International Medical Device Clinical Investigations: A Practical Approach

Book International Medical Device Clinical Investigations A Practical Approach 1999
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Monitoring clinical trials: a practical guide

Delegates will learn how to apply project planning principles to monitoring to improve efficiency. Performing clinical trials is a complicated business, bound by regulations and good clinical practice, with the overriding concern of protecting the safety and welfare of study subjects. SOPs are critical tools in successful business operations for all those involved in doing clinical trials, including investigative sites, sponsors and IRBs.

They are essential for standardizing processes, for ensuring that regulatory and organizational policy requirements are met, for training new personnel and for managing workload.

This course will provide a practical insight into SOPs and equip participants with the knowledge and skills needed to write, manage and utilise SOPs within their organisations. Delegates will explore the principles of GCP and understand the need for, the function of and the importance of SOPs, the process of authorisation, training and implementation. The course will define the topics that require SOPs, explain the importance of flow diagrams and describe how to write and SOPs.

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This course is an introduction to the knowledge, skills and competencies that a line manager requires for performance management in the clinical research environment. Become a member! This course is now fully booked. It is recommended that delegates have a minimum of two years of monitoring experience. ISO does not apply to in vitro diagnostic medical devices.

This practical course provides delegates with basic project management techniques that can be applied to clinical trial project management. Learning is through a combination of trainer input, discussion groups and exercises. There will be a workshop where delegates will develop a plan for tracking and managing a clinical trial case study. Delegates will receive a comprehensive course workbook. Vendor Oversight is currently a hot topic as sponsors and vendors aim to get to grips with what is really required. As a vendor you want to get on with the outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company.

What is required to compliantly and efficiently implement vendor oversight?

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What are the risks and challenges of not getting this right from the beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees. This practical course defines the role of the clinical research monitor and explains the interaction with others in key roles as part of the clinical trial process as well as exploring the more complex aspects of clinical trial monitoring. Guidance will be given on best practices for selecting investigators, conducting monitoring visits and safety reporting.

Delegates will explore strategies for dealing with common clinical trial management issues and how to adopt a preventative approach to handling monitoring issues. The course uses a blend of trainer input, exercises and delegate interaction.

Clinical Trial Administrators are at the heart of any project team and play an essential role in the clinical trial process. This course gives an in-depth look into some of the aspects of clinical trials. It aims to give an understanding of the history and evolution of clinical research. Delegates will be guided through the essential documents required at each stage of the clinical trial process and their respective functions, an outline of the key roles and functions, and explores how the role of the CTA fits into the clinical trial process.

Clinical trial

The course also gives further insight into the EU legislation governing trials, ethics committees, audits and inspections, using and creating SOPs, auditing and archiving. Reporting any matter requiring a re-examination of the benefit-risk assessment of the investigational medicinal product within 15 days of becoming known. Manufacturing 8. What is the authorisation process for manufacturing medicinal products?

Application Manufacturing authorisation is required for the commercial or professional production of medicinal products and active ingredients for biologicals section 13, Medicinal Products Act. This applies to any company involved in manufacturing medicinal products, irrespective of whether it also holds the marketing authorisation or markets the medicinal product under its name.

Medical Device GCP: A Practical Summary

Even contract manufacturers carrying out production steps on behalf of a pharmaceutical enterprise require a manufacturing authorisation. Manufacturing authorisation is also required to manufacture medicinal products that are not authorised, for example medicinal products used in a clinical trial investigational medicinal products or not subject to authorisation.

The main focus is on the suitability of the rooms and equipment, the suitability of the responsible persons, and compliance of production methods and testing with the current state of science and technology section 14, Medicinal Products Act. The manufacturer will receive the manufacturing authorisation it has applied for unless one of the grounds for refusal listed in section 14 1 of the Medicinal Products Act is given.

Restrictions on foreign applicants The legal requirements apply equally to foreign and domestic applicants. Key stages and timing Applications for manufacturing authorisations must be filed before the start of the manufacturing process. In most cases, the public authority inspects the premises before granting the authorisation.

International Medical Device Clinical Investigations : A Practical Approach, Second Edition

The competent authority must decide an application within three months section 17, Medicinal Products Act. This time limit can be interrupted if the authority asks the applicant to remedy defects in the application. Fees The competent authorities fix the fees according to the legal framework for administrative fees.

They vary between the federal states and are fixed on a case-by-case basis. Period of authorisation and renewals The competent authorities usually grant unlimited authorisations. However, the authorisation can be revoked in case of non-compliance with the legal requirements. Further, under the sunset clause regulation, authorisations can be revoked in certain circumstances. This happens when a pharmaceutical company does not use the authorisation for a period of three years, that is, does not place the medicinal product on the market. Monitoring compliance and imposing penalties Enterprises and facilities in which medicinal products are manufactured, tested, stored, packaged or placed on the market, or in which any other form of trade with them takes place, are subject to supervision by the competent authority section 64, Medicinal Products Act.

The same applies to enterprises and facilities that develop medicinal products, subject them to clinical trials, residual tests or acquire or administer medicinal products. Enter and inspect during normal business hours properties, office premises, operating rooms and transport facilities. Review documentation on the development and manufacture of the medicinal products. Demand all necessary information on the company's operations. In particular, monitoring is carried out through site visits and trials scheduled on a regular basis, generally every two years.

The frequency, intensity, nature and duration of the corresponding measures depend on the circumstances of each case. The competent authorities issue necessary directives to rectify any identified infringements and prevent future infringements section 69 1 , Medicinal Products Act. They can, in particular, prohibit the marketing of medicinal products or active substances, order their recall from the market, and seize them if certain conditions are met. The competent authorities cannot impose fines or criminal penalties. Marketing Authorisation and abridged procedure.

What is the authorisation process for marketing medicinal products?

Application There are three different types of marketing authorisation:. A national marketing authorisation, issued through the national procedure by the Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich-Institute, depending on the product. A mutually recognised marketing authorisation, issued through the mutual recognition or decentralised procedure.

A community marketing authorisation for the EU, evaluated through the centralised procedure. This is mandatory for, for example, orphan drugs, advance therapy medicinal products, monoclonal antibodies and medicinal products with new effective agents to treat for example, AIDS, cancer and viral diseases. Authorisation conditions The competent authority examines the efficacy, safety and adequate pharmaceutical quality of the medicinal product. An authorisation is only granted for indications for which efficacy and safety have been shown. The appropriate pharmaceutical quality must be proven by tests in accordance with the legal requirements.

In the overall assessment, the benefits must outweigh the risks.

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The substantive requirements for the application documents are set out in sections 22 to 24 of the Medicinal Products Act and the Code for Human Medicines Directive. Depending on the chosen procedure, the scope of the documents varies. The following must be submitted in relation to the medical product:.

  1. New medical device regulations: the regulator’s view;
  2. Regulatory overview;
  3. Monitoring clinical trials: a practical guide.
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The application. Results of examinations on pharmaceutical quality, therapeutic efficacy and safety, and appropriate expert opinions. Professional information, texts for labelling and information on package sizes. An assessment of the readability of the summary of product characteristics. A description of the pharmacovigilance system and the risk management system.

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An environmental toxicological assessment. Key stages and timing The key stages and timing vary in the different procedures. For the national procedure, the applicant has the right to be granted an authorisation if the legal requirements are met, within seven months of the application section 27, Medicinal Products Act. The procedure can be expedited in certain circumstances see Question Period of authorisation and renewals The first marketing authorisation is usually valid for five years from the date of notification of the decision of the Federal Institute for Drugs and Medical Devices.

Market authorisations are renewable on application by the marketing authorisation holder. Monitoring compliance and penalties Section 30 of the Medicinal Products Act contains special provisions on the general provisions of the Administrative Procedure Act Verwaltungsverfahrensgesetz VwVfG , which regulates the revocation and withdrawal of administrative acts. In case of a breach of the regulations, the regulatory authorities can withdraw, revoke and suspend a marketing authorisation.

These are administrative acts that can be challenged by an opposition and an annulment action. Such appeals have suspensive effect, unless the authority has declared the administrative act to be immediately enforceable, which is often the case. Intentionally placing a medicinal product on the market which is no longer marketable is a criminal offence under section 96 7 of the Medicinal Products Act.

They require co-ordination between the competent authorities of the individual member states in which the medicinal product is authorised, with the involvement of the EMA. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

Chapters 10 and 11 of the Medicinal Products Act contain essential provisions on pharmacovigilance.