Resources

EUCOPE takes pride in providing expertise in the early perception of future markets and regulatory developments on a variety of topics. Below you will find a list of our resources (position papers, reports, statements, webinars etc) related to our main priorities and working groups.

Resources

Advanced Diagnostics

EUCOPE launches the European Coalition for Access to Comprehensive Genomic Profiling (ECGP)

World Cancer Day: Fostering the EU Advanced Diagnostics Ecosystem to tackle the Cancer Burden

Episode 11 – 2022 Year in Review

Episode 5 – Increasing Access to Genomic Testing in Europe: The role of national genomics initiatives in increasing uptake of Advanced Diagnostics

Pulling out all the stops to deliver high-quality care for European cancer patients (2021)

Episode 2 – Fostering an EU Advanced Diagnostics Ecosystem (2021)

Developing an Advanced Diagnostics Ecosystem in Europe (2021)

Advanced Therapy Medicinal Products (ATMPs)

Hospital Exemption Clause in ATMPs (2024)

Real-World Evidence (RWE) across the Lifecycle of Cell and Gene Therapies (2023)

Launch Conditionality: What’s at Stake?

Episode 11 – 2022 Year in Review

Episode 9 – ATMPs and how they’ll be impacted by the General Pharmaceutical Legislation

Episode 6 – Overcoming Barriers: Improving Access for Rare Disease Patients through Cross-Border Healthcare (2022)

Cross-Border Healthcare for Rare Disease Patients: What Can Be Done? (2021)

ATMPs: New Payment & Funding Approaches (2021)

Gene & Cell Therapy – Pioneering Access for Ground-Breaking Treatments (2018)

The Future of Rare Disease Innovation in Europe

Brexit

Life Science Industry Coalition on BREXIT

Digital Health

Episode 17 – Real-World Evidence (RWE): The need for a multi-stakeholder approach

Episode 11 – 2022 Year in Review

European Health Data Space (EHDS): How will it impact health technology companies operating in or about to enter the EU?

Episode 8 – Ensuring a robust European Health Data Space (EHDS)

Health 4.0. post-COVID – Small and Medium Companies Leading Innovation

Artificial Intelligence in Health (2021)

Economic Off Label Use and Compounding

Compounding Drugs to Lower Costs Puts Patients at Risk (2017)

Compounding Drugs to Lower Costs Puts Patients at Risk (2016)

EU Pharmaceutical Strategy

Life Science Lectures – Episode Three

EU Pharmaceutical Package: A more competitive and attractive EU for smaller companies

Life Science Lectures – Episode Two

Life Science Lectures – Episode One

Episode 14 – Trans-Atlantic Innovation: Building bridges between the EU & US life sciences industry

Launch Conditionality: What’s at Stake?

Episode 11 – 2022 Year in Review

Episode 10 – Launch Conditionality: The impact on small and mid-sized companies

Fostering Innovative Therapies and Technologies in Europe: A Forward Look (2021)

The Modernisation of the Centralised Procedure (2022)

Episode 3 – The European Pharmaceutical Strategy: A patient-centred and future-proof framework? (2021)

On the EU’s General Pharmaceutical Legislation

EC Pharmaceutical Strategy – Time for a Modern Approach to Value (2020)

Health Emergency, Preparedness & Response Authority (HERA)

EU-wide Stockpiling: Better Preparedness for Cross-Border Health Threats

Health Technology Assessment (HTA)

Life science industry concerns over workability of EU HTA

Life Science Lectures – Episode Four

Life Science Lectures – Episode Three

Episode 17 – Real-World Evidence (RWE): The need for a multi-stakeholder approach

Episode 12 – Preparing for the new EU HTA Procedure

Episode 11 – 2022 Year in Review

Concerns over the Implementation of the EU HTA Regulation

Policy Brief | The EU HTA Procedure

Five Priorities for a Successful EU HTA Procedure

EUCOPE’s 5 EU HTA Priorities (2022)

Statement on EU HTA Portuguese Presidency Compromise (2021)

Episode 1 – A Future-proof HTA System in Europe? (2021)

On Commission’s proposal for a Regulation on HTA (2018)

EU Cooperation on HTA (2018)

Life Science Lectures (LSL)

Life Science Lectures – Episode Four

Life Science Lectures – Episode Three

Life Science Lectures – Episode Two

Life Science Lectures – Episode One

Medical Devices & IVDs

Episode 15 – MDR/IVDR Amendments: Implications for EU medical device companies and patients

Medical Devices Regulation (2015)

In Vitro Diagnostic Medical Devices (2013)

Orphan Medicinal Products (OMPs) & Paediatrics

Life Science Lectures – Episode Two

Episode 16 – Rare Reflections: Impact of OMP Revision on rare disease companies

Rare Disease Day 2023: A Shared Vision for the EU Rare Disease Ecosystem

Episode 13 – Rare Disease Day 2023

Launch Conditionality: What’s at Stake?

Policy Brief | The OMP Regulation

Episode 11 – 2022 Year in Review