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09: Regulatory [clear filter]
Tuesday, June 25
 

11:45am

#250 CH: How to Efficiently Implement a Healthcare Compliance Program in Preparation for Your First Product Launch
Component Type: Workshop
Level: Basic

This interactive workshop will address important government requirements impacting life sciences companies pre- and post-commercialization, as well as discuss approaches to implementing strong healthcare compliance programs with limited resources.

Learning Objectives

Discuss the importance of ethical conduct, and how compliance generates future success (before and after commercialization); Describe the relevant healthcare compliance-related laws, regulations and guidances; Identify methods to implement efficiently implement a healthcare compliance program despite limited resources.

Chair

Marc Adler, JD


Speakers
MA

Marc Adler

President, Global Compliance Strategies


Tuesday June 25, 2019 11:45am - 12:15pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#275 EE: Access to Investigational Drugs Outside of Clinical Trials: What's Fair?
Component Type: Workshop
Level: Basic

Requests for investigational drugs are increasing, posing ethical, regulatory, and logistical challenges for companies. After discussing a fictional case, participants will understand these challenges and be better prepared to address them.

Learning Objectives

Discuss ethical, legal, and practical concerns surrounding patient requests for access to investigational drugs outside of clinical trials (preapproval access); Apply this knowledge to a fictitious case study; Analyze the pros and cons of different possible responses in real world scenarios.

Chair

Alison Bateman-House, PhD, MA, MPH

Speaker

Facilitator
Beverly L Harrison



Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, NYU Langone Health
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning... Read More →
avatar for Beverly Harrison

Beverly Harrison

Head, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson
Leading the Patient Support Group @ Janssen R&D (a J&J Co.), reporting directly to the Chief Medical Officer, Beverly focuses on developing strategies for patients’ needs by working with internal/external stakeholders & engaging patient advocacy organizations. She is a R&D & nonprofit... Read More →


Tuesday June 25, 2019 3:15pm - 4:15pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

12:30pm

#349 EE: Regulatory Affairs Governance: Benchmarking and Sharing of Best Practices
Component Type: Workshop
Level: Intermediate

Gain a deeper understanding of governance in regulatory affairs through this discussion-based workshop where you’ll be teamed with peers to share your experiences and assess your company’s procedures to encourage efficient decision-making processes.

Learning Objectives

Describe how to benchmark internal governance within Regulatory Affairs in other pharmaceutical companies by engaging in peer discussion -Identify the importance and benefits of a well-functioning governance model; Explain how to utilize learnings to identify potential areas of improvement within your own company.

Chair

Benjamin Sugden, PharmD


Speakers
avatar for Benjamin Sugden

Benjamin Sugden

Assistant Director Regulatory Affairs, North America Regional Operations, Bayer U.S. Pharmaceuticals
Benjamin Sugden, Pharm.D., is currently the Assistant Director of Regulatory Affairs, North America Regional Operations for Bayer U.S. Pharmaceuticals. Dr. Sugden has previously served within Regulatory Affairs as a Senior Information Scientist. Before joining Bayer in 2017, he gained... Read More →


Wednesday June 26, 2019 12:30pm - 1:30pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:15pm

#353 CH: The Current and Future State of RIM
Component Type: Workshop
Level: Basic

An open discussion about the current and future state of RIM within different sized organizations with emphasis on the pros/cons of having a cloud based solution, the benefit of crafting a RIM ecosystem and approaching change management.

Learning Objectives

Describe the current and future state of RIM; Discuss the value added of crafting a complete RIM eco system; Identify and anticipate the impact of these systems on the end users.

Chair

Richard F Fredericks


Speakers
avatar for Richard Fredericks

Richard Fredericks

Director, Regulatory Systems and Information Management, Tesaro
I have been in the life sciences industry for 10+ years operating entirely within the Regulatory Operations space. My career began as a publisher and over the past decade has been gravitating towards the technology and process side of the business. Currently I lead the Regulatory... Read More →


Wednesday June 26, 2019 1:15pm - 1:45pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA