Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course (May 11-12, 2023)

DUBLIN, April 18, 2023 /PRNewswire/ -- The "Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course" conference has been added to  ResearchAndMarkets.com's offering.

It is often the case that HR pick up some of the responsibility for health and safety within a business.

In many businesses there simply aren't the resources to have specialist teams for matters like H&S. Even in organisations with H&S support, HR are often required to take responsibility for a wide range of H&S matters from an employee relations perspective. But, without knowledge and training, how can HR and other non-specialist H&S people ensure they minimise the risks to themselves, the employees and the organisation?

This course has been designed to give the HR professional the essential information they need to understand what is required of them. It will provide practical guidance on what their organisation needs in place, and give them the knowledge and confidence to handle H&S scenarios.

Benefits of attending

• Understand the implications of the health & safety responsibility from an HR perspective
• Navigate health & safety management from a practical viewpoint
• Identify some common risk areas in your business
• Get to grips with common scenarios and what they mean for your business
• Learn about the process of investigating and managing incidents when they occur

The speaker, an HR specialist, providing companies with training and support particularly in areas linked to safety investigations, will use case studies and real-world examples to help bring the subject to life, ensuring delegates gain a full understanding of this important area.

Who Should Attend:

This webinar has been specifically designed for all HR professionals with health and safety responsibilities.

The topics included will also be of relevance to others that have H&S responsibilities within their business.

Agenda:

Introduction to H&S Essentials

• Why HR are drawn into the H&S world?
• The key risks HR need to consider regarding H&S
• Overview of key offences and penalties
• Defining Hazards v Risks

The H&S essentials you need to have in place

• Ensuring you are aware of what your organisation needs in place from an H&S perspective, covering everything from:
• Policy and Documentation
• Day to day H&S management
• HR-owned support - with Employee Assistance Programmes and incident reporting

Investigation of incidents

• Why you should investigate H&S matters
• What process should you follow?

Common scenarios to consider

• A review of some common H&S scenarios that HR professionals come across
• A discussion on best practices in dealing with those scenarios

Summary and final questions

Key Topics Covered:

Day 1

What is a Clinical Evaluation?

• Explanation of the terminology used in clinical evaluations
• Overview of a Clinical evaluation
• The importance of clinical evidence in medical device development

Why and When is it Necessary to Conduct a Clinical Evaluation?

• Where does clinical evaluation sit within the medical device process?
• Why is clinical evidence important?
• Who are the stakeholders in the process?

Who and What is Involved in the Clinical Evaluation Process?

• Overview of each step
• Use of equivalent products

Workshop: Bringing It Together

• An interactive exercise on what has been learnt so far

What Regulations Govern Clinical Evaluations and What Guidance Documents Should Clinical Evaluations Be Conducted To?

• An in-depth review of the available regulatory and guidance documents which can be utilised during the process and how to interpret these

Day 2

Documentation Necessary for Conducting a Clinical Evaluation

• The clinical evaluation plan

The Literature Review Process

• Selecting databases and conducting searches
• How to source data and review it
• How to clarify the question on which you need to find literature, including devising the most comprehensive literature search strategy and selecting keywords

The Clinical Evaluation Report (CER)

• What is it and what is included?
• Who should write it?
• How to write it

What is State of the Art and How to Conduct a Risk-Benefit Assessment of the Data?

• Performance and safety analysis
• State-of-the-art analysis
• Risk-benefit analysis

Impact of the Medical Device Regulations (MDR)

Speakers:

Kate Marston
Mast People Support

Kate Marston is a former Detective Sergeant from the Metropolitan Police who served on the Specialist Crime Directorate specialising in investigating firearms offences. On leaving the Metropolitan Police she led the international investigations function of a FTSE 100 luxury fashion brand. Kate founded Mast People Support in 2020 which offers investigations, HR and ethics support to organisations.

Kate is CIPD accredited and is in a fairly unique position when it comes to the support she can offer to organisations. She has a broad wealth of experience in law enforcement, retail, manufacturing, supply chain and corporate environments. This helps her provide HR support specifically in areas linked to investigations, grievances and disciplinaries. Kate is an accredited member of HR Independents; and is on the Advisory Panel of the Association of Corporate Investigators providing subject matter expertise on HR investigations and training

For more information about this conference visit https://www.researchandmarkets.com/r/gzjl0h

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