Current position and relevant professional experience:
I am currently the Regulatory Director at Endomagnetics Ltd based in Cambridge, a high technology medical device company offering surgically invasive cancer care products. In this capacity I head the companies efforts in achieving regulatory approval in all regulatory jurisdictions.
My Regulatory career has spanned more than 25 years and includes both biopharmaceuticals and high technology medical devices used for cancer treatment either in the form of targeted drug delivery or in the form of surgically invasive devices. As a Regulatory professional working for a high technology provider, I have worked with a large cross section of companies in both biopharma and medical device fields and helped these collaborators to get their products onto market in major regulatory jurisdictions.
I became a member of BIRA in 1994 and have been a member of TOPRA since its inception during which I have contributed to regulatory education by writing a number of articles in different regulatory fields. I am currently the co-chair of the Medical Devices SPIN steering committee, a position to which I have contributed since 2018.
Current or previous involvement in TOPRA activities:
I have been a member of TOPRA since its inception during which I have contributed to regulatory education by writing a number of articles in different regulatory fields. I am currently the co-chair of the Medical Devices SPIN steering committee, a position to which I have contributed since 2018.
I have also been active in TOPRA Annual Symposium in the past three years for which I have helped run networking meetings and acted as a reporter for the Regulatory Rapporteur.
Personal statement:
My Regulatory career of more than 25 years has convinced me that regulatory education is a vital part of keeping the momentum in bringing to market ever more advanced treatments and delivery systems. Having worked with both pharma and high technology medical devices and seen the ever more sophisticated use of medical devices to deliver treatments has convinced me that I am in a unique position to advocate closer understanding between the two regulatory branches, especially at a time when the regulatory landscape is being fundamentally reshaped. I will be an ardent advocate for an integrated regulatory approach for pharma and medical devices, ultimately to benefit patients.
Nomination information
Proposer: Ivan Perez Chamorro; Seconders: Janine Jameson, Robin Stephens