2021-12-18 2022-05-19 , Online Online, 1.090,- € zzgl. MwSt. Jan Bart Hak https://www.forum-institut.de/seminar/22052500-clinical-evaluation-and-post-market-surveillance/referenten/22/22_05/22052500-course-clinical-evaluation-and-pms-medical-devices_hak-jan-bart.jpg Clinical Evaluation and Post-Market Surveillance

This online course provides you with sound knowledge of how to deal with the clinical evaluation (CE) and post-market surveillance (PMS) of medical devices in accordance with Medical Device Regulation (EU) 2017/ 745 (MDR) and the Medical Device Coordination Group (MDCG) guidance documents.

Your Topics
  • Requirements and the regulatory and normative basics of clinical evaluation (CE)
  • Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
  • Post-market surveillance (PMS) with reference to the Medical Device Regulation (MDR)
  • Set-up and implementation of PMS
  • Vigilance, market surveillance and post-market clinical follow-up (PMCF)
Aims and Objectives
Both clinical evaluation (CE) and post-market surveillance (PMS) are mandatory for every medical device manufacturer in Europe. This online course addresses the basics of clinical evaluation, including the content of the most important documents: the clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). Once your product has been certified, it needs to be kept under surveillance. Learn how to set up and implement post-market surveillance, vigilance and market surveillance in accordance with Regulation (EU) 2017/745 (MDR).

Our experts are open to questions and discussion, and will guide you on how to successfully comply with the complex regulations in practice.
Who should attend

This online course is intended for healthcare professionals responsible for the preparation and maintenance of clinical evaluations and/or the implementation and optimisation of PMS. Those working in the following departments will particularly benefit from the speakers’ first-hand expertise:

  • regulatory affairs and quality assurance,
  • medical affairs, clinical affairs and medical writing, and
  • product and project management.

Clinical Evaluation and Post-Market Surveillance

Clinical Evaluation and Post-Market Surveillance

The current regulations in the European Union

Benefits
  • Meet the experts!
  • The essentials in two days!
  • Online format: modern, flexible, interactive
  • We are following the IMI quality criteria

Webcode 22052500

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Referenten


Alles auf einen Blick

Termin

18. - 19.05.2022

18. - 19.05.2022

Zeitraum

1st morning: 09:00 - 13:00 CET2nd mo...

1st morning: 09:00 - 13:00 CET
2nd morning: 08:30 - 13:00 CET
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Antje Bauer
Conference Manager

+49 6221 500-655
a.bauer@forum-institut.de

Details

This online course provides you with sound knowledge of how to deal with the clinical evaluation (CE) and post-market surveillance (PMS) of medical devices in accordance with Medical Device Regulation (EU) 2017/ 745 (MDR) and the Medical Device Coordination Group (MDCG) guidance documents.

Your Topics
  • Requirements and the regulatory and normative basics of clinical evaluation (CE)
  • Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
  • Post-market surveillance (PMS) with reference to the Medical Device Regulation (MDR)
  • Set-up and implementation of PMS
  • Vigilance, market surveillance and post-market clinical follow-up (PMCF)
Aims and Objectives

Both clinical evaluation (CE) and post-market surveillance (PMS) are mandatory for every medical device manufacturer in Europe. This online course addresses the basics of clinical evaluation, including the content of the most important documents: the clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). Once your product has been certified, it needs to be kept under surveillance. Learn how to set up and implement post-market surveillance, vigilance and market surveillance in accordance with Regulation (EU) 2017/745 (MDR).

Our experts are open to questions and discussion, and will guide you on how to successfully comply with the complex regulations in practice.

Who should attend

This online course is intended for healthcare professionals responsible for the preparation and maintenance of clinical evaluations and/or the implementation and optimisation of PMS. Those working in the following departments will particularly benefit from the speakers’ first-hand expertise:

  • regulatory affairs and quality assurance,
  • medical affairs, clinical affairs and medical writing, and
  • product and project management.

Detailed programme

1st morning: 09:00 - 13:00 CET
2nd morning: 08:30 - 13:00 CET

Brief introduction: The basics
  • About the MDR
  • Clinical evidence and risk management (ISO 14971), residual risk and clinical evidence
  • Where CE is necessary and how it is embedded in the MDR

Requirements for CEs
  • Details of Regulation (EU) 2017/745 (MDR) regarding CE
  • MEDDEV 2.7/1 revision 4 and the Medical Device Coordination Group (MDCG) guidance documents
  • Expectations of the notified body or bodies

Content of the clinical evaluation plan (CEP)
  • Product description and requirements
  • Objective of the CE
  • The CEP

The clinical evaluation cycle and the clinical evaluation report (CER)
  • Identifying the data
  • Analysing the data
  • Compiling the CER
  • What to do in the event of gaps in the data?
  • Clinical strategy and clinical studies (ISO 14155)
  • Updating the CER with clinical data

Introduction to regulatory basics
  • MDR Annex III
  • What does PMS mean in terms of the MDR? (MDR Chapter 7 - Post-market surveillance, vigilance and market surveillance)
  • PMS interfaces: CE, technical file (Annexes II and III), risk management, etc.

Set-up and implementation of PMS
  • Old references: MEDDEV 2.12 and IMDRF/GHTF documents
  • How-to post-market surveillance plan
  • PMS plan: Planning, realization and implementation (data, documents, etc.
  • How-to post-market surveillance report (PMS report and PSUR)
  • What to consider now: Annex XIV Part B
  • How to implement PMS processes (how, who, what, checklists, etc.)
  • Periodic safety update report/SSCP

The PMCF
  • When is a PMCF indicated for clinical follow-up?
  • CE, CEP and CER ('close a circle') and updating
  • The benefit-risk assessment
  • Requirements for the PMCF plan and test plan of a PMCF study: plan, design, statistics, configuration, study types, proof of performance, etc.
  • Requirements for the PMCF report and PSUR

Vigilance and market surveillance
  • MDR definition of an adverse event, serious adverse event and serious incident (new definitions)
  • Timelines
  • Reports (trend reporting)
  • Reporting serious incidents and field safety corrective actions

Further information

Your benefit

After our online course you will have understood the complex relationships between clinical evaluation, PMS, PMCF, vigilance and market surveillance. You will have updated your knowledge and be able to establish appropriate processes for clinical evaluation, PMS, PMCF and market monitoring.

How does an online course work?

The Zoom webcasts are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live, using the chat function.

1. You will receive brief instructions on how to use Zoom online seminars beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Use the chat function to ask questions

The benefits of an online course

  • online seminar – live and interactive via zoom
  • Your access data and documents always accessible in your customer portal
  • Didactically and technically well-rounded concept with plenty of room for your questions.
  • Continuous support during the online seminar for optimal learning success

Questions?

The participants are warmly invited to also contribute their own experiences for a thorough exchange! Please send your topic at least 10 working days before the start of the webcasts to Antje Bauer - a.bauer@forum-institut.de.

FAQ

1.) You need a reliable Internet connection and a browser. The following Windows browsers are applicable:
- Internet Explorer 8 onwards
- Mozilla Firefox
- Google Chrome

2.) We recommend using the Zoom app to connect with your mobile device.
- You will need a headset, loudspeakers, or a telephone for audio.

3.) Can I test my equipment beforehand?
- Yes, you can check whether everything will work properly on the day of your online training.
Just click the following link to run a test: https://zoom.us/test

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