Regulation in Life Sciences
Turning complexity into opportunity
Change continues to shape the regulatory landscape for life sciences. Uncertainty prevails where markets shift and stakeholders try to understand change — making the need to plan more urgent than ever. From increased scrutiny of data integrity to the tracking of medicinal products, to changing political landscape and policy changes, today’s shifting regulatory priorities will need to be front and center as you develop your compliance strategies, actions and investments..
By developing strategies to address regulatory compliance, life sciences companies should be able to transform compliance activity from a cost to value creating process that delivers sustainable competitive advantage. Deloitte can deliver for you on this journey by supporting the development of your regulatory compliance strategy, performing compliance tasks in partnership with you, and enhancing the maturity of your compliance function.
2017 LS Regulatory Outlook
Published by the Deloitte Center for Regulatory Strategy-Americas, this annual, cross-industry series focuses on the year's top regulatory compliance trends. The issues covered provide a starting point for important dialogues about regulatory challenges and opportunities.
IDMP
Learn the latest about the identification of medicinal products (IDMP) regulations— one the largest regulatory challenges for pharmaceutical companies operating in Europe. How can companies navigate this journey towards increased patient safety and use it as an opportunity for business transformation?
EU regulatory landscape
European regulatory changes will likely affect every pharmaceutical, biotechnology, or medical technology company that currently sells or sponsors products in the European Union. Companies need to take a proactive approach to monitoring and understanding EU regulatory developments and their impact.
Medical Devices
A range of new medical device regulations promises to impact all device manufacturers. Understanding the scale and complexity of that impact will be critical to how manufacturers responds—from both an operational and risk perspective.
Data Integrity
Due to an increase in data manipulation in pharmaceutical manufacturing facilities, regulators globally are focusing on enforcing principles and practices to ensure product quality and patient safety. In this climate of increased scrutiny, it is essential that companies dedicate themselves to good data practices—not only for compliance purposes but also to support sound, strategic decision-making.
Master data management for pharma product data and information
In addition to achieving compliance, master data management (MDM) can bring many benefits to pharmaceutical companies. Learn how MDM can help your organization improve speed and efficiency across the product life cycle.
Center for Health Solutions
The source for fresh perspectives in health care, The Deloitte Center for Health Solutions is the research division of Deloitte's Life Sciences & Health Care practice. Located in Washington, D.C., and London, they develop cutting-edge research and thought-provoking analysis to give industry insiders the insights they need to see things differently.
Center for Regulatory Strategies
Through regular dialogue with institutions, trade associations, and other regulatory stakeholders, the Center for Regulatory Strategies-Americas helps Deloitte clients understand regulatory policy in financial services, health care, life sciences, and energy in the Americas region.
Health Care Current
This weekly series explores breaking news and developments in the US health care industry; examines key issues facing life sciences and health care companies; and provides updates and insights on policy, regulatory, and legislative changes.
The bigger picture
Impact of EU regulatory change on the global life sciences industry
Recent and ongoing European regulatory changes will impact every pharmaceutical, biotechnology or medical technology (medtech) company that currently sells or sponsors products in the European Union (EU). Companies can be well-equipped by taking a proactive approach to tracking and monitoring the regulatory developments and understanding their independent and combined impact on the business.
Under the spotlight
Data integrity in life sciences
Regulatory bodies now have high expectations with regard to data quality and integrity owing to the life sciences industry’s growth, globalization and adoption of advanced technology, such as highly automated systems and storage of data in ‘The Cloud’. Good data practices will enrich the quality of data, allowing life sciences companies to make strategic decisions backed by analytics and data-driven insights.
The future awakens
Life Sciences and Health Care Predictions 2022
The year is 2022. The quantified self is alive and well, digital technologies have transformed the culture of health care and new entrants have disrupted delivery models. This report from Deloitte UK's Centre for Health Solutions offers some predictions that, if they come true, will shake up the life sciences and health care industry in the next five years.
Building world-class ethics and compliance programs
Five ingredients to meet global expectations
The ethics and compliance function has evolved over the past decade and it is now front and center with greatly expanded responsibilities. When it comes to creating ethics and compliance programs, organizations today cannot afford to settle for “good enough” and should continuously strive for “great.”
2018 Global life sciences outlook
Innovating life sciences in the fourth industrial revolution: Embrace, build, grow
Unravelling complexity
The challenge of compliance in the life sciences supply chain
In an environment driven by increasing complexity, product diversity and regulatory scrutiny, what are the major compliance risks impacting the entirety of the life sciences supply chain? What opportunities exist to transform compliance from a burden to a source of competitive advantage?
New Horizons
Compliance 2020 and beyond
What will the Compliance function look like in 2020 and beyond? What changes are likely to occur and what challenges might Chief Compliance Officers’ be facing?
