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Agenda

Endpoint Adjudication • Safety Assessment • Data Monitoring

November 6-7, 2018
  • Amsterdam, The Netherlands

Agenda

Want more agenda details? Download the brochure.

DAY ONE | Tuesday, 6 November 2018

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S (Denmark)

8:45

REGULATORY DEEP DIVE Regulatory Trends in Adjudication and Endpoints in the FDA and EMA

Dimitri Stamatiadis, PhD, MBA
Founder and Chief Executive Officer
MAIA Consulting

9:30

Breaking Down Silos — Align and Collaborate Across Independent Expert Committees to Improve Efficiency

Aisha Rashid
SMA Programme Lead
Biogen

10:15

Establish Best Practices for Committee Selection and Charter Development

Jonathan Seltzer, MD, MBA, MA, FACC
President
ACI Clinical

11:00

Networking and Refreshment Break

11:30

T-Minus 6 Weeks — Complete Specification Documents to Get an Adjudication System Properly Programmed in Six Weeks or Less

Kimberly Brown, RN
C5R CEC Manager, Research Programmes
Cleveland Clinic

12:15

Networking Luncheon

13:15

ROUNDTABLE DISCUSSION Support Clinical Trials and Collection of Endpoint Data with CRA’s in Mind

MODERATOR:

Catherine Tyner
Executive Director, Drug Safety and Adjudication Services
Covance

14:00

Choose Between Two In-Conference Workshops (A-B)

WORKSHOP A

14:00

Endpoint Adjudication Therapeutic- Area Case Study Symposium

14:00

Workshop Chair Opening Remarks

14:10

Cancer Adjudication, Fracture Adjudication, CV Events and Stroke in a Single Trial

Kimberly Brown, RN
C5R CEC Manager, Research Programmes
Cleveland Clinic

14:50

Oncology Adjudicator Feedback and Q&A

15:05

Rare Disease Adjudication Considerations

Gerard Barron
Director, Clinical Operations
MedImmune (Philadelphia)

15:45

Rare Disease Adjudicator Feedback and Q&A

16:00

Networking and Refreshment Break

16:30

Cardiovascular Device Endpoint Adjudication

Sylvie Bartus, PhD
Director, Safety Officer, Global
Clinical Affairs, Heart Valve Therapy
Edwards Lifesciences

17:10

Cardiovascular Adjudicator Feedback and Q&A

17:25

Workshop Leaders Closing Remarks

17:30

Close of Workshop A

MODERATOR:

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S (Denmark)

 
WORKSHOP B

14:00

Data Monitoring and Safety Monitoring Committee Intensive Masterclass – Standardisation, Communication and Committee Alignment

As Data Monitoring and Safety Monitoring Committees continue to grow in prevalence, several issues have arisen. While these Committees monitor trial conduct and safety, making recommendations for trial changes or closure, a lack of consistency currently exists across Committees. Stakeholders are faced with unclear expectations, communication challenges and a lack of direction. This workshop deep dives into best practices and solutions to properly train committees, ensure data privacy in light of GDPR and evolving regulatory guidance and develop clear and consistent charters.

I. Data Monitoring and Safety Monitoring Committees Formation and Development

II. Regulatory Update on Data Monitoring and Safety Monitoring Committees

III. Improve Communication between Committee Members and Trial Stakeholders

16:00

Networking and Refreshment Break

17:25

Workshop Leaders Closing Remarks

17:30

Close of Workshop B

MODERATOR:

Catherine Tyner
Executive Director, Drug Safety and Adjudication Services
Covance

DAY TWO | Wednesday, 7 November, 2018

8:30

Chairman’s Review of Day One

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S (Denmark)

8:45

Critical Insights into Process Bottlenecks and Expert Committee Challenges — Endpoint Definitions, Adverse Events and Packet Submission

Michal Konstacky, MD, PhD, MBA
Global Medical Director
Shire

9:30

Contemporary Endpoints Definitions in Cardiovascular Trials —
Critical Appraisal and Practical Recommendations

Ernest Spitzer, MD
Director of Clinical Endpoint Adjudication
Cardialysis

10:15

Networking and Refreshment Break | Hosted by:

10:45

ROUNDTABLE DISCUSSION Plan, Recruit For and Manage Data Monitoring Committees

MODERATOR:

Dimitri Stamatiadis, PhD, MBA
Founder and Chief Executive Officer
MAIA Consulting

11:45

Adjudication – The Data Trust & Security Angle

Beat Widler
Head of Quality Assurance, Managing Partner
Ethical GMBH

12:30

Networking Luncheon

13:30

CBI’s Endpoint Adjudication Working Group

WORKING GROUP MODERATOR:

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S (Denmark)

14:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE | Tuesday, 6 November 2018

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S (Denmark)

8:45

REGULATORY DEEP DIVE Regulatory Trends in Adjudication and Endpoints in the FDA and EMA

Dimitri Stamatiadis, PhD, MBA
Founder and Chief Executive Officer
MAIA Consulting

9:30

Breaking Down Silos — Align and Collaborate Across Independent Expert Committees to Improve Efficiency

Aisha Rashid
SMA Programme Lead
Biogen

10:15

Establish Best Practices for Committee Selection and Charter Development

Jonathan Seltzer, MD, MBA, MA, FACC
President
ACI Clinical

11:00

Networking and Refreshment Break

11:30

T-Minus 6 Weeks — Complete Specification Documents to Get an Adjudication System Properly Programmed in Six Weeks or Less

Kimberly Brown, RN
C5R CEC Manager, Research Programmes
Cleveland Clinic

12:15

Networking Luncheon

13:15

ROUNDTABLE DISCUSSION Support Clinical Trials and Collection of Endpoint Data with CRA’s in Mind

MODERATOR:

Catherine Tyner
Executive Director, Drug Safety and Adjudication Services
Covance

14:00

Choose Between Two In-Conference Workshops (A-B)

WORKSHOP A

14:00

Endpoint Adjudication Therapeutic- Area Case Study Symposium

14:00

Workshop Chair Opening Remarks

14:10

Cancer Adjudication, Fracture Adjudication, CV Events and Stroke in a Single Trial

Kimberly Brown, RN
C5R CEC Manager, Research Programmes
Cleveland Clinic

14:50

Oncology Adjudicator Feedback and Q&A

15:05

Rare Disease Adjudication Considerations

Gerard Barron
Director, Clinical Operations
MedImmune (Philadelphia)

15:45

Rare Disease Adjudicator Feedback and Q&A

16:00

Networking and Refreshment Break

16:30

Cardiovascular Device Endpoint Adjudication

Sylvie Bartus, PhD
Director, Safety Officer, Global
Clinical Affairs, Heart Valve Therapy
Edwards Lifesciences

17:10

Cardiovascular Adjudicator Feedback and Q&A

17:25

Workshop Leaders Closing Remarks

17:30

Close of Workshop A

MODERATOR:

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S (Denmark)

 
WORKSHOP B

14:00

Data Monitoring and Safety Monitoring Committee Intensive Masterclass – Standardisation, Communication and Committee Alignment

As Data Monitoring and Safety Monitoring Committees continue to grow in prevalence, several issues have arisen. While these Committees monitor trial conduct and safety, making recommendations for trial changes or closure, a lack of consistency currently exists across Committees. Stakeholders are faced with unclear expectations, communication challenges and a lack of direction. This workshop deep dives into best practices and solutions to properly train committees, ensure data privacy in light of GDPR and evolving regulatory guidance and develop clear and consistent charters.

I. Data Monitoring and Safety Monitoring Committees Formation and Development

II. Regulatory Update on Data Monitoring and Safety Monitoring Committees

III. Improve Communication between Committee Members and Trial Stakeholders

16:00

Networking and Refreshment Break

17:25

Workshop Leaders Closing Remarks

17:30

Close of Workshop B

MODERATOR:

Catherine Tyner
Executive Director, Drug Safety and Adjudication Services
Covance

DAY TWO | Wednesday, 7 November, 2018

8:30

Chairman’s Review of Day One

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S (Denmark)

8:45

Critical Insights into Process Bottlenecks and Expert Committee Challenges — Endpoint Definitions, Adverse Events and Packet Submission

Michal Konstacky, MD, PhD, MBA
Global Medical Director
Shire

9:30

Contemporary Endpoints Definitions in Cardiovascular Trials —
Critical Appraisal and Practical Recommendations

Ernest Spitzer, MD
Director of Clinical Endpoint Adjudication
Cardialysis

10:15

Networking and Refreshment Break | Hosted by:

10:45

ROUNDTABLE DISCUSSION Plan, Recruit For and Manage Data Monitoring Committees

MODERATOR:

Dimitri Stamatiadis, PhD, MBA
Founder and Chief Executive Officer
MAIA Consulting

11:45

Adjudication – The Data Trust & Security Angle

Beat Widler
Head of Quality Assurance, Managing Partner
Ethical GMBH

12:30

Networking Luncheon

13:30

CBI’s Endpoint Adjudication Working Group

WORKING GROUP MODERATOR:

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S (Denmark)

14:30

Close of Conference