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PRICING AND DISCOUNTS
Purchase | Discount |
---|---|
1 course | 0% |
2 courses | 5% |
3 courses | 10% |
4 courses | 15% |
5 courses | 20% |
more(each) | 25% |
Featured Products
Good Practices (GxP) in Drug Development and Manufacturing
£29.00 £25.00 exc. VAT
Clinical Trials
How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive
£149.00 £99.00 exc. VAT
An Introduction to Clinical Trial Preparation and Design
£149.00 £99.00 exc. VAT
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
£98.00 £75.00 exc. VAT
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
£149.00 £99.00 exc. VAT
How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
£95.00 £75.00 exc. VAT
How to Conduct Clinical Research Under the EU Clinical Trials Regulation
£49.00 £39.00 exc. VAT
Clinical Trial Safety Reporting Requirements in the EU and USA
£95.00 £75.00 exc. VAT
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
Good Practices (GxP) in Drug Development and Manufacturing
£29.00 £25.00 exc. VAT
An Introduction to Good Manufacturing Practice for Medicinal Products
£74.00 exc. VAT
Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture
£39.00 exc. VAT
Good Laboratory Practice
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
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures
£74.00 £49.00 exc. VAT
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.
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
£74.00 £49.00 exc. VAT
Regulatory Affairs & Compliance
Essentials of EU and US Regulatory Affairs for Human Medicinal Products
£99.00 £79.00 exc. VAT
Preparing Submissions in the Common Technical Document (CTD) Format
£74.00 exc. VAT
The New Drug Application (NDA) for Marketing Approval in the USA
£129.00 £89.00 exc. VAT
Registration of Medicinal Products Based on Monoclonal Antibodies
£74.00 £59.00 exc. VAT
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA
£25.00 exc. VAT
How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive
£149.00 £99.00 exc. VAT
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
£149.00 £99.00 exc. VAT
How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
£95.00 £75.00 exc. VAT
How to Conduct Clinical Research Under the EU Clinical Trials Regulation
£49.00 £39.00 exc. VAT
Clinical Trial Safety Reporting Requirements in the EU and USA
£95.00 £75.00 exc. VAT
The Biologics License Application (BLA) for Marketing Approval in the USA
£99.00 £89.00 exc. VAT
The 505(b)(2) Application for Marketing Approval in the USA
£59.00 £39.00 exc. VAT
Sales and Marketing
Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA
£90.00 £70.00 exc. VAT
Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA
£95.00 £75.00 exc. VAT
Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA
£90.00 £60.00 exc. VAT
Marketing of Prescription Drugs in the USA – Interactions with Healthcare Professionals
£95.00 £75.00 exc. VAT
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.