27 March 2019
12:00 – 1:30 PM EST
“Eliminate Duplication”, “Reduce the Noise” and, “Work
Less in Silos”
Leaders across the
industry in 2019 are driving regulatory professionals towards creation of one
simple, strategy that aligns all of an organization’s risk functions. Using
case-studies, you will explore innovative solutions on how companies are
approaching this challenge by:
- defining governance to ensure risk is managed at the right level,
- ensuring that leaders are empowered and informed to make the right
risk decisions,
-
aligning protective and risk functions, as well as alignment of your
risk strategy with the goals of regulators and interested parties
Learning Levels:
Intermediate: Content is designed based upon the assumption that individuals
have basic knowledge of the topic(s) and/or demonstrated
competence related to the topic(s). Higher-level concepts are
introduced during lectures; exercises requiring synthesis and/or application of
concepts are incorporated into the activity.
Learning Objectives
Upon the webcast's conclusion, you will be able to:
- define risk strategy and understand why it is critical to the
effective functioning of your organization
- articulate the challenges and development of an aligned risk strategy
- understand methods by which teams can build alignment across
protective functions throughout the enterprise and align them towards a
consistent risk strategy
- acknowledge the challenges in communicating risk information,
highlight potential opportunities to communicate more effectively across the
organization, and provide information in a form that can support leadership
decisions
- understand the importance of a clearly defined governance hierarchy
and thresholds, to ensure risk is managed at the right level
- consider the impact of the organization’s risk strategy decisions on
its relationship with regulators and opportunities to communicate the rationale
behind the organization’s risk strategy
Who Should Attend?
-
head of regulatory functions (compliance, medical quality, audit,
submissions)
- divisional leaders (r&d, commercial, product)
- risk management functional leaders / teams (ERM, Quality Management
System leads)
Speakers
Brian Riewerts, risk and
regulatory partner, PricewaterhouseCoopers LLP
Brian
Riewerts is a partner in PwC's Advisory Practice and has global responsibility
for PwC's Life Sciences governance, risk management and compliance practice.
With over eighteen years of experience, Riewerts focuses his practice in the
areas of compliance and enterprise-wide risk management program strategy and
design, compliance auditing and monitoring, and CIA/IRO negotiation and
implementation support. He is a frequent speaker and author on regulatory and
compliance issues related to the pharmaceutical, bio-technology, and medical
device industries.
Other Speakers TBA
Webcast registration includes access to handouts, presentation slides
and the on-demand recording for one year.