Insights

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.

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?

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