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This compendium consists of materials submitted by the speakers that complement their presentations. We understand what an important resource this material is and we have made a concerted effort to secure biographical sketches, outlines and related materials.

Additionally, you will find included helpful information on solution providers, publications and associations, including links to their websites.

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Presentations

 

WORKSHOP B Capitalize on Enhanced Reporting Strategies for Global IISR Programs

I. Implement Negotiating Best Practices for Global Contracts

II. Uncover the Complexities of Multi-Party Contracts

III. Define Contract Language for Interactions with Investigators

Workshop Leaders:

Terry Burton
Manager, Clinical Contracts and Finance
Gilead Sciences

Dianne Archer
Corporate Counsel
Gilead Sciences

Optimize the IISR Process from Protocol Submission through Study Completion

Audra Krammerer, Ph.D.
Senior Manager, MSL Team
Theravance BioPharma Inc.

Lynne Gordon
Associate Director, Medical Affairs
Theravance BioPharma Inc.

Collaborative Studies vs. IISR — Determining When to Implement Each Approach

Debbie Kerr-Leathem, PMP, COP
IIS Global Lead-GCDO-MAO, Clinical Program Leader
IIS Medical Affairs – North America Region
Johnson & Johnson

Gain Scientific Value from IISR Programs in the Developing Countries

Arturo Benitez
Associate Medical Director Neurosciences Latin America
UCB

Benchmark Best Practices for Negotiating Contracts to Improve Study Start-Up

Surabhi Sharma
Associate Director, Clinical Research
Novartis Consumer Health

Develop Clear Governance Guidelines to Ensure Program Execution

Jean Sowa
Operations Lead External Scientific Research
AstraZeneca

Define Best Practices for Publication Management in IISR
Sustain Compliance with an Efficient Mitigation Strategy
Best Practices for Financial Transparency Reporting

Carlota Johnsen
Director, Global Medical Evidence Delivery
AstraZeneca

Analyze ACRP’s Industry Benchmarking Survey Results —
IISR Trends and Best Practices

Ashley Wills
Senior Manager Medical Affairs Research
TESARO

Scott Cunningham
Business Lead
Envision Pharma

Establish Thorough Safety Management with Efficient Reporting Practices

Lillian Kirk
Associate Director, Drug Safety Surveillance Pharmacovigilance
Progenics Pharmaceuticals Inc.

Speaker Bios

Dianne Archer
Corporate Counsel
Gilead Sciences

Karen L. Bartels, RN, OCN, MBA, PMP©
Business Area Lead, External Scientific Research Operations
AstraZeneca

Arturo Benitez
Associate Medical Director Neurosciences Latin America
UCB

Terry Burton
Manager, Clinical Contracts and Finance
Gilead Sciences

Scott Cunningham
Business Lead
Envision Pharma

Lynne Gordon
Associate Director, Medical Affairs
Theravance BioPharma Inc.

Carlota Johnsen
Director, Global Medical Evidence Delivery
AstraZeneca

Debbie Kerr-Leathem, PMP, COP
IIS Global Lead-GCDO-MAO, Clinical Program Leader
IIS Medical Affairs – North America Region
Johnson & Johnson

Lillian Kirk
Associate Director, Drug Safety Surveillance Pharmacovigilance
Progenics Pharmaceuticals Inc.

Samantha Koth
Senior Manager, Medical Education and
Investigator Initiated Study Grants
Sunovion Pharmaceuticals Inc.

Meg Mooney
Chief Clinical Investigations Branch
National Cancer Institute

Erin Mueller
Alliance Manager of Agreements and Development
Alliance for Clinical Trials in Oncology

Surabhi Sharma
Associate Director, Clinical Research
Novartis Consumer Health

Jean Sowa
Operations Lead External Scientific Research
AstraZeneca

Sharon Harston Stine
Executive Director Philadelphia West
NRG Oncology

Alison Urton
Group Administrator
NCIC-CTG

Ashley Wills
Senior Manager Medical Affairs Research
TESARO

  Agenda
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Envision Pharma Group

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