DAY TWO | THURSDAY, JUNE 6TH
8:00 REGISTRATION & WELCOME COFFEE
8:40 CHAIRPERSON’S OPENING REMARKS
Brian Oderkirk, Director, Risk Management Services, SECOND CITY WORKS
8:45 MASTERCLASS: EFFECTIVELY MAINTAINING TRAINING PRIORITIES UPON EXITING A CORPORATE INTEGRITY AGREEMENT
Following a Department of Justice (DoJ) and Office of the Inspector General (OIG) investigation, many pharmaceutical and device corporations enter into a Corporate Integrity Agreement (CIA) which stipulates the content and frequency of training, as well as required auditing and formal reporting for a set period of time. While the conclusion of a CIA is certainly a positive transition, it does not represent an end to the need for continued, comprehensive compliance training and monitoring efforts. With a focus on continued support for compliance training, auditing programs for risk vulnerabilities and maintaining alignment with legal and regulatory guidance, executives will gain insights into continued compliance education.
- Beneficial CIA attributes to support long term
- Maintaining training momentum following a CIA
- Opportunities post CIA for innovation & flexibility
Maureen Mason, Compliance Business Partner, ASTRAZENECA
How long is a microlearning course?
9:30 CASE STUDY: OPPORTUNITIES FOR ENGAGING INTEGRATION OF MICROLEARNING IN COMPLIANCE TRAINING
Trainers develop microlearning courses to train and retrain tenured employees on established compliance material or educate stake¬holders on updated policies and regulations, often when an hour long module might not be the most practical or necessary method. Compliance trainers evaluate the risk of educational content to designate which information is best delivered through microlearning and ensure the overall message can be conveyed within a shortened time period. Although microlearning is a widely applied approach, compliance trainers are still challenged with tracking the sessions to fully identify the outcome on employee comprehension and retention.
- Appropriate content for microlearning based on risk
- Narrowing down content to fit shortened sessions
- Tracking effectiveness through employee retention
Julianne Brierley, Director, Head of Compliance Learning, NOVARTIS
10:00 COFFEE & NETWORKING BREAK MULTI-PART CASE STUDY: CONTEXTUAL COMPLIANCE RISK EVALUATION IN PRIORITIZING TRAINING RESOURCES
With an ever increasing number of compliance risks faced by the pharmaceutical and medical device industry, compliance trainers must take a holistic approach in the allocation of resources, ensuring training meets the current and future needs of the organization, mitigating both legal and regulatory risks throughout the corporation. Conducting a thorough assessment of potential risks and constructing the financial impact of non-compliance prior to allocating resources within training budgets is a forward thinking, proactive approach to ensuring training matches immediate needs. Given the varied volume of resources between smaller and larger corporations, as well as different levels of risk tolerance, presenters will share the process behind resource allocation, providing insights into strategy, decision making, and ultimately, results.
- Evaluation of risks within corporate structure
- Monetizing risks to support resource allocation
- Prioritizing financial & staff resources accurately
10:30 CASE STUDY 1: LARGE CORPORATION PERSPECTIVE
Jessica Seifert, Director, Commercial Compliance Operations, ABBVIE
11:00 CASE STUDY 2: MID-SIZED CORPORATE PERSPECTIVE
11:30 CASE STUDY: DEVELOPMENT OF COMPLIANCE TRAINING WITH LIMITED RESOURCES
As companies continue to expand, the potential for gaps in training processes heightens while resources allocated to compliance training teams often remain the same. In an evolving work environment, compliance issues pose a serious risk to a company’s enduring success as training officers struggle to meet an organization’s needs within the limitations of a small team. Taking on these challenges has led to new methods of risk analysis as well as the development of data collection and communication technologies, providing compliance officers with an abundance of effective tools to balance costs while achieving the goals of a growing company.
- Balancing cost against effectiveness
- Identification of high cost risk
- Low cost tools & digital partners
Brian Miller, Sr. Director of Compliance & Ethics Training, OTSUKA
12:15 LUNCHEON FOR ALL PARTICIPANTS
1:15 BREAKOUT GROUPS: COMPLIANCE CONSIDERATIONS SPECIFIC TO PHARMACEUTICAL & MEDICAL DEVICE ORGANIZATIONS
It is widely recognized that the pharmaceutical and medical device companies are aligned with many regulatory requirements, however, each industry encounters varying levels of intensity for compliance efforts. This peer-to-peer learning session allows compliance trainers to dive deeper into specific concerns surrounding regulatory and legal requirements as well as the unique effects on each individual industry. To allow for insight and to review multiple topics, delegates will have the opportunity to join two groups throughout an hour long deep dive into current compliance concerns for the life science industries.
PHARMACEUTICAL INDUSTRY BREAKOUT TOPICS:
- Off-Label Marketing & The False Claims Act
- The Physician Payments Sunshine Act
MEDICAL DEVICE FOCUSED BREAKOUTS TOPICS:
- The Physician Payments Sunshine Act
- Updated Advamed Code of Conduct
Lacey Daugherty, TELEFLEX
- Compliant physician interaction & “no touch”
- The EU General Data Protection Regulation
Gwen Chapman, TELEFLEX
2:15 CASE STUDY: MANAGING DISTRIBUTOR PARTNER COMPLIANCE TRAINING
When a life science organization partners with a third party, the compliance training department must ensure the external stakeholders are abiding by internal policies and requirements, in addition to behaving in a compliant manner with federal regulations to mitigate noncompliance liabilities. Often, third parties will have compliance teams and programs to educate employees, however, the life science organization continues collaboration to form agreements and in some cases must establish a new training program for the third party. Life science teams utilize various measures to track compliance in third party organizations as well as remaining updated on new external employees to train.
- Contract Research Organizations
- Distributor partners
- International affiliates
- Contracted employees
- Internal procurement
Gretchen Cseplo, Compliance Officer, U.S., Canada & Director, Global Compliance Operations, CONVATEC
2:45 COFFEE & NETWORKING BREAK
3:00 BUILDING A COMPLIANCE TRAINING PROGRAM FOR A GLOBAL AUDIENCE
As the pharmaceutical and device industries continue to grow and companies expand globally, training executives are faced with the responsibility to not only maintain awareness of compliance risks existing in specific countries, such as bribery and corruption practices, but also regulatory requirements in certain regions, such as the EU General Data Protection Regulation. Compliance programs need to be redesigned to suit global staff members, sometimes requiring multiple adjustments for numerous regions. To deliver clear expectations of policies, training material must be translated correctly while maintaining the desired message, in addition to appropriately distributing the content to accommodate specific needs of the region.
- Focus on anti-bribery & anti-corruption training
- Collaboration with global staff to adjust material
- Effective localization of compliance materials
Daniel Simon, Director, Compliance, STERIS CORPORATION
3:45 WORKSHOP: TRAINING STRATEGIES FOR INSTILLING ETHICAL BEHAVIORS
While the ethics tone of an organization is often set by executive leadership, compliance trainers shoulder the responsibility of distilling this tone to all members of staff, ensuring alignment of behavior and communication with the ethical standards set by the organization. This workshop gives attendees the opportunity to collaborate in small groups, discussing optimal training strategies for real world examples of noncompliant behavior and hear from other professionals on how to best implement corrective training measures. The groups will then reconvene to report on the provided scenarios and share solution methods.
SUGGESTED WORKSHOP TIMING:
- 10 minutes: Presenter introduction, setup & small group introduction
- 25 minutes: Small group collaboration, discussion of solution methods
- 10 minutes: Reporting corrective solutions to the group
Heather Hurst, Director, Global Ethics & Compliance, COOK GROUP
4:30 CLOSING REMARKS & CONFERENCE CONCLUSION