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Clinical Trials

Our courses on clinical trials cover the design, set-up, monitoring and audit/inspection of trials. We offer modules providing extensive training for clinical research associates and other staff of pharma/biotech or contract research organisations involved in clinical development. We also offer modules of value both to such staff and to clinical investigators. At a time of upheaval in the legislation on clinical research, our continually updated courses provide an essential guide to requirements and best practice.

Drug Safety and Pharmacovigilance

Our courses on drug safety and pharmacovigilance provide distinctive, high-quality presentation of crucial aspects of this vitally important field, which is the focus of ever more stringent regulation. The modules offer essential training for medical, safety, pharmacovigilance, and clinical research staff of pharma/biotech companies and contract research organisations; healthcare professionals and regulatory authority staff will also find them valuable. 

Good Manufacturing Practice

Our courses on Good Manufacturing Practice (GMP) provide a comprehensive programme of essential training for medicinal products manufacturing personnel. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company must receive initial and ongoing training in the theory and practice of GMP to comply with legal and regulatory requirements. Our modules GMP01, GMP02 and GMP03 provide ideal induction and refresher courses for all such personnel. Other modules provide training focused on warehouse, processing, or packaging staff.

Good Practices for Regulated Laboratories

Laboratories subject to inspection by regulatory authorities need to comply with international standards, regulatory guidance, and legal requirements as applicable. Such laboratories include those that carry out nonclinical studies and those performing quality control testing of products and materials in the manufacture of medicines. The former need to comply with Good Laboratory Practice (GLP); the latter need to meet the requirements of those aspects of Good Manufacturing Practice that we call Good Quality Control Laboratory Practice (GQCLP).

Our courses on GLP and GQCLP provide essential learning for all personnel of analytical laboratories, especially those working in test facilities undertaking nonclinical studies or in quality control of medicinal products.

Medical Devices

Our introductory course on medical devices provides an introduction to the basics of their regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.
Our module explains what medical devices are and gives examples of the various types. It outlines the principles of their regulation and the criteria for placing them on the market, and it identifies major players in regulation worldwide.

It then outlines prominent characteristics of the regulation of medical devices in the USA and in Europe. The module is up to date with the current upheaval in European Union legislation on medical devices.

Information and Communication Technology

Our course on US Regulation 21CFR11 explains what needs to be done to ensure that computer systems in environments regulated by the Food and Drug Administration (FDA) comply with the regulation.Our module clarifies the complicated picture of regulatory requirements and enforcement discretion applying to computer systems operated by companies that market or intend to apply for approval to market drugs or medical devices in the USA and by suppliers to those companies.

Pharmacokinetics and Pharmacodynamics

Our courses on pharmacokinetic and pharmacodynamic studies provide a thorough grounding in this field of fundamental importance in the development and registration of medicinal products.
Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug.

Our first module describes the role of in-vivo PK and PD studies in a drug development programme, sets out the uses to which the findings can be put, and discusses their implications for clinical development and application for marketing approval.
The other module extends the learner’s understanding of PK and PD studies from the basics described in PKPD01. It provides detail on a variety of aspects of such studies: design, sampling, data analysis, research in special populations, and bioequivalence testing.

Regulatory Affairs & Compliance

Our courses on regulatory affairs and compliance cover the main submissions required for the development and marketing of medicinal products in Europe and the USA. These include applications for approval to conduct clinical trials, to be granted orphan product status, to market new or generic products, and to make post-marketing changes. Whether they are introductory courses for entry-level regulatory affairs and for support staff, or they are more advanced courses for more experienced staff, they provide both a training and a reference tool that is continually updated in response to developments in regulatory requirements.

Sales and Marketing

The medicines and healthcare products industry has suffered massive monetary penalties imposed for breaches of legal and regulatory requirements on the marketing of products. Our courses on sales and marketing will help you to avoid such damaging sanctions. Our suite of courses deals with advertising and promotion of prescription drugs, and with interactions with healthcare professionals, in the USA

Validation

Our courses on validation provide essential training for manufacturing personnel in the medicines and healthcare products industries.

Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. Our suite of courses provides an introduction to validation, and practical advice on equipment commissioning and qualification, cleaning validation, and computer systems validation.

Micro Courses

These courses are perfect for students looking to focus on a particular element, or looking to revise an important subject matter. There are no CPD points for these bite-sized learning modules – if CPD accreditation is a requirement, please browse our full courses.
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