Efficient, effective, independent: Getting the most out of your legal rep
For any study conducted in the EU by a non-EU sponsor, there is a requirement to have a legal representative. While you can choose to appoint a different legal representative for each study, there are efficiencies of scale to having the same representative across them all. However, if you select to use a legal representative […]
IDEA Origins and the Legal Representative
Why IDEA set out to provide sponsors with a trusted, independent EU legal representative While the Clinical Trials Regulation has clarified the role of the legal representative, IDEA Regulatory’s founder Dr Francisco Harrison recognised early on that it was more complicated and involved than many sponsors and CROs interpreted it to be. Having supported clients […]
The Importance of QMS and Vendor Oversight for Non-EU Sponsors Under The CTR
Good clinical practice is well-entrenched in global biopharmaceutical companies, and almost every sponsor company adheres to the Declaration of Helsinki with regards to following ethical principles in their medical research. For US companies, the standards established by the Food and Drug Administration (FDA) are very much in line with what is required in the European […]
Independent Oversight: Why It’s a Risk to Have Your CRO as Your Legal Representative
In theory, there is no reason and nothing in the Clinical Trial Regulation (CTR) that prevents a contract research organisation (CRO) being named as the EU Legal Representative by a Sponsor. However, it does beg the question as to whether there would be a conflict of interest, since what it means is the sponsor is […]
Asking the Right Questions: Staying Ahead of the CTR and MDR with the EU Legal Representative
The EU legal representative plays a unique role in the life sciences industry and requires a distinctive skill set – with a background in regulatory affairs and quality assurance, but from inside the good clinical practice (GCP) sphere. Now, with the added complexity of the Clinical Trials Regulation and the Medical Devices Regulation, the role […]
The QA to the Sponsor’s QA: Why the Legal Representative Should be Separate from the CRO
The role of the legal representative for clinical studies – both in pharmaceuticals and now in medical devices under the EU Medical Devices Regulation (MDR) – might be described as quality assurance of the sponsor’s QA role. In future, under the new EU Clinical Trials Regulation (CTR) and MDR, the legal representative will be responsible […]
Why “Ensuring” the Sponsor’s Compliance is Not the Right Role for CROs
The Medical Devices Regulation will bring massive and rapid change to the industry. Not only must companies adjust to new clinical investigation requirements, but they will suddenly find themselves in need of a number of new experts. Medical device companies wanting to run clinical investigations of their products in Europe will need a qualified person […]
This Changes Everything: MDR and the Role of the EU Legal Representative
The medical devices industry has changed dramatically in recent years. Historically, medical devices had more in common with product manufacturing industries such as aviation, which meant testing and standards were very engineering focussed: Is the product built robustly? Are the materials adequate for their intended purpose? Will the product and materials last? While those standards […]