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Qmed Consulting Newsletter / September 2017


Complimentary FDA Webinar – September 22, 2017 @ 2pm CET

Be sure not to miss this highly informative webinar on Friday, September 22, 2017. Places are limited so please register today.

FDA webinar
Complimentary FDA Webinar – September 22, 2017 @ 2pm CET
This webinar will cover how FDA’s regulations, processes and recommendations for clinical studies of medical devices in the US (whether they are for 510(k)s or PMAs), including significant and nonsignificant risk studies, early feasibility, feasibility and pivotal studies, use of clinical data from outside the US, and pre-submissions. There will also be ample time for questions after the presentation.

Please register for our event here:

The webinar will be delivered by Dr. Elisa Harvey who is a Principal Consultant for our US partner Cardiomed.

Profile for Dr Elisa Harvey
Dr. Harvey is a Principal Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. Dr. Harvey brings extensive scientific and regulatory experience to assist at every step of the device development plan from early animal testing to clinical trial planning and regulatory submission strategy.
Qmed Study Nurse Training Day – November 10, 2017
Qmed will be hosting our annual study nurse training at Medicinsk Museion, Københavns Universitet, Bredgade 62,1310 Kbh.K on November 10, 2017.

This course will cover audit findings with regard to GDP and patient information. We will also have an interactive session to consolidate the learning from this course.

We will also have a guest speaker who will discuss the Health Act (obtaining consent), access to information from other hospitals and data retention. Please register for this event by clicking on the link below:

New People at Qmed Consulting
Petra Leppimäki - Regulatory Affairs and Quality Assurance Senior Principal Advisor
Petra finished her PhD in biochemistry in 2002. Since then she has been working within the pharmaceutical and medical device industries and in CROs. During that period she has gathered hands-on experience in GXP regulated R&D and production processes, including for example method and process development and validations and technology transfer. She also has extensive experience in technical writing, quality documentation, regulatory requirements, as well as, development and maintenance of quality management systems. She is fluent in Swedish, Finnish and English.

Susan Buus Jensen - Senior CRA
Susan Buus Jensen comes to Qmed with over 25 years of clinical trial experience. She started her career as an intensive care nurse and then moved to clinical research, working for a number of different manufacturers and CROs. Susan is based in our Danish office in Koege and works as a lead CRA. She has experience with both drug and device trials involving a wide range of products in areas including cardiology, oncology, endocrinology, gastroenterology and neurology.

Helle Bang - CRA
Helle Bang has worked a number of years at the Copenhagen University Hospital Rigshospitalet in the heart centre, managing a team of nurses and also acting as research nurse for a number of clinical trials. She has also worked for a year as a product specialist for a large medical device company. Helle Bang now joins Qmed as a clinical research associate.

Helen Schaap - Accountant
Helen has joined Qmed in August 2017. Due to her more than 20 years of work as accountant and financial controller, she has a broad experience and competence within bookkeeping and financial matters. Her access to work is very perfectionistic, structured and detailed oriented. She has experience with small as well as large companies within the private sector.

Sara Levi Hemmingsen - CTA
Sara will start as Clinical Trial Assistant on 1. October. Sara is a Registered Nurse and recently graduated as MSc in Health Science.

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