ComplianceOnline

How to write a Clinical Evaluation

Instructor: Rebecca Kemble
Product ID: 705592
  • Duration: 90 Min
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Read Frequently Asked Questions

The course is designed to review critical elements of the new regulations and is suitable for for clinical, regulatory and quality leaders. The course is suitable to anyone who is new to Medical Devices, in addition to those who would like to further their working knowledge of current requirements.

Why Should You Attend:

The Medical Device Regulation (MDR), which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) will come into effect in May 2020. The new MDR requires significant changes to the clinical evidence that Manufacturers must document, including the information presented in the Clinical Evaluation Report. This course will discuss the requirements that manufacturers of medical devices must follow in order to comply with the Regulation and to be prepared for the increased scrutiny by the Notified Body.

The aim of the course is to help you develop a greater understanding of how to prepare a Clinical Evaluation Report. The MDR and meddev 2.7.1 rev 4 will be discussed to support Manufacturer’s compliance with EU requirements.

Areas Covered in the Webinar:

  • Updates on EU Regulations and their impact on CERs (Clinical Evaluation Reports)
  • Overview to preparation of the Clinical Evaluation Report – the 5 key stages
  • Sources of clinical data – clinical literature review
  • How to assess and analyse the clinical data to meet the new expectations
  • Conformity with the essential requirement Meddev 2.7.1 rev 4

Who Will Benefit:

  • Quality managers
  • Regulatory affairs
  • Manufacturers
  • Clinical managers
  • Product development managers
  • Project managers
Instructor Profile:
Rebecca Kemble

Rebecca Kemble
Freelance Consultant, Acclaim Biomedical Consulting Ltd

Rebecca Kemble is an experienced senior Clinical Research Professional and has worked for over 10 years, with a leading global Orthopaedic Medical Device manufacturer. During this time gained significant experience in International Post Market Clinical Follow-up and Regulatory Studies. During this time she was a Project Manager for a number of studies;; focusing on study design, recruitment and selection, study conduct, data analysis, writing reports, and liaison with Investigators/Surgeons.

More recently Rebecca has worked for a Clinical Research Organisation (CRO) covering a wide variety of therapeutic areas including Oncology, CVD, COPD, Alzheimer’s disease, Rheumatoid Arthritis, Epilepsy, Multiple Sclerosis, and Cystic Fibrosis.

Rebecca gained a PhD in 2010 which investigated the impact of antioxidants on intestinal cancer.

Follow us :
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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