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
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.
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)
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.
Need Assistance? Contact the RAPS Solutions Center at +1 301 770 2920, ext. 200.