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
- In-Vitro Diagnostic Medical Device Regulation (IVDR)
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.
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.
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.
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.
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.
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?
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.
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.”
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.