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Life Sciences Regulatory & Compliance

PwC professionals help you to respond to the complexities of today and tomorrow

EFPIA Report Submission

30. 6. 2021

PwC has many years of experience supporting international Life Science companies to comply with their respective worldwide compliance program.  We offer in-depth knowledge and integrable software that helps clients to meet and enhance any compliance requirements.

No matter how large, small or diversified your organisation is, almost every part of it is connected to a complex web of constantly evolving regulations. Failing to comply results in the risk of enforcement actions, fines or reputational damage. Your regulatory response reflects the level of control and maturity you have in your business.

Compliance is more than just prevention. It’s also about navigating through different opportunities. Opportunities which can strengthen your organisation through strategic, proactive measures such as best practices, employee training, internal controls, and benchmarking appropriate for your industry and company size.


Recipient Engagement

Interactions Hub, a PwC Product, is a one-stop-shop solution built on Appian's low-code automation platform for managing HCP, HCO and patient interactions such as consulting engagements, grants, speaker programs, and expanded access programs. Through Interactions Hub, PwC can digitize the end-to-end process of your company to cover the entire lifecycle of the engagement process.  Interaction Hub links with your peripheral systems, and with PwC spend transparency, analytical and regulatory solutions, offering you an holistic view of your interactions starting from the budgeting phase through to the event closure.

Digital enablement HPC / HCO


The right blend of technology and industry expertise, Interactions Hub increases efficiency with a streamlined recipient management system that reduces manual steps and redundancies. It also facilitates seamless and proactive compliance.

True digital enablement of the HCP ("healthcare professional") / HCO ("healthcare organisation") / Patient organization engagement process for pharmaceutical and life science companies can be game-changing and result in:
Proactive Compliance: Systematic, preventative controls provide consistent and compliant execution of funding and grant requests and HCP engagements, globally
Business Efficiency & Quality: Increase resource efficiency through automated and streamlined processes while unlocking value through improved data analytics and dashboarding capabilities
Enhanced HCP / HCO Experience: Simplified interactions and reduced touchpoints with HCPs/ HCOs results in a better user experience and increased focus on driving strategic value in the HCP/ HCO partnership.


Interaction Hub serves as your guide for business processes and rules and enables you to operate a unified business and compliance environment.


  • HCP/HCO Engagement process overview
  • Documentation Review
  • Project Management
  • Process Improvements
  • Risk and Gap Analysis
  • In-depth Review
Digital enablement HPC / HCO

We can help your company to achieve value and gain benefits and efficiency through the entire HCP/HCO Engagement cycle.

Spend Transparency Reporting

Transparency in the relationship between life science companies and healthcare professionals (HCPs) as well as organisations (HCOs) has become significantly crucial to the reputation and credibility of pharmaceutical companies globally – irrespective of but simultaneously supported by spreading country-specific legislative or regulatory pressures. The legislative framework worldwide is growing constantly, geographically and in complexity and pose new risks of missing compliance deadlines, compromising company reputation and fines associated with incorrect information reported. PwC has created services that address the implementation and monitoring of transparency, the rules of which have been in force for some years that could help your company to effectively manage a worldwide transparency program.

Transparency reporting

Our solution to simplify and deliver 100% of transparency reporting

Transparency hub

Next generation transparency and analytics cloud solution designed both for outsourcing or client use.

Automated end-to-end transparency reporting

Transparency Hub is a true all-in-one, cloud-based solution for global transparency reporting. Built by experienced professionals, it speeds and simplifies reporting.

Transparency approach will move your business forward as you will
Reduce Compliance & Reputational Risks: Meet all the requirements and deadlines in transparency reporting and compliance. Increase your reputation and strengthen your competitive position as a more respectable and trusted company.
Increase Efficiency: Constantly update to the latest status, trends, changes and new requirements set by European standards. Ensure data completeness and quality.
Employ State-of-the-Art Analytics & New Insights: Covering cross-border activities to expand in other countries and markets. Improvements and recommendations for data processing and analytics in marketing, business and finance.

Different models can be offered to help companies achieve their disclosure targets. Based on client’s requirements, the extent of services can comprise

  • Transparency-as-a-Service
    • Partial Outsourcing
    • Complete Outsourcing
    • Ad Hoc Reporting Support
  • Project Management
  • Process Improvements
  • Employee Training
  • SOP Creation
  • Risk and Gap Analysis
  • In-depth Review


Transparency reporting

Detection and Monitoring Hub, a PwC Product, identifies compliance insights, target high-risk activities in rapidly changing markets and better allocate your resources accordingly through the application of advanced analytics and machine learning.
Additionally, data gathered for reporting can be further utilized and analyzed exceeding the compliance purposes. Get more information about our Data & Automation capabilities here.

Regulatory Support Services

IDMP

Identification of Medical Product (IDMP) is a significant data standardisation challenge for pharmaceutical companies, aiming at a unique identification of medicinal products. European Medicines Agency (EMA) is the first of those who decided to mandatorily adopt these new ISO standards. Meaning that after a regional deadline (expected in 2022-2023), all pharmaceutical companies operating in the European Union must comply with IDMP regulations. Other regions (including the United States and Japan) are expected to provide their deadlines gradually. Although timelines for IDMP implementation have been shifted, it is inevitably coming to the final stage as EMA released version 2.0 of the EU IDMP Implementation Guide (EU IG v2.0) in February 2021, disclosing more details on how to proceed with compliance preparations. For those who have not launched their IDMP projects yet, or are at the initial stage, this is the right time to mobilise. Staying idle is not an option.

We support our clients in their efforts to unlock the power of product data thanks to IDMP, and transform their business and improve patient health by:

  • Understanding IDMP, its impact and benefits specific for their organisation
  • Setting up a short/long-term strategy
  • Mapping all the resource systems and data
  • Implementing solution fitting your business needs
  • Supporting at maintenance

Our experience with master data management alignment and the implementation of EFPIA HCP/O transparency reporting regulations showed a reduction in program and operational issues related to key master data as well as ensuring that regulatory requirements are met. Even greater potential now lies within the building blocks of IDMP standards.

Support of Registration Management

We understand that the regulatory environment is complex enough, and we are continuously striving to find solutions for the purposes of simplification and effectiveness. Registration-related fees have a significant impact on the planning and financial lifecycle of each product.

We can help you to:

  • Consolidate input from different regulatory sources across countries to ensure their up-to-date overview and reduce manual workload;
  • Monitor & maintain the whole regulatory budget so you can quickly react to changes;
  • Easily explore & compare options to determine the most suitable registration strategy.

Requirements that registration documents are of a higher quality are increasing, and thus companies should thoroughly deal with deficiency letters from regulators in order to minimise prolonging timelines or to avoid withdrawal of registration.

We can help you to:

  • Forward all deficiencies received or comments from regulatory authorities to a database and to utilise the lessons learned to become more efficient;
  • Connect to a powerful analytical tool to perform evaluations and generate customised visualisations and dashboards providing meaningful insights.

Business Support Services

Strategic Visioning

We partner with our clients to strategically envision the future of their regulatory & compliance activities. Defining the difference between the current state and the desired future state is the first step in planning a successful program enhancement initiative. After performing a discovery exercise, PwC can develop a project roadmap to achieve the client’s goals.


Process Optimization & Operational Support

PwC’s Process Optimisation & Operational Support helps you achieve your business objectives by fulfilling key talent gaps and delivering global support. PwC can provide a deep pool of global, industry-dedicated service delivery resources with a strong understanding of local laws and requirements, and requisite language capabilities. Our industry-dedicated teams and service delivery centres are equipped to support your specific program needs.


Data Analytics

As an integral part of our services we provide our clients with solutions employing powerful analytical tools to optimise their data assets and maximise output of their data which enable faster and better decisions. To get more information about Data&Automation, click here.

Alteryx
Tableau
PowerBI
PowerBI
Qlik
Qlik

Tax & Legal Services

The pharmaceuticals industry in the Czech Republic is characterised by a high degree of foreign ownership. Pharmaceuticals companies operating in the Czech Republic are subject to an extremely strict and complex regulatory environment. The Czech State Institute for Drug Control (Státní ústav pro kontrolu léčiv) regulates every aspect of business, from pricing to packaging, from clinical trials to advertising.

PwC' pharmaceuticals experts are among the top specialists in the country and can provide sound advice with regards to the tax, legal, and regulatory issues affecting this industry.


Industry issues

  • State regulation of pharmaceutical prices, resulting in limited margins
  • Requirement for alternative financing of operations, which can result in stuctures, which are risky in terms of compliance with price regulation rules
  • Advertising regulation regarding sponsoring, provision of gifts, pharmaceutical samples, etc.
  • Regulation of the distribution of pharmaceuticals
  • Intellectual property protection
  • Return on R&D investment
  • Proliferation of licensing and co-marketing agreements

Industry-specific services

  • Tax advice related to the registration of pharmaceuticals and clinical trials
  • Advice on the tax treatment of the provision of samples, gifts and discounts, including ‘in-kind' discounts
  • Regulatory compliance services and risk management

Want to get deeper insight into the specific topics below?

  1. HCP/HCO Engagement & Spend Transparency Reporting Services
  2. Regulatory Support Services
  3. COVID-19 Response

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Contacts

Stanislav Novák

Stanislav Novák

Business development, PwC Czech Republic

Tel: +420 603 459 510

Ondřej Svoboda

Ondřej Svoboda

Senior Manager Life Sciences Regulatory & Compliance, PwC Czech Republic

Tel: +420 739 673 802

Roberto Tinella

Roberto Tinella

Manager Life Sciences Regulatory & Compliance, PwC Czech Republic

Tel: +420 731 643 672

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