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ONLINE TRAINING: How to write a Clinical Evaluation Report from MDR Perspective

Date

25-29 June, 1 July 2020

Location

Online

Language

English

ONLINE TRAINING: How to write a Clinical Evaluation Report from MDR Perspective

The clinical evaluation report (CER) is an important part of the Technical File/ Design Dossier for a medical device. The medical writer conducts the literature review and compiles the CER with input from design engineers, regulatory specialists, safety scientists and quality experts. The aim of this online training series is to better understand what is involved in writing a CER to Medical Device Regulation (MDR) 2017/745 standards. The online training will focus on the increased requirements of MDR and will cover the clinical evaluation process, literature review and post-market surveillance (PMS) and benefit-risk assessment.

The online training will be divided into 3 x 2-hour modules spread over 1 week

MODULE 1: Clinical Evaluation Process

  • Introduction and webinar overview
  • Medical device directives, guidelines and regulations
  • ISO 14155-3 guideline
  • MEDDEV 2.7/1 rev. 4 (2016) guideline
  • Medical Device Regulation (MDR) 2017/745
  • Medical Device Classification
  • Clinical Evaluation Plan
  • Clinical Evaluation Process
  • Clinical Evaluation Report


MODULE 2: Literature Review Part of CER

  • Literature Review Protocol
  • Literature Searches
  • Current Knowledge / State of the Art
  • Clinical Literature
  • Literature Appraisal
  • Data Extraction
  • Cliniical Literature Analysis


MODULE 3: PMS and Benefit-Risk Part of CER

  • PMS Activities: MDR and MEDDEV 2.12/1 rev.8
  • Periodic Safety Update Reports
  • Post-market clinical follow-up: MDR and MEDDEV 2.12/2 rev. 2
  • Risk Assessment
  • Benefit-Risk Assessment

Course language

The course will be in English

Gillian  Pritchard
Gillian Pritchard Director at Sylexis Ltd.

Gillian is a pharmaceutical physician and regulatory medical writer with over 30 years’ clinical and industry experience providing regulatory writing services for pharmaceutical and medical device clients. Gillian has broad pharmaceutical and medical devices experience across a wide range of therapeutic areas, e.g. cardiology, orthopaedics, clinical pharmacology, ophthalmology, diabetes and gynaecology. Over the years she has written numerous clinical study reports, clinical evaluation reports, clinical summaries and overviews, and various clinical trial documents. Gillian trained in medicine and was a research physician in academia and phase I-II contract research; a clinical project manager for phase III trials with Pfizer GRD; and also with a pharmaceutical and medical devices consultancy. She is a member of the Royal College of Physicians and Faculty of Pharmaceutical Medicine, has an MBA and an MSc in Clinical Pharmacology. Gillian is an active member of the European Medical Writers Association (EMWA) where she gives workshops on literature reviews, transferable skills in pharmaceutical and medical device writing, drug safety and ICH-GCP. She is a member of EMWA’s medical devices special interest group.

The online training will be of interest to anyone involved with the clinical evaluation process and who contributes to the CER:

  • Clinical Department managers
  • Regulatory Affairs managers
  • Marketing staff
  • CROs


Participant experience

Experience of writing or contributing to a CER and awareness of the MDR 2017/745 would be useful.

The online training format will be a slide presentation with the opportunity to ask questions and respond to audience polls during the session.

Online interactive training

Online training - 3 modules

June 25th, 2020             2:30 – 4:30 pm CEST
June 29th, 2020             2:30 – 4:30 pm CEST
July 1st, 2020                 2:30 – 4:30 pm CEST


After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Certificate of attendance

Early Bird: € 610,00* (until 4 June 2020)

Ordinary: € 685,00*

Freelance - Academy - Public Administration**: € 366,00*


*
for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

685.00 €

Early Bird

Thursday, June 4, 2020

610.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

3 modules lasting 2 hours

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Have a better understanding of how to write an MDR-compliant CER

Participants' Feedbacks

very effective training with exercises

Very practical and constructive - readily helpful

Practical and clear explanations

International and multidisciplinary profile of participants, which enriches the training

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ONLINE TRAINING: How to write a Clinical Evaluation Report from MDR Perspective

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161), as the data controller, will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for, for the management of participation in the course, for sending the newsletter, and for dissemination purposes. You can read the complete information, including your rights and how to exercise them, following this link.