November 9-10, 2021 | VIRTUAL EVENT

AGENDA – ALL TIMES ARE IN EASTERN TIME

  • Examine the evolving regulations of the FDA surrounding digital health technologies
  • Monitor advanced manufacturing technologies to and their effects on public health monitoring
Beth KrewsonChief Legal and Compliance Officer, INNOCOLL PHARMACEUTICALS LIMITED
As a result of the COVID-19 virus, the usage of telehealth has developed at a rapid pace. With no signs of slowing down, legal departments of pharmaceutical and biologics companies must ensure they stay ahead of ever-evolving regulations and legal challenges.

Topics of discussion will include:
  • Create and implement digital safeguards surrounding the use of telehealth to meet government regulations
  • Develop ethical partnerships with telehealth providers to offer patients rapid access to necessary services
  • How will telehealth change in a post-COVID environment?
Gabriela Klasa, Senior Legal Director – Specialty Care, IPSEN PHARMACEUTICALS
Maintaining the privacy and confidentiality of patient data always was, and will always remain a main point of focus within the life sciences space. With continuous innovation and digitalization within the sector, now more than ever legal teams must be aware of the risks and liabilities associated with patient information.

Topics of discussion will include:
  • Maintaining compliance with HIPPA, HIA, GDPR and state regulations surrounding the collection and storage of EMR’s
  • Selecting the proper technologies to protect patient data stored on the cloud from ransomware and cyber attacks
  • Implementing technologies to monitor the usage of  a “Digital Health Pass” to ensure ethical usage
John Baumann, Associate Vice President for Research Compliance, INDIANA UNIVERSITY
Bethany Johnson, University Director, Human Research Protection Program, INDIANA UNIVERSITY
Legal departments are typically looked to for safeguarding the enterprise. In addition to managing risk and compliance, legal departments have the opportunity to also focus on operational efficiencies and business performance.

Topics of discussion will include:
  • Methods of problem-solving, legal processes, metrics, technology, and data management
  • Incorporate traditional methods of work into a digital environment
  • Develop metrics and ensuring customer satisfaction to meet the  needs of the business
Neil BelloffChief Operating Officer and General CounselELOXX PHARMACEUTICALS
Kristi Gedid, Managing Director, EY LAW
Kyle McNeil, Law Markets Leader, Americas, EY LAW
While in the past pharmaceutical companies had separated departments into “silos” which rarely interacted with each other, this is no longer the case.  For the purposes of advancement, today’s industry sees the need for continuing collaboration, led by a company’s legal department to ensure an uninterrupted workflow.

Topics of discussion will include:
  • Build an efficient and effective business model of cross-departmental collaboration
  • Develop and implement legal tools and strategies to support new technologies and innovations
  • Examine the evolving project management practices of legal teams and their overall effect on collaboration
Nathan Miller, Legal Operations Analyst, GILEAD SCIENCES
Stephanie Wingrove, VP & Global Head of Ethics and Compliance, GALAPAGOS
David WoodChief Legal Officer and General Counsel, PSYGEN INDUSTRIES

Moderator:
Kristi Gedid, Managing Director, EY LAW
COVID-19 has changed the way companies function within the life sciences space. White their adaptation has been a swift and effective one, agreements to and the implementation of clinical trials have seen a complete transformation to a virtual environment.

Topics of discussion will include:
  • Discuss e-technologies utilized to review these contracts to ensure clearly defined roles for both sites and sponsors
  • Utilize virtual methods to ensure an understanding of and agreement to patient consent documentation
  • Define the role of a third party within the trial agreement and the access they have to select data records
Constant analysis of risk is a critical part of the life sciences space. Improperly building a set of metrics or developing key KPIs are some of the main factors in determining the success and profitability of a company. With opportunities to digitize risk analysis, the automation provides companies the opportunity for time saving and accurate results.

Topics of discussion will include:
  • Institute a system of risk based metrics meant to analyze measures of risk tolerance, incident and controls and mitigation
  • Develop a system of KPIs to measure ongoing performance against previously set benchmarks
  • Utilize artificial intelligence to automate the contract review process to categorize results in predefined classes of risk
Jerry Levine, Chief Evangelist and GC Americas, CONTRACTPODAI
With the ever growing use of wearable technologies, including items such as blood pressure monitors and glucose meters, we see an increase in the number of potential liabilities facing manufacturers. With this in mind, manufacturers must be prepared for all legal challenges, including class action suits.

Topics of discussion will include:
  • Assess risks related to defective designs of a product, inadequate warnings, software malfunctions and incorrect readings
  • Examine potential liabilities surrounding software vulnerability and cyber security threats associated with data tracking
  • Explore settlements surrounding the production and sale of wearable technologies and biomarkers
When picking up a prescription, the first thought of many is standing in line at a local pharmacy. However, innovation has seen the transformation of the pharmaceutical industry to a virtual environment. The amount of individuals filling prescriptions via the internet has grown exponentially, and with that legal teams must ensure their company’s meet the set of regulatory requirements prior to dispensing.

Topics of discussion will include:
  • Evaluate the usage of “cyber doctors” and validating the information they must collect prior to writing electronic prescriptions
  • Ensure compliance with DEA guidelines regarding the dispensing of controlled substance in a virtual environment
  • Exploring the risks involved in the importation of medications from Canada via online platforms
While due diligence is nothing new to legal teams when it comes to the M&A of corporations, the process has traditionally lagged and delayed both the merger and the production of essential pharmaceuticals manufactured by the acquired company. With newly developed technologies, we have seen a rapid growth in the time for these processes to be completed, allowing the workflow process to remain intact.

Topics of discussion will include:
  • Examine electronic FDA records of patent and exclusivity arrangements prior to the merger
  • Assess digital reports of adverse event reporting and the need for warning labels
  • Review prior marketing and sales records, including a review of government reimbursement forms, promotional review and potential violations of the anti-kickback statute
Paul KonneyExecutive Vice President, General Counsel and Head of Global Regulatory AffairsMETAGENICS
One thing we all realize is that the next digital innovation in the life sciences space will be coming rather soon. While we may not know exactly what it is as of yet, we must be prepared to set the groundwork for it. Reviewing company policies and legal protections is essential when preparing for the next wave of the future.

Topics of discussion will include:
  • Review ethical questions related to accountability, transparency and consent in the usage of artificial intelligence
  • Ensure a company’s intellectual property rights over their AI developments, as well as their rights to use the AI technologies
  • Adjust compliance programs to ensure employees receive the proper training for working with these technologies
Vahan MinassianDirector, Digital Compliance, PFIZER

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