4th Annual Life Science Ethics and Compliance Training Conference

June 5-6, 2019 | Chicago, IL

Doubletree by Hilton Chicago O’Hare Airport Rosemont

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DAY ONE | WEDNESDAY, JUNE 5TH

8:00 REGISTRATION & WELCOME COFFEE

8:45 CHAIRPERSON’S OPENING REMARKS
Dan O’Connor, Senior Vice President, NXLEVEL SOLUTIONS

9:00 ICE-BREAKER: MOTIVATING COMPLIANCE COMPANY WIDE
Compliance professionals ensure employees are properly educated on the latest regulations through direct communication and training sessions, but maintaining a high level of engagement and cognizance company-wide poses another challenge all together. Effectively motivating employees to act correctly outside of a conventional training session is an essential part of minimizing risk and building a corporate culture that values compliance. For this icebreaker session, participants will have a chance to connect with other professionals and discuss what tools, incentives or methods are best employed to emphasize the importance of compliance throughout day to day operations on a local, regional or global scale.

Dan O’Connor, Senior Vice President, NXLEVEL SOLUTIONS

 

9:15 KEYNOTE PANEL: ASSESSING RISK TOLERANCE & COMPANY CULTURE AS A DRIVER FOR ETHICS & COMPLIANCE EDUCATION
Prior to developing a training program and to incorporate a culture of compliance, executive leaders must communicate the risk tolerance of the organization to training teams in order for educational efforts to reflect the ethical actions of leadership. Understanding the risk tolerance is especially important for compliance officers as this factor is a primary influencer that drives the content and focus of compliance training efforts. A panel of executive leaders will discuss risk, how to shape training based on tolerance, and convey liabilities to ultimately create a culture of compliant and ethical behavior throughout the organization.

  • Risk tolerance for varying sized organizations
  • Communicating risk throughout the company
  • Understanding risk tolerance to shape curriculum

MODERATOR:
John Kelly, BASS, BERRY, & SIMS

PANELISTS:
Priya Mannan, NOVARTIS

Mike Kent, GILEAD

Gwen Chapman, TELEFLEX

 

MULTI PART MODULE: TRAINING EXCELLENCE IN EMERGING & EVOLVING COMPLIANCE RISK AREAS
Recent government investigations into patient assistance programs, speaker programs and allegations of off-label marketing being considered within Anti-Kickback and False Claims Act frameworks have dramatically increased the compliance risk for life science corporations. As a result, compliance training executives are undertaking deeper risk assessments into potential areas of risk, and aligning training content to reflect these emergent areas of potential non-compliance. Building a foundation through analysis of recent investigations and enforcement action, followed by case studies of proactive organizations effectively conveying and mitigating risks will ensure corporations are prepared to meet evolving regulatory and legal requirements.

 

10:00 LEGAL INTERPRETATION OF ENFORCEMENT TRENDS & AREAS OF INSPECTION

  • Assistance programs within Anti-Kickback statutes
  • Speaker bureaus & speaker influence programs
  • Off-label marketing & the False Claims Act

John Kelly, Member, BASS, BERRY, & SIMS

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 CASE STUDY: RISK EVALUATION & TRAINING APPROACHES FOR COMPLIANT PATIENT ASSISTANCE PROGRAMS

  • Scope of compliance risk within patient assistance programs:
    • Nurse education
    • Free Drug Programs
    • Coupons
    • Insurance Delay
    • Reimbursement support
  • Identifying stakeholders involved in Patient Assistance Programs
  • Effective training message & delivery on Anti-Kickback rules

Gretchen Cseplo, Compliance Officer, U.S., Canada & Director, Global Compliance Operations, CONVATEC

Catherine Starks, Associate, SIDLEY AUSTIN

 

11:45 CASE STUDY: IDENTIFYING & REDUCING COMPLIANCE RISK IN MARKETING AND SALES MATERIALS

  • Identifying the risks that affect marketing each product
  • Involved stakeholders in developing or using materials including:
    • Advertisement agencies
    • Sales & marketing leadership
    • Product managers
    • Sales representative
  • Effectively structuring training to reduce risks
  • Evaluating need for repeated training

Sharon Delshad, Director, Compliance & Legal Affairs, NALPROPION PHARMACEUTICALS

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

1:15 DEVELOPING A COMPLIANCE TRAINING CADENCE BASED ON RISK & NEEDS OF BUSINESS
Appropriate training cadence is selected through evaluating a number of aspects including risk of noncompliance, with high risk topics taking precedent, employee reminders for upcoming events, such as trade show guidance, and scheduling requests from internal associates for particular concerns. Trainers determine which subjects should be dispersed throughout the year, educated on a yearly basis, or receive longer intervals between courses. While managing the companywide curriculum along with individual function programs, compliance trainers must establish a cadence to coincide with business agendas and timetables to inform stakeholders at optimal moments.

  • Developing cadence through risk assessment
  • Accepting internal input to schedule courses
  • Aligning calendar with business needs & events

Priya Mannan, Executive Director, Global Head of Compliance,
Data Privacy, Associate General Counsel, NOVARTIS

 

1:45 TAILORING COMPLIANCE TRAINING BASED ON THE AUDIENCE & RELEVANCE TO JOB RESPONSIBILITIES
Compliance content is often tailored based on individual audience needs, including variations to accommodate different teams such as the sales force, technical roles, and executive leadership. Compliance courses are customized not only for the level of the employee, with directors and managers requiring separate material, but also for the risk of the overall job function depending on the daily interactions and responsibilities of each team. Trainers must collaborate with various business units to assess extent of compliance education and discover emerging areas of concern.

  • Reviewing risks associated with different job functions
  • Developing content relevant to unique team needs
  • Collaboration with units to assess training gaps

Virginia MacSuibhne, Vice President, Chief Compliance Officer, ROCHE MOLECULAR SOLUTIONS

 

DEEP-DIVE CASE STUDIES: MEASURING TRAINING EFFECTIVENESS & RISK REDUCTION
In order to maintain financial and resource support from executive leadership, compliance training executives must demonstrate a level of return on investment, which is of considerable difficulty in an area where traditional metrics such as commercial outcomes have little relevance. At the same time, compliance teams are integrating creative methods for tracking, auditing and measuring training courses, from monitoring course engagement and completion, to short and long-term retention of training material. Ultimately demonstrating a reduction in potential risks, the brief deep-dive case study format of the following presentations will highlight areas of training measured, tools used to track participation and strategies used to translate effectiveness into monetized return.

  • Strategy behind training metric development
  • Tools used to track retention & engagement
  • Translating data into actionable strategy

 

2:30 EXSURCO CASE STUDY
Swasita Saigal, Director, Regulatory Affairs and Corporate Compliance, EXSURCO

 

3:00 COFFEE & NETWORKING BREAK

 

3:30 GILEAD CASE STUDY
Mike Kent, Senior Manager, Compliance, Training & Development, GILEAD

 

4:00 BLENDING DELIVERY METHODS TO DEVELOP AN EFFECTIVE COMPLIANCE CIRRICULUM
With a wide variety of methods available, compliance trainers evaluate the best delivery vehicle for educational content and develop a unique system of blended learning to correspond with audience needs. Whereas some employees retain information through more traditional approaches such as live training or reading literature and newsletters, many stakeholders prefer watching videos, listening to podcasts, or interactive platforms, such as gamification. Recognizing the audience preferences and requirements as well as techniques to provide specific content assists trainers to establish the most effective and holistic compliance program.

  • Evaluating benefits of various delivery methods
  • Building a holistic blended learning program
  • Tailoring methods for audience preference

Patrick Hogenbirk, Global Compliance and Privacy Officer, OWENS & MINOR

 

4:45 RAPID FIRE DEMOS: LEVERAGING LEARNING TECHNOLOGY IN COMPLIANCE TRAINING

Tech Topic 1: Enhancing eLearning with Interactive Policy Delivery
Julianne Brierley, Director, Head of Compliance Learning, NOVARTIS

Tech Topic 2: Mobile Learning without an LMS
Brian Miller, Sr. Director of Compliance & Ethics Training, OTSUKA

 

5:15 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on June 5th. Please note that dinner expenses must be covered by each participant individually.

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We hope to see you at the conference!

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