. Ando, please read bio for Dr. Frank Pétavy here>.

Dr. Pétavy, please begin when you are ready.

Thank you, Dr. Pétavy. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

After FrankAkira Soma

Thank you, Dr. Pétavy, for your excellent presentation. This concludes the presentations for the first day of the Virtual Japan Interchange. As a reminder, our Slack Networking Space remains available throughout the conference for you to continue networking with your colleagues and peers, and to ask questions about the presentations in our topic channels. We will begin our second day of the conference promptly at 9:00 AM Japan Time tomorrow. Thank you, everyone.

(Bernard will then play rolling slides. After rolling slides play, Bernard will end the webinar for the day)

Session 5
Helena SviglinDr. Toshiki Saito

Welcome back everyone, to Day 2 of the Virtual CDISC Japan Interchange. I am Toshiki Saito, J3C Member. We will begin today with presentations from participants from the FDA. Attendees, please note that we will hold Q&A after our second presenter during this session. Please add your questions for Q&A to the Session 5 Slack channel.

Our first speaker today is Helena Sviglin, of the Office of Strategic Program at FDA-CDER.

<Dr. Saito, please read Helena's biography here>

Helena will be presenting POLICY FRAMEWORKS FOR SUBMITTING STUDY DATA TO FDA. Helena, please begin when you are ready.

Jesse Anderson

Thank you, Helena, for your informative presentation. Attendees, as a reminder, we will hold Q&A after our second presenter during this session. Please add your questions for Q&A to the Session 5 Slack channel.

We will now move on to our next presentation. Our next presenter is Jesse Anderson, Lead, Data Standards and JumpStart Service at FDA CDER.

<Dr. Saito, please read Jesse's biography here>

Jesse will be presenting CDER’S EXPERIENCE WITH THE ADAM TRACEABILITY ASSESSMENT AND COMMON DATA QUALITY ISSUES. Jesse, please begin when you are ready.

Q&A

Thank you, Jesse. We will now have Q&A with both our presenters, Helena and Jesse. (Please check the Slack channel for all Q&A for Helena and Jesse).

Thank you to our panelists and to those who submitted questions. Any questions that could not be answered will be sent forward to our presenters, and may be answered in Slack.

After Q&A

Everyone, we will now take a break, and will return at 11:00 AM Japan Time. During this time, we encourage you to visit our sponsors and exhibitors, and participate in the Virtual Scavenger Hunt! As a reminder, you must submit your responses to the Scavenger Hunt survey no later than the end of the second break for your chance to be entered into our prize drawing! Please also leave your questions for our speakers in their topic channels. The CDISC Q&A will be held at the end of the day today, so make sure to add your question to our CDISC Q&A channel in Slack to participate!

(Bernard will then play rolling slides, followed by the Session 6 slide, until the start of the next session)

Session 6
William HouserDr. Hideto Yokoi

Welcome back from the break, everyone. I am Hideto Yokoi, J3C Member. Our next presenter will be William Houser of Bristol Myers Squibb / BioCelerate, who will present Utilizing CDISC SEND Data to Generate Historical Control Incidence from a Large Database of Toxicology Studies. William, please begin when you are ready.

Thank you, William. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Hengwei Liu

Thank you, William, for your presentation. We will now move on to our nest presentation. Our next presenter will be Hengwei Liu of Daiichi Sankyo, Inc. Hengwei will be presenting Create the Define.XML v2.1 with Python. Hengwei, please begin when you are ready.

Thank you, Hengwei. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Yiyuan Ma

Thank you, Hengwei, for your presentation. We will now move on to our nest presentation. Our next presenter will be Yiyuan Ma of Sanofi. Yiyuan will be presenting NMPA Submissions. Yiyuan, please begin when you are ready.

Thank you, Yiyuan. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

After Yiyuan

Thank you, Yiyuan, for your presentation. Everyone, we will now break for lunch, and will return at 13:30 PM Japan Time. During this time, we encourage you to visit our sponsors and exhibitors, and participate in the Virtual Scavenger Hunt! As a reminder, responses to the Scavenger Hunt Survey are due by the end of the second break to be considered for our prize drawing! Please also leave your questions for our speakers in their topic channels. The CDISC Q&A will be held at the end of the day today, so make sure to add your question to our CDISC Q&A channel in Slack to participate! We will only accept questions for the CDISC Q&A through the end of lunch.

(Bernard will then play rolling slides, followed by the Session 7 slide, until the start of the next session)

Session 7
Miu SusukiHideaki Kosaka

Welcome back from lunch, everyone. I am Hideaki Kosaka, J3C Member. Our next presenter will be Miu Susuki of the JCROA. She will be presenting Use Cases Report on Integrated Analysis and Legacy Data Conversion. Miu, please begin when you are ready.

Thank you, Miu. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Hiroshi Haneji

Thank you, Miu, for your presentation. Our next presenter will be Hiroshi Haneji of Sanofi and JPMA. Hiroshi will be presenting Challenges in Submitting CDISC Datasets to Multiple Regulatory Agencies: Toward a New Stage of Standards. Hiroshi, please begin when you are ready.

Thank you, Hiroshi. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

Dr. Toshiki I. Saito

Thank you, Hiroshi, for your presentation. Our next presenter will be Dr. Toshiki I. Saito, of NHO Nagoya Medical Center. Dr. Saito will be presenting Gap Analysis of CDISC Standards Implementation in Academia and CDISC-Annotated CRF Repository in Japan (AMED project). Dr. Saito, please begin when you are ready.

Thank you, Dr. Saito. We will now have Q&A. (only if time allows, and only if we have questions. Please check the Slack channel).

After Dr. Saito

Thank you, Dr. Saito, for your presentation. Everyone, we will now take a break, and will return at 15:30 PM Japan Time. Please remember to visit our sponsors and exhibitors, and network with your colleagues and peers! As a reminder, responses to the Scavenger Hunt Survey are due by the end of the second break to be considered for our prize drawing!

(Bernard will then play rolling slides, followed by the Session 8 slide, until the start of the next session)

Session 8
John OwenHidemi Hasegawa

Welcome back from the break, everyone. We will now begin our final session of the day. Attendees, please note that all questions for our first presenter will be addressed during the CDISC Q&A, immediately following this presentation. Our first presenter will be John Owen, CDISC Head of Business Development. 

<Hidemi, please read John's biography here.>

John will be presenting Expanding the Use of CDISC Standards​ into Academic Research. John, please begin when you are ready.

Peter Van Reusel and John Owen

Thank you, John, for your presentation. We will now move into the CDISC Q&A portion of the event. 

Both John Owen and Peter Van Reusel, CDISC Chief Standards Officer, have joined us today to answer questions on behalf of CDISC. Thank you to everyone that provided questions in the CDISC Q&A channel for this part of the conference. Please understand that due to time limitations, we will likely not get to everyone's question, but the Slack Networking Space will be available for two weeks following the conference, so I am sure that we will get to most questions. Peter and John, are you ready to begin?

<Bernard will show the CDISC Q&A slides. Hidemi will let Bernard know when to advance to the next slide, after the question is answered>

Dr. Hiroshi Masumoto

Thank you, Peter and John, for providing such thoughtful answers to these questions. Everyone, any additional questions will be addressed through the Slack Networking Space. I would now like to introduce our next speaker, Dr. Hiroshi Masumoto of Daiichi Sankyo and the CDISC Board of Directors, who will give final remarks on behalf of the CDISC Board. Dr. Masumoto, please begin when you are ready.

Akira Soma

Thank you, Dr. Masumoto. This now concludes the second day of the Virtual CDISC Japan Interchange. We would like to thank first and foremost all of our J3C members for their tireless efforts in making this second Virtual Japan Interchange a success. Additionally, we would like to thank all of the speakers who presented on multiple time zones from across the world. Also, we would like to thank our Sapphire Sponsor, Zifo RnD Solutions and our exhibitors for their continued dedication to this conference - thank you so much.

(Bernard will then play rolling slides. After rolling slides play, Bernard will end the webinar for the day)

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