While Clinical Evidence Reports have been required for all medical devices in Europe and Australia for some years, an increasing number of global Regulators are now looking more closely at Clinical Evidence Reports in support of a device’s safety and efficacy.
This has naturally led to an increased level of scrutiny by the regulators on Clinical Evidence Reports, which has been heightened particularly with the implementation of the Medical Device Regulations (or MDR) in Europe and the increasing interest and awareness of the public in the safety and efficacy of the devices they are being provided.
This webinar first introduces the concept and definition of a Clinical Evidence Report and describes how it applies to the regulations in the key market areas of Europe, Australia and the USA. It discusses the differences and similarities of Clinical Evidence Reports in these jurisdictions and explores the intricacies behind the use of indirect and direct clinical evidence in the context of supporting a device’s safety and efficacy.
In addition, the webinar highlights those key aspects of discussion on which manufacturers and sponsors should focus their efforts and provides guidance in navigating the development of a Clinical Evidence Report that comprehensively meets regulatory requirements. It also addresses regulators expectations, including those that may not be expressly written into the legislation or guidance.
The webinar presents on four key aspects of CERs: Clinical Trials, demonstration of equivalence, literature reviews and analysis of post-market data. These are critical components of Clinical Evidence Reports, and those which are often misunderstood by authors. The webinar explores what these aspects mean for Clinical Evidence Reports and how they can be applied, delving deeper into key parameters and considerations. To conclude, there is discussion on the common points to consider when analysing data and incorporating these within a clinical evidence report.
Heyam Kalla is an experienced Medical Devices regulatory professional having held RA and QA roles in a multinational implant manufacturer and her current position as a senior consultant.
She is experienced in regulatory pathway, planning and strategy for ANZ markets, preparation of regulatory filings, management of regulatory reviews and postmarket compliance management for a variety of devices, including high risk products. She has particular expertise in orthopaedic devices and in the preparation and review of Clinical Evaluation reports for medical device and IVD clients for Australian and European markets.
Heyam has also served the Asian Harmonisation Working Party (AHWP), particularly in the area of preparation of guidance on electronic labelling.
Heyam was awarded a Bachelor of Science with a double major in pharmacology and medical microbiology and immunology with first class honours in pathology from UNSW.