DPM Training | Module 3: Medicines Regulation

Start date: Thursday 13 May 2021
End date: Friday 14 May 2021 09:30-17:00 (6 hrs screen time per day)

During this training programme the syllabus of Pharmaceutical Medicine Speciality Training  is taught with a focus on the areas most relevant to the Diploma in Pharmaceutical Medicine exam.

This programme is designed for anyone who wishes to improve their knowledge in a specific area, as well as those preparing to sit the exam.

Training is delivered via Zoom, with regular screen breaks scheduled in throughout the day and a 1 hour lunch break.

FPM logo and "DPM Training Programme"

This module covers the following topics:

  • General Principles of Medicines Regulation, ICH, GMP, GCP & GLP
  • Clinical Trials Regulations – IND, CTA, EU Directives, Ethics & Ethics Committees, Fraud & Misconduct
  • Licensing – MAA, Abridged Applications
  • Common Technical Document & Overviews
  • Updating & Maintaining Licenses
  • Product Defects & Recall, Product Discontinuation
  • Unlicensed Medicines & Early Access Programmes
  • Medicines Regulation in the US & Japan
  • Orphan Drugs
  • ATMP Regulations, Medical Devices & IVDs
  • Scientific Advice/Protocol Assistance
  • Legal Reclassification (POM to OTC)

Booking for this module is now closed

About the DPM Training programme

 

The FPM training programme for the Diploma in Pharmaceutical Medicine (DPM) exam includes 9 modules.

You can book one, several or all modules as your educational training needs dictate. Modules run annually and attendance can be spread flexibly over multiple years as required.

The final 3 modules cover exam technique and focus on the Multiple Choice Question (MCQ) paper, the Single Answer Question (SAQ) paper and the Critical Appraisal Paper (CAP) of the Diploma in Pharmaceutical Medicine exam. You can find out more about the different exams here.

View the DPM Training Programme reading list.

The Modules

 

1) Drug Safety and Pharmacovigilance 11-12 March 2021

2) Non-clinical Testing & Clinical Pharmacology 15-16 April 2021

3) Medicines Regulation 13-14 May 2021

4) Statistics and Data Management 17-18 June 2021

5) Clinical Development and Discovery Medicine 8-9 July 2021

6) Healthcare Marketplace 5-6 August 2021

7) MCQ Exam Technique & Mock Exam 8 September 2021

8) SAQ Exam Technique 30 September 2021

9) Critical Appraisal Exam Technique & Mock Exam 1 October 2021

Aims

We aim to:

  • Further your understanding of key aspects of pharmaceutical medicine and the industry
  • Provide a focussed approach to learning and exam preparation
  • Give you greater confidence to sit the exam
  • Provide you with a comprehensive range of learning materials that will aid you in your professional development
  • Provide you with the knowledge needed to develop and maintain competence, ethics and integrity and the highest professional standards

Who is this course for?

  • Anyone who wishes to prepare for the Diploma in Pharmaceutical Medicine (DPM)
  • Anyone who has taken the DPM exam previously and requires refresher training
  • Anyone wishing to improve/update their knowledge in a specific module or modules
  • Anyone requiring the flexibility of a modular training programme
  • Anyone preferring a focussed, strategic approach to training and exam preparation
  • You do not need to be a Pharmaceutical Physician, have a medical degree, be enrolled in HMT/PMST or be planning to sit the Diploma in Pharmaceutical Medicine exam in order to attend.
  • Anyone taking the CPM

Booking Information

FPM will close bookings when the event sells out, and no later than 13:00 on 11 May 2021.

Queries: If you are unable to complete your booking online or you would like to be invoiced, please email training@fpm.org.uk.

Joining instructions will be emailed to attendee’s registered e-mail address, with a reminder sent on 12 May 2021.

Please note: you will need a computer and a good internet connection, pens and paper to attend this module.

A pre-course assignment will be sent out 2 weeks in advance. If you book after this date, please allow yourself time to complete the assignment before the training.

Resources included with this module

  • Pre-course assignment This will be sent to registered attendees 2 weeks beforehand. Please complete this assignment before the course begins.
  • PowerPoint slides We will also send you the powerpoint slides in advance, so that you can use them to aid your online learning.
  • Example exam questions 
  • Key readings and papers 

 

Learning materials can also be purchased separately, and these will be made available to buy online after the 14 May 2021.

Buy the online learning materials

  • Materials for each module are available after the module end date
  • A link to the online folder of materials will be sent by email the next working day after purchasing online.

CPD

If you attend this course you can use it as CPD for your appraisal. To do so you’ll need to provide:

  • evidence (certificate of attendance), and
  • reflection, specifically a couple of paragraphs on what you learnt, what effect it will have on your current practice and how it relates to Good Medical Practice.

Upload these into your portfolio and self-allocate your CPD points at 0.25 credits per 15 mins.

Refund policy

  • For cancellations up to 1 week before the start date a full refund will be given.
  • For cancellations between 1 week and 1 day before the start date a 50% refund will be given. If someone else can take your place on the module, a full refund will be provided.
  • Refunds cannot be given after the published closing date.
  • In the event of cancellation by FPM a full refund will be given.

Meet your Lead Trainer

Prof Alan Boyd is the Lead Trainer for the DPM training programme.

Professor Alan Boyd is a Fellow and immediate Past President of FPM. He was previously Chair of the Specialist Advisory Committee in Pharmaceutical Medicine at the Royal College of Physicians, United Kingdom.

In 2009 he was appointed an Honorary Professor at the College of Medical and Dental Sciences, University of Birmingham Medical School. In 2014 he was elected as a Fellow of the Royal Society of Biology, and in 2018 he was elected as a Fellow of the Royal College of Physicians, London.

Professor Boyd has also received the Outstanding Contribution Award at the 15th annual Bionow Award Ceremony in 2016. This award was given in recognition of a significant contribution to the development of medicines and the specialty of pharmaceutical medicine as an industrialist, an educator and an inspirational leader.

Alan was co-founder of the Boyds DPM training programme, which he has run successfully for over a decade. In 2020, this programme switched to an online format and was hosted by FPM. We are very pleased that were are now able to offer this programme as an FPM training course.

Professor Alan Boyd

The views, information, or opinions expressed during FPM events and training are those of the individuals involved and do not necessarily represent those of the Faculty of Pharmaceutical Medicine. We value inclusivity, equality and diversity, and work hard to promote these whenever possible in all of our activities. We welcome your comments and feedback: events@fpm.org.uk