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DAY ONE Tuesday, 11 June 2019

8:00

Conference Check-In and Welcome Refreshments

9:00

Chairman’s Opening Remarks

Neil Garrett
Global Head, Regulatory Medical Writing
Janssen

Review Regulatory Shifts and
Anticipated Changes for
Clinical Trial Data Requirements

9:15

Navigate HRA Requirements for Clinical Trial Transparency

Amanda Hunn
Principal, A J Hunn Associates;
former Head of Policy, Health Research Authority

10:05

Explore Recent Trends and Innovations in Data Sharing and Transparency

Thomas Wicks
Chief Strategy Officer
TrialScope

10:55

Networking and Refreshment Break

11:25

Dissect the Impact of the FDA Monetary Penalty Rule

Jo Anne Marie Blyskal
Head of Medical Writing & Clinical Trial Disclosure
Teva

12:15

Networking Luncheon

13:30

Writing for Our Audiences —
Develop Lean CSRs to Facilitate Regulatory Review and Limit Redactions

Joan Affleck
Executive Director, Head of Medical Writing
Merck

From the Theoretical to the Practical —
Deconstruct Roadblocks to
Results Posting and Data Anonymisation

14:15

PANEL DISCUSSION Share Challenges and Lessons Learned in Global Clinical Trial Data Disclosure

MODERATOR:

Jo Anne Marie Blyskal
Head of Medical Writing & Clinical Trial Disclosure
Teva

PANELISTS:

Kelly DiGian
Director, Data Transparency & Disclosure
Teva

Sybille Eibert
Associate Director, Transparency & Disclosure
Teva

Neil Garrett
Global Head, Regulatory Medical Writing
Janssen

15:15

Networking and Refreshment Break

15:45

INTERACTIVE WORKSHOP
Move Beyond the Quantification of Data Anonymisation

Participants gain a high-level understanding of the quantitative principles of data anonymisation and how to apply those to creating a report for both data sets and documents.

I. Learn the Basics of the Quantitative Approach

II. Review Technical Anonymisation Group (TAG) Initiatives and Progress

III. Quantify the Risk

IV. Develop Cohesive Data Anonymisation Reports

Workshop Leader:

Lukasz Kniola
Principal Analyst, Data Sharing
Biogen

17:15

Close of Day One

Please Join Us! Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Wednesday, 12 June 2019

8:00

Morning Refreshments

8:45

CHOOSE BETWEEN TWO BREAKOUTS (I-II)

BREAKOUT I CLINICAL DATA TRANSPARENCY Breaking Through Barriers
to Achieve Excellent
Disclosure Practices

Navigate Current and Future Requirements Related to Patient Level Data Sharing (PLDS)

Sophie Buyle
Project Manager, Web Disclosure
GSK

 
BREAKOUT II PUBLICATIONS Connecting New Developments
in Medical Publications with Strategies for Success

 

Innovations in Publications — Decipher Trends on Pre-Prints, Digital Publications, Open Access Policies and Plain Language Summaries

Susan Wieting
Director, Scientific Publications
Shire International GmbH,
now part of Takeda, Zug, Switzerland

9:30

CASE STUDY Build a Positive Public Data Transparency Image for Your Company

Christopher Marshallsay
Head of Medical Writing & Public Disclosure
Grünenthal

10:15

Networking and Refreshment Break

10:45

Chairman’s Day Two Remarks

Neil Garrett
Global Head, Regulatory Medical Writing
Janssen

Propelling Clinical Trial Transparency and
Publications into the Next Generation

11:00

Exchange Practical Strategies for Plain Language Summary Development and Implementation

Pooja Phoget
Vice President, Head of Development Operations
Kinapse, a Syneos Health Company

Vidhi Vashisht
Associate Director, Development Operations
Kinapse, a Syneos Health Company

11:45

Seeking the Power of Collaboration — Align Timelines between Publications and Clinical Data Disclosure Teams for Streamlined Success

Ada Staal
Clinical Trial Disclosure Specialist
Xogene Services

12:30

Networking Luncheon

13:45

PATIENT PERSPECTIVE Patients as Collaborators — The DNA of the Clinical Trial Lifecycle

Participants discuss how to involve patients so that they are collaborators throughout the clinical trial process from study design through results sharing. Learn how to define the value patient insight can provide for trials.

Helen Bulbeck
Director
brainstrust –the brain cancer people

14:45

CONCLUDING DISCUSSION Explore the Tomorrow of Data Transparency — What Is Next?

Neil Garrett
Global Head, Regulatory Medical Writing
Janssen

15:15

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE Tuesday, 11 June 2019

8:00

Conference Check-In and Welcome Refreshments

9:00

Chairman’s Opening Remarks

Neil Garrett
Global Head, Regulatory Medical Writing
Janssen

Review Regulatory Shifts and
Anticipated Changes for
Clinical Trial Data Requirements

9:15

Navigate HRA Requirements for Clinical Trial Transparency

Amanda Hunn
Principal, A J Hunn Associates;
former Head of Policy, Health Research Authority

10:05

Explore Recent Trends and Innovations in Data Sharing and Transparency

Thomas Wicks
Chief Strategy Officer
TrialScope

10:55

Networking and Refreshment Break

11:25

Dissect the Impact of the FDA Monetary Penalty Rule

Jo Anne Marie Blyskal
Head of Medical Writing & Clinical Trial Disclosure
Teva

12:15

Networking Luncheon

13:30

Writing for Our Audiences —
Develop Lean CSRs to Facilitate Regulatory Review and Limit Redactions

Joan Affleck
Executive Director, Head of Medical Writing
Merck

From the Theoretical to the Practical —
Deconstruct Roadblocks to
Results Posting and Data Anonymisation

14:15

PANEL DISCUSSION Share Challenges and Lessons Learned in Global Clinical Trial Data Disclosure

MODERATOR:

Jo Anne Marie Blyskal
Head of Medical Writing & Clinical Trial Disclosure
Teva

PANELISTS:

Kelly DiGian
Director, Data Transparency & Disclosure
Teva

Sybille Eibert
Associate Director, Transparency & Disclosure
Teva

Neil Garrett
Global Head, Regulatory Medical Writing
Janssen

15:15

Networking and Refreshment Break

15:45

INTERACTIVE WORKSHOP
Move Beyond the Quantification of Data Anonymisation

Participants gain a high-level understanding of the quantitative principles of data anonymisation and how to apply those to creating a report for both data sets and documents.

I. Learn the Basics of the Quantitative Approach

II. Review Technical Anonymisation Group (TAG) Initiatives and Progress

III. Quantify the Risk

IV. Develop Cohesive Data Anonymisation Reports

Workshop Leader:

Lukasz Kniola
Principal Analyst, Data Sharing
Biogen

17:15

Close of Day One

Please Join Us! Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Wednesday, 12 June 2019

8:00

Morning Refreshments

8:45

CHOOSE BETWEEN TWO BREAKOUTS (I-II)

BREAKOUT I CLINICAL DATA TRANSPARENCY Breaking Through Barriers
to Achieve Excellent
Disclosure Practices

Navigate Current and Future Requirements Related to Patient Level Data Sharing (PLDS)

Sophie Buyle
Project Manager, Web Disclosure
GSK

 
BREAKOUT II PUBLICATIONS Connecting New Developments
in Medical Publications with Strategies for Success

 

Innovations in Publications — Decipher Trends on Pre-Prints, Digital Publications, Open Access Policies and Plain Language Summaries

Susan Wieting
Director, Scientific Publications
Shire International GmbH,
now part of Takeda, Zug, Switzerland

9:30

CASE STUDY Build a Positive Public Data Transparency Image for Your Company

Christopher Marshallsay
Head of Medical Writing & Public Disclosure
Grünenthal

10:15

Networking and Refreshment Break

10:45

Chairman’s Day Two Remarks

Neil Garrett
Global Head, Regulatory Medical Writing
Janssen

Propelling Clinical Trial Transparency and
Publications into the Next Generation

11:00

Exchange Practical Strategies for Plain Language Summary Development and Implementation

Pooja Phoget
Vice President, Head of Development Operations
Kinapse, a Syneos Health Company

Vidhi Vashisht
Associate Director, Development Operations
Kinapse, a Syneos Health Company

11:45

Seeking the Power of Collaboration — Align Timelines between Publications and Clinical Data Disclosure Teams for Streamlined Success

Ada Staal
Clinical Trial Disclosure Specialist
Xogene Services

12:30

Networking Luncheon

13:45

PATIENT PERSPECTIVE Patients as Collaborators — The DNA of the Clinical Trial Lifecycle

Participants discuss how to involve patients so that they are collaborators throughout the clinical trial process from study design through results sharing. Learn how to define the value patient insight can provide for trials.

Helen Bulbeck
Director
brainstrust –the brain cancer people

14:45

CONCLUDING DISCUSSION Explore the Tomorrow of Data Transparency — What Is Next?

Neil Garrett
Global Head, Regulatory Medical Writing
Janssen

15:15

Close of Conference