Gondola’s Quality, Regulatory and Clinical Affairs Team
Rima Padovani leads the team as Head of Quality, Regulatory and Clinical Affairs. Her role is to ensure that an optimal regulatory framework is set and that the cross-communication between the three domains of Quality, Regulatory and Clinical Affairs is effective and in line with the company objectives, ensuring market approval of Gondola’s medical devices in the target regions and for the targeted indications.
What are we working on at the moment?
We are currently preparing two main regulatory submissions, one in Europe to obtain the CE certificate under the Medical Device Regulation (EU 2017/745) and one in the US to obtain market approval through a De Novo request. With these objectives in mind, we have 4 main domains of activity:
- 1Quality Assurance, to upgrade our quality management system and integrate it with the new requirements introduced by the Medical Device Regulation (EU 2017/745) and with the requirements set by the Quality System Regulation (21 CFR 820).
- 2Regulatory Affairs, to prepare the technical documentation of Gondola’s medical device to demonstrate compliance with the Medical Device Regulation (EU 2017/745) in Europe and support the De Novo request in the US.
- 3Clinical Affairs, to consolidate the clinical evidence on Gondola’s medical devices through the implementation of the clinical evaluation process, the design of clinical studies based on the output of the clinical evaluation, and the conduct of clinical studies according to GCP.
- 4Scientific Affairs, to investigate the effects of AMPS on Freezing Of Gait, a disabling motor disorder characterized by the temporary inability to move the feet forward despite the intention to walk, in collaboration with the Cologne University Hospital (UKK) in Germany. Providing clinical evidence that Gondola helps to reduce FOG severity significantly is one of our priorities at the moment, as FOG represents today one of the most debilitating motor symptoms in patients affected by Parkinson Disease (as it leads to a progressive loss of independence and increases the risk of falls) and has no efficient treatment yet – especially at late stages.
What are the key milestones for the Quality, Regulatory and Clinical Affairs team in 2022?
Two key milestones for the team are the regulatory submissions for Gondola’s medical device for CE marking under the Medical Device Regulation (EU 2017/745) and for market approval with FDA through De Novo’s request.
In parallel, a third key milestone is the initiation of an exciting research project in collaboration with the Abilities Research Center at Icahn School of Medicine at Mount Sinai (New York) on the AMPS therapy that will start in the first part of 2022.
What excites us the most about our work at Gondola?
We are excited by the therapeutical potential of AMPS, and for us, it’s incredibly rewarding to see the concrete improvement that Gondola brings to our patients’ life. We are both inspired by the innovation and technology behind Gondola, and we are happy to support this product with our expertise in the scientific, regulatory and clinical domains. Our goal is to give a concrete contribution to ensure that our medical devices are available for all those people (affected by Parkinson’s Disease and many other neurological conditions) who could benefit from AMPS therapy.
For any questions related to Quality Assurance and Regulatory, Clinical, and Scientific aspects of Gondola Medical Device and AMPS therapy, don’t hesitate to contact the team at email@example.com