Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024...more
Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including:
- The EU’s new Unified Patent Court...more
6/17/2024
/ Artificial Intelligence ,
EU ,
Financial Regulatory Reform ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector ,
Unified Patent Court
On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more
As macroeconomic forces and geopolitical dynamics continue to shape the M&A and investment climate globally, health and life sciences transactions continue to remain high priority sectors presenting both high growth and...more
9/15/2023
/ Acquisitions ,
Austria ,
Capital Markets ,
Denmark ,
France ,
Germany ,
Global Market ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Investment ,
Investors ,
Italy ,
Jurisdiction ,
Life Sciences ,
Mergers ,
Netherlands ,
Poland ,
Regulatory Agenda ,
Spain ,
Switzerland ,
UK ,
United States
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more
In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more
3/3/2023
/ Data Collection ,
Data Protection ,
Data-Sharing ,
EU ,
European Economic Area (EEA) ,
General Data Protection Regulation (GDPR) ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Personal Information ,
Regulatory Agenda ,
UK
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community.
Join us for insightful discussion about the latest regulatory and reimbursement developments....more
2/1/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Laboratory Developed Tests ,
Legislative Agendas ,
Medicare Administrative Contractors (MAC) ,
Prior Authorization ,
Regulatory Agenda ,
Reimbursements
MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION -
The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more
4/29/2022
/ Clinical Trials ,
Data Privacy ,
Data Security ,
Data Transfers ,
Draft Guidance ,
EU ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Privacy Laws ,
Regulatory Agenda ,
Research and Development ,
UK
The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more
The UK Government has proposed changes to the procurement regime for public sector contracts in the UK. The proposals mark a radical divergence from the European procurement regimes post Brexit. The proposals are set out in a...more
On February 19 2021, the European Union Commission issued its draft adequacy decision for data flows between the European Union (EU) and United Kingdom (UK).
Whilst widely expected, this draft decision will provide some...more