20 FDA courses

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.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

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.

This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.

This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

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.

FOUR DAY ATTENDENCE AND TRAINING GUIDELINE: DAY ONE AND TWO - INTRODUCTION TO DERMAL FILLERS Day one Arrive and coffees (10.00) Registration, introduction and expectations (10.00-10.15) Structure of the training (10.15-10.30) Break (10.30-11.00) Lectures and interactive workshops / simulation (11.00 - 1230pm) Health and safety in the workplace Sharps injury and disposal The consultation process and prescriptions LUNCH (1300-1730) with a coffee break Basic life support Anaphylaxis - recognition and management Emergency kits - what it should contain and how to buy one Your doctors on call - how to contact our on call doctors for emergency advice How to use Hyalase safely - when to use it / recognise mechanism of action, how prescription in an emergency works and how to give the hyalase Practical and to include demonstration of Hyalase injection Our added benefits services for safety and convenience Day two Arrive and coffees (10.00) introduction and expectations (10.00-10.30) Structure of the training (10.30-11.00) Formal written examination covering key areas of THEORY for Dermal Filler injections: Anatomy, Physiology, Products and Complications. This will highlight early on if any important areas need to be covered in more detail for the students (11.00 - 1200) - Break for lunch - Practical session commences - (12.30 - 1800) - and in total on average we have scope for one model per 30 minutes on both of the Dermal filler days, so that’s a potential for 10 in total for a class size of maximum 4, which will give good hands on experience, as the way we train is to allow several people the opportunity to be involved with each patient - e.g. splitting into the phases of treatment, which allows the trainees to understand the concept of the treatment process. That would be - consultation, consent, marking up, readying equipment, performing the injection, providing advice and aftercare. DAY THREE AND FOUR BOTOX FOUNDATION COURSE Day three Arrive and coffees (10.00) introduction and expectations (10.00 – 10.30) Structure of the training (10.30 – 11.00) Formal written examination covering key areas of THEORY for Botox Application: Anatomy, Physiology, Products and Complications. This will highlight early on if any important areas need to be covered in more detail for the students (11.00 - 1200) - Break for lunch - Practical session commences - (12.30 - 1800) - and in total on average we have one model per 30 minutes on both the botox and days, so that’s a potential of 10 in total for a class size of 4, which will give good hands on experience, as the way we train is to allow several people the opportunity to be involved with each patient - e.g. splitting into the phases of treatment, which allows the trainees to understand the concept of the treatment process. That would be - consultation, consent, marking up, readying equipment, performing the injection, providing advice and aftercare. Day four Observed Treatment Process Examination The participants will be tested on the following key facets of safe practical care: Consultation process - rapport and understanding what the client wants Safe consent Marking and photographs Technical skill of injection Atercare provision and safety netting (eg if this happens do this / call me) 1 model will be provided for Botulinum (3 area) treatment and 1 - 2 clients for filler to ensure that each of the key anatomical areas covered are observed. Morning = Botulinum (0900 - 1230) Afternoon = Botulinum and Option Dermal fillers (1330 - 1630) Conclusion Candidates given session and refreshments and discussion regarding Case Studies and further support. (1700 - 1800)

Official BRCGS Product Safety Management course: HARPC Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.