On-demand recording from 27 March 2019. The recording will be accessible in your Learning Portal account up to 48 hours after the webcast.
“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.
Stephanie Ring, senior director, medical quality assurance, business process and strategy, Pfizer
Stephanie Ring is a senior director of medical quality assurance, business process and strategy at Pfizer. Ring leads a team of colleagues responsible for the design, development, implementation and continuous improvement of global, strategic and operational initiatives in support of the departments long-term vision and strategy. In addition, Stephanie is the co-lead for driving the strategic approach to the R&D risk strategy for Pfizer, influencing and facilitating partnerships across functions and divisions enabling a high quality MQA audit program and oversight of R&D activities.
Andrew Austin, manager, pharmaceutical and life sciences practice, PricewaterhouseCoopers LLP
Andrew Austen is a manager in PwC's Pharmaceutical and Life Science’s Risk & Regulatory Practice based in New York. Austen joined PwC in 2013 and during his six years there, he has acted as a trusted advisor to clients in healthcare, pharmaceuticals, technology, consumer products, air transportation, asset management and financial services. His role has covered project and program management, process mapping and business continuity management. Austen’s experience also includes supporting risk strategy projects, including supporting the development and implementation of a cross-line of defense risk strategy and operating model.
Megha Sinha, manager, pharmaceutical and life sciences practice, PricewaterhouseCoopers LLP
Megha Sinha is a seasoned manager with PwC’s Pharmaceutical and Life Sciences Practice primarily focused on regulatory strategy and operations, pharmacovigilance and quality, and is based in San Francisco. She has almost ten years of experience working with healthcare, medical devices and life sciences companies. Sinha has a Master’s in chemical engineering and biomedical engineering from University of Southern California. She also has Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.