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Services Included PLAB1 Premium; ✔ 24/7 access to Course Tutors via WhatsApp. ✔ Live UKMLA/PLAB1 teaching sessions x 3. ✔ UKMLA/PLAB1 Complete Video Course. ✔ 10 x UKMLA/PLAB1 Mock Tests. ✔ 5K plus, the latest PLAB1/UKMLA MCQs. ✔ UKMLA/PLAB1 Complete Audio Course. ✔ 250 Digital Flashcards for rapid revision, (Clinical & Pharmacology) PLAB2 Premium; ✔ Intense 10-day face-to-face teaching programme. ✔ SimMan and Manikin teaching and practice. ✔ PLAB2 Online video course. ✔ 2 x PLAB2 Mock Exam sessions – booked when it suits you as per your exam date. ✔ 2 X UKMLA/PLAB2 Audio courses. ✔ More than 1,000 Revision Flashcards, ➢ Clinical ➢ Data Gathering, ➢ Cases & Explanation ➢ Examination & Procedures ➢ Differential Diagnosis ➢ NICE/CKS Guidelines ✔ PLAB2/UKMLA PRACTICE CASES. Key Points ✔ The most comprehensive all-in-one package for PLAB 1 Focus on both PLAB 1 knowledge and exam technique. ✔ Teaching by senior NHS clinicians including previous PLAB examiners ✔ Teaching based on UK guidelines, regularly updated Chapter-based video and audio teaching for ease of use. ✔ Multiple teaching formats for optimum preparation (live, video, audio, mocks, flashcards) ✔ Most comprehensive all-in-one package for PLAB2. ✔ Teaching by senior NHS clinicians including previous PLAB examiners. ✔ Focus on PLAB2 knowledge, technique and time management. ✔ High-quality SimMan and mannikins to learn and practice on. ✔ Non-scripted, principles-based approach. ✔ Practice-centric course – with role-play and feedback from day 1. ✔ Continuous role-plays, mock cases, practice and feedback of all key scenario types. ✔ Increase confidence in a full range of scenario types and situations. ✔ Cover areas that are often worried about eg prescribing, teaching emergency scenarios. ✔ Teaching based on UK guidelines, regularly updated. ✔ Chapter-based video and audio teaching for ease of use. ✔ Ongoing support after the academy concludes, up to exam day. ✔ All material is available for 12 months, with no limits to use at this time.

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.

An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.

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This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.

The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.