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Agenda

Data Anonymisation | Policy 0070 | U.S. Final Rule | GDPR | Lay Summary Preparation | Publication Strategy

June 20-21, 2018
  • Amsterdam, The Netherlands

Agenda

Want more agenda details? Download the brochure.

DAY ONE Wednesday 20 June 2018

8:15

Conference Check-in and Continental Breakfast

9:15

Conference Chairman’s Welcome and Opening Remarks

Francis P. Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA)

Regulatory Snapshots — Taking the Pulse of Global Regulatory Requirements in Clinical Trial Transparency

9:30

Navigate EMA’s Further Guidance on Policy 0070 and Portal Preparations

Karen Quigley
Clinical Data Publication Manager
European Medicines Agency (EMA) 

10:15

Develop Your Disclosure Dashboard — A Quick Guide to Global Transparency

Thomas Wicks
Chief Strategy Officer
TrialScope

11:00

Networking and Refreshment Break

11:30

Understand the Impact of the EU General Data Protection Regulation (GDPR) on Transparency of Clinical Trial Data and Publications

Francis P. Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA)

12:15

Evaluate Trends in Industry Compliance with the U.S. Final Rule

Jenny Peterson
Director
Xogene Services

13:00

Networking Luncheon

14:15

CHOOSE BETWEEN TWO CONCURRENT WORKSHOPS (A-B)

WORKSHOP A From the Medical Writer to
the Publication — Gain Essential Tools for Writing a Peer-Reviewed Manuscript

I. Assess Industry Standards

II. Navigate Authorship Criteria

III. Cross-Functional Team Excellence

IV. Roundtable Discussion of Best Practices

Workshop Leaders:

Susan Wieting
Director, Publications
Shire

Cheryl McCoy, CMPP, PhD
Senior Director,
Medical Writing and Communications
Janssen

 
WORKSHOP B Policy 0070 Impact Assessment — Understand Quantified Risk Assessments, Create Data Anonymisation Strategies and Manage
the EMA Timeline

I. Policy 0070 Submission Preparation and Lessons Learned

II. Data Anonymisation and Redaction Processes

III. Interactive Risk Simulation

Workshop Leader:

Cathal Gallagher
Senior Life Sciences Consultant, D-Wise;
Member, PhUSE Data Transparency Working Group

There will be a 30-minute break at 15:30pm

17:15

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Thursday 21 June 2018

8:00

Continental Breakfast

8:30

Conference Chairman’s Review of Day One

Francis P. Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA)

Organise Strategies and Execution Plans for
Lay Summary Writing and Posting

8:45

Collaborate to Achieve Industry Harmonisation for Clinical Data Publication Posting

Kelley Kendle
President
Synchrogenix

9:30

Piloting Lay Summaries —
Development and Implementation of Best Practices and Processes

Thomas M. Schindler, Ph.D.
Head of Medical Writing Europe
Boehringer Ingelheim Pharma GmbH

10:15

Networking and Refreshment Break

10:45

Address Challenges in the Translation of Lay Summaries

Pooja Phogat
Vice President, Head of Development Operations
Kinapse, Inc.

11:30

Optimise Editorial Efficiency through Innovative Structured Authoring Practices

Jack Yeager
Chief Executive Officer
Sylogent

12:15

Networking Luncheon

13:30

CHOOSE BETWEEN TWO CONCURRENT TRACKS (I-II)

I. Publications

13:30

Should Scientific Publications Be Used as Way to Fulfill Transparency Obligations?

Barbara Pelgrims, Ph.D.
Strategic Publication Lead Neurology
UCB

14:15

Establish Strategic Timelines for Publication Development

Cheryl McCoy, CMPP, PhD
Senior Director, Medical Writing and Communications
Janssen

 
II. Clinical Trial Transparency

13:30

CASE STUDY Lessons Learned from Preparing Two Dossiers for Policy 0070 Submission and Publication

Sybille Eibert
Senior Manager, Global Regulatory Medical Writing, Transparency & Disclosure
Teva Pharmaceuticals International GmbH

14:15

Resolving Critical Disclosure Issues Think Tank

Julie Bryan
Posting and Disclosures Manager
F. Hoffmann La Roche Ltd.

15:00

Networking and Refreshment Break

15:15

CLOSING SESSION Compare and Contrast Qualitative and Quantitative Data Anonymisation Methods

I. BIOGEN CASE STUDY Assess the Metrics and Methodology to Calculate the Risk of
Re-Identification of Patient Data — A Quantitative Approach

Lukasz Kniola
Principal Analyst, Data Sharing
Biogen

II. BOEHRINGER INGELHEIM CASE STUDY Share the Strategy and Lessons Learned from a Qualitative Approach to Data Anonymisation

Alexandra Marquart
Teamleader Clinical Data Transparency
Boehringer Ingelheim Pharma GmbH

III. Interactive Activity — Compare the Feasibility and Success of Each Method

Lukasz Kniola
Principal Analyst, Data Sharing
Biogen

Alexandra Marquart
Teamleader Clinical Data Transparency
Boehringer Ingelheim Pharma GmbH

16:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Wednesday 20 June 2018

8:15

Conference Check-in and Continental Breakfast

9:15

Conference Chairman’s Welcome and Opening Remarks

Francis P. Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA)

Regulatory Snapshots — Taking the Pulse of Global Regulatory Requirements in Clinical Trial Transparency

9:30

Navigate EMA’s Further Guidance on Policy 0070 and Portal Preparations

Karen Quigley
Clinical Data Publication Manager
European Medicines Agency (EMA) 

10:15

Develop Your Disclosure Dashboard — A Quick Guide to Global Transparency

Thomas Wicks
Chief Strategy Officer
TrialScope

11:00

Networking and Refreshment Break

11:30

Understand the Impact of the EU General Data Protection Regulation (GDPR) on Transparency of Clinical Trial Data and Publications

Francis P. Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA)

12:15

Evaluate Trends in Industry Compliance with the U.S. Final Rule

Jenny Peterson
Director
Xogene Services

13:00

Networking Luncheon

14:15

CHOOSE BETWEEN TWO CONCURRENT WORKSHOPS (A-B)

WORKSHOP A From the Medical Writer to
the Publication — Gain Essential Tools for Writing a Peer-Reviewed Manuscript

I. Assess Industry Standards

II. Navigate Authorship Criteria

III. Cross-Functional Team Excellence

IV. Roundtable Discussion of Best Practices

Workshop Leaders:

Susan Wieting
Director, Publications
Shire

Cheryl McCoy, CMPP, PhD
Senior Director,
Medical Writing and Communications
Janssen

 
WORKSHOP B Policy 0070 Impact Assessment — Understand Quantified Risk Assessments, Create Data Anonymisation Strategies and Manage
the EMA Timeline

I. Policy 0070 Submission Preparation and Lessons Learned

II. Data Anonymisation and Redaction Processes

III. Interactive Risk Simulation

Workshop Leader:

Cathal Gallagher
Senior Life Sciences Consultant, D-Wise;
Member, PhUSE Data Transparency Working Group

There will be a 30-minute break at 15:30pm

17:15

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Thursday 21 June 2018

8:00

Continental Breakfast

8:30

Conference Chairman’s Review of Day One

Francis P. Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA)

Organise Strategies and Execution Plans for
Lay Summary Writing and Posting

8:45

Collaborate to Achieve Industry Harmonisation for Clinical Data Publication Posting

Kelley Kendle
President
Synchrogenix

9:30

Piloting Lay Summaries —
Development and Implementation of Best Practices and Processes

Thomas M. Schindler, Ph.D.
Head of Medical Writing Europe
Boehringer Ingelheim Pharma GmbH

10:15

Networking and Refreshment Break

10:45

Address Challenges in the Translation of Lay Summaries

Pooja Phogat
Vice President, Head of Development Operations
Kinapse, Inc.

11:30

Optimise Editorial Efficiency through Innovative Structured Authoring Practices

Jack Yeager
Chief Executive Officer
Sylogent

12:15

Networking Luncheon

13:30

CHOOSE BETWEEN TWO CONCURRENT TRACKS (I-II)

I. Publications

13:30

Should Scientific Publications Be Used as Way to Fulfill Transparency Obligations?

Barbara Pelgrims, Ph.D.
Strategic Publication Lead Neurology
UCB

14:15

Establish Strategic Timelines for Publication Development

Cheryl McCoy, CMPP, PhD
Senior Director, Medical Writing and Communications
Janssen

 
II. Clinical Trial Transparency

13:30

CASE STUDY Lessons Learned from Preparing Two Dossiers for Policy 0070 Submission and Publication

Sybille Eibert
Senior Manager, Global Regulatory Medical Writing, Transparency & Disclosure
Teva Pharmaceuticals International GmbH

14:15

Resolving Critical Disclosure Issues Think Tank

Julie Bryan
Posting and Disclosures Manager
F. Hoffmann La Roche Ltd.

15:00

Networking and Refreshment Break

15:15

CLOSING SESSION Compare and Contrast Qualitative and Quantitative Data Anonymisation Methods

I. BIOGEN CASE STUDY Assess the Metrics and Methodology to Calculate the Risk of
Re-Identification of Patient Data — A Quantitative Approach

Lukasz Kniola
Principal Analyst, Data Sharing
Biogen

II. BOEHRINGER INGELHEIM CASE STUDY Share the Strategy and Lessons Learned from a Qualitative Approach to Data Anonymisation

Alexandra Marquart
Teamleader Clinical Data Transparency
Boehringer Ingelheim Pharma GmbH

III. Interactive Activity — Compare the Feasibility and Success of Each Method

Lukasz Kniola
Principal Analyst, Data Sharing
Biogen

Alexandra Marquart
Teamleader Clinical Data Transparency
Boehringer Ingelheim Pharma GmbH

16:30

Close of Conference