Regulation in Life Sciences


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.

We can support you in the following areas:

  • Third party risk management
  • Including Pharmacovigilance/ Post-marketing Surveillance/ Contract Research Organisation Support with the development of the Compliance Programme for your organisation
  • Ethics & Compliance – Supporting in achieving compliance and reviewing compliance with EFPIA/ IPHA/ ABPI Codes of Practice
  • Support with establishing and reviewing compliance with Pharmaceutical/ Medical Device Industry legislation including:

        - Life Sciences GxP regulations

        - Clinical Trial Regulation (CTR)

        - Medical Device Regulation (MDR)

        - In-Vitro Diagnostic Medical Device Regulation (IVDR)

Validation using Agile in the Life Sciences and Health Care Industry 

Life Sciences and Health Care Industry

The Life Science and Health Care Industry (LSHC) has always been in the lime light for its strict regulations.Though these regulations are cumbersome, they are deemed necessary in order to comply with patient safety and product quality. In line with the strict regulations, the traditional Waterfall Method was always used in Software Development in LSHC industry. The advent of Agile Methodology has disrupted the traditional development methods with its clear focus on continuous development, agility and over all “lean” concept.

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Is the new EU medical device legislation worth the wait?

Understanding the new legislation

Divergence in the interpretation and application of EU rules, advances in technology and a need to respond to incidents such as the PIP breast implant scandal, has prompted the European Commission to introduce new rules for the regulation of medical devices.

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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.

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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.

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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.

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Clinical Trials Regulation

Building a successful program

The new Clinical Trial Regulation (CTR) is set to revolutionize the clinical trial processes across Europe, impacting all European Union (EU) member states and companies that wish to run clinical trials across the region. It is applicable for Investigational Medicinal Products (IMP) for human use and does not apply to non-interventional trials or trials without medicinal products such as devices, surgery, etc. The regulation seeks to provide a single, unified portal and database for both trial sponsors and regulatory agencies in each member state. For sponsors, the portal will be the main platform to submit applications and notifications allowing regulators to conduct their assessments and supervise the trial.

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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?

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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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A bold future for life sciences regulation

Predictions 2025

What might regulation in the life sciences industry look like in the future? We examine the impact of greater collaboration with and among regulators, and the use of digital and cognitive technologies to facilitate a data-driven approach which is driving the productivity and quality of regulation leading to real-time regulation. We believe that Irish life science leaders who binging attention and focus to the areas mentioned above will be better prepared for the future and more able to improve the reputation of the industry with all stakeholders.

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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.”

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Patient access to innovative healthcare in Europe

A collaborative and value-based approach

In light of pressurised healthcare budgets, growth in personalised medicine and increasing requirements to demonstrate value, are current market access models sustainable? New research released by the Deloitte UK Centre for Health Solutions explores the current market access and pricing challenges presented by the European market, and provides recommendations on how pharma companies can work more collaboratively with payers to help patients gain access to the latest medical innovations.

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Contact Us

Eileen Healy

Eileen Healy

Partner - Operational Risk

Eileen Healy is a partner in our Risk Advisory practice specialising in the provision of risk management, compliance, governance and technology assurance services to clients in the life sciences, corp... More

Karen Frawley

Karen Frawley

Partner, Tax

Karen is a partner in the firm’s Tax practice and a member of the firm’s international tax group. She has over 17 years’ experience advising multinational groups investing in Ireland and Irish-based g... More

David Hearn

David Hearn

Global Consulting Leader - Consumer Industry

David Hearn is the Global Consulting Leader - Consumer Industry. David is also the Partner Lead for Technology, Strategy & Transformation and SAP, and has 30 years’ experience in helping clients with ... More