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Agenda

Navigate Medical Affairs Complexities and Shine Light on R&D Compliance to Propel Scientific Exchange

December 4-5, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, DECEMBER 4, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Ann Ford
Chief Ethics and Compliance Officer, Deputy General Counsel
Medline Industries

Emerging Enforcement Trends and
Focal Points for 2019

8:45

Examine the Latest Trends in Off-Label Enforcement and Uncover Emerging
High-Risk Areas Needing Heightened Oversight

Charles Graybow
Assistant United States Attorney
U.S. Attorney’s Office for the District of New Jersey

Dan Sale
Attorney
King & Spaulding

9:30

Industry Playbook Identify Barriers to Off-Label Communication to Ensure Alignment with
FDA Regulations

Donna White
Vice President, Contracts and Compliance
Chiesi USA, Inc.

10:15

Networking and Refreshment Break

Balancing Promotion Versus Scientific Exchange to Optimize Compliance

10:45

Partnership Pavilion Gaining Clarity —
Working CrossFunctionally to Ensure Compliance Enterprise-Wide

Kyle Fletcher
Corporate Attorney and Compliance Officer
Celularity, Inc.

Maureen Nagelberg
Senior Compliance Manager
Otsuka Pharmaceutical Companies

Gregory Moss
Senior Vice President, Deputy General Counsel
Kadmon Corporation

11:30

Dive into the Legal Implications of Nurse Educator Programs

Ann Ford
Chief Ethics and Compliance Officer, Deputy General Counsel
Medline Industries

Jennifer Romanski
Counsel
Porzio Life Sciences

12:15

Networking Luncheon

1:30

Establish Compliant Internal Protocols —
Best Practices for Auditing and Monitoring Your Non-Promotional Activities

Speaker TBA

2:15

Identify Strategies to Ensure Compliant and Effective HCP Interactions

Howard Dorfman
Founder
H.L Dorfman Pharmaceutical Consulting, LLC

3:00

Networking and Refreshment Break

3:30

Implementing and Overseeing Medical Science Liaison Programs

Alyson Evans
Medical Science Liaison
Alimera Sciences

4:15

Making the Most Out of Your Advisory Board —
Strategies to Ensuring Compliant Collaboration

Speaker TBA

5:00

Close of Day One

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

DAY TWO WEDNESDAY, DECEMBER 5, 2018

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

Ann Ford
Chief Ethics and Compliance Officer, Deputy General Counsel
Medline Industries

Navigate Compliance Risks Associated with Patient Assistance and Support Programs

8:15

Demonstrate Compliance Considerations and Best Practices within Patient Assistance and Support Programs

Sheea Sybblis, JD, MBA
Senior Counsel
Boehringer Ingelheim Pharmaceuticals

9:00

Promotion Versus Scientific Exchange — Identify Boundaries Related to Medical Information and Communication Interaction

Marc Clausseen
Sr. Director, Market Access
Chiesi USA, Inc.

9:45

Networking and Refreshment Break

Clinical and R&D Oversight to
Maintain Compliance

10:15

Top Compliance Risks Throughout the Clinical Trial Lifecycle

Erin Teetshorn
Senior Counsel, Research and Development
Takeda

11:00

Engage in Compliant Pre-Approval Communication

Speaker TBA

11:45

Networking Luncheon

12:45

Best Practices for Utilizing Investigator Initiated Sponsored Research (IISR) In Line with Organizational Goals

Alyssa Truong
Senior Manager, Medical Affairs
Jazz Pharmaceuticals, Inc.

1:30

Choose From 3 Tailored Working Groups (A-C)

A Optimize Compliance Programs for Non-Promotional Activities for Small to Mid-Sized Companies

B Adjust Non-Promotional Goals to Meet Compliance Standards within Large Global Organizations

C Introduce Non-Promotional Compliance Considerations into Medical Device Product Lifecycles

FACILITATOR:

Maureen Nagelberg
Senior Compliance Manager
Otsuka Pharmaceutical Companies

2:30

Chairman’s Closing Remarks

Ann Ford
Chief Ethics and Compliance Officer, Deputy General Counsel
Medline Industries

2:45

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, DECEMBER 4, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Ann Ford
Chief Ethics and Compliance Officer, Deputy General Counsel
Medline Industries

Emerging Enforcement Trends and
Focal Points for 2019

8:45

Examine the Latest Trends in Off-Label Enforcement and Uncover Emerging
High-Risk Areas Needing Heightened Oversight

Charles Graybow
Assistant United States Attorney
U.S. Attorney’s Office for the District of New Jersey

Dan Sale
Attorney
King & Spaulding

9:30

Industry Playbook Identify Barriers to Off-Label Communication to Ensure Alignment with
FDA Regulations

Donna White
Vice President, Contracts and Compliance
Chiesi USA, Inc.

10:15

Networking and Refreshment Break

Balancing Promotion Versus Scientific Exchange to Optimize Compliance

10:45

Partnership Pavilion Gaining Clarity —
Working CrossFunctionally to Ensure Compliance Enterprise-Wide

Kyle Fletcher
Corporate Attorney and Compliance Officer
Celularity, Inc.

Maureen Nagelberg
Senior Compliance Manager
Otsuka Pharmaceutical Companies

Gregory Moss
Senior Vice President, Deputy General Counsel
Kadmon Corporation

11:30

Dive into the Legal Implications of Nurse Educator Programs

Ann Ford
Chief Ethics and Compliance Officer, Deputy General Counsel
Medline Industries

Jennifer Romanski
Counsel
Porzio Life Sciences

12:15

Networking Luncheon

1:30

Establish Compliant Internal Protocols —
Best Practices for Auditing and Monitoring Your Non-Promotional Activities

Speaker TBA

2:15

Identify Strategies to Ensure Compliant and Effective HCP Interactions

Howard Dorfman
Founder
H.L Dorfman Pharmaceutical Consulting, LLC

3:00

Networking and Refreshment Break

3:30

Implementing and Overseeing Medical Science Liaison Programs

Alyson Evans
Medical Science Liaison
Alimera Sciences

4:15

Making the Most Out of Your Advisory Board —
Strategies to Ensuring Compliant Collaboration

Speaker TBA

5:00

Close of Day One

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

DAY TWO WEDNESDAY, DECEMBER 5, 2018

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

Ann Ford
Chief Ethics and Compliance Officer, Deputy General Counsel
Medline Industries

Navigate Compliance Risks Associated with Patient Assistance and Support Programs

8:15

Demonstrate Compliance Considerations and Best Practices within Patient Assistance and Support Programs

Sheea Sybblis, JD, MBA
Senior Counsel
Boehringer Ingelheim Pharmaceuticals

9:00

Promotion Versus Scientific Exchange — Identify Boundaries Related to Medical Information and Communication Interaction

Marc Clausseen
Sr. Director, Market Access
Chiesi USA, Inc.

9:45

Networking and Refreshment Break

Clinical and R&D Oversight to
Maintain Compliance

10:15

Top Compliance Risks Throughout the Clinical Trial Lifecycle

Erin Teetshorn
Senior Counsel, Research and Development
Takeda

11:00

Engage in Compliant Pre-Approval Communication

Speaker TBA

11:45

Networking Luncheon

12:45

Best Practices for Utilizing Investigator Initiated Sponsored Research (IISR) In Line with Organizational Goals

Alyssa Truong
Senior Manager, Medical Affairs
Jazz Pharmaceuticals, Inc.

1:30

Choose From 3 Tailored Working Groups (A-C)

A Optimize Compliance Programs for Non-Promotional Activities for Small to Mid-Sized Companies

B Adjust Non-Promotional Goals to Meet Compliance Standards within Large Global Organizations

C Introduce Non-Promotional Compliance Considerations into Medical Device Product Lifecycles

FACILITATOR:

Maureen Nagelberg
Senior Compliance Manager
Otsuka Pharmaceutical Companies

2:30

Chairman’s Closing Remarks

Ann Ford
Chief Ethics and Compliance Officer, Deputy General Counsel
Medline Industries

2:45

Close of Conference