Scheduled In-house

Life Sciences Training Courses

Our life sciences training courses cover Pharmaceuticals, Medical Devices, IVDs, Biotech/Biopharma and Animal Health and have been designed to focus on regulatory affairs, clinical trials, pharmacovivilance, medical writing, latest developments, and best practices (GxP).  Our portfolio of events is extensive and provides training from basic to advanced levels in a variety of formats.  

The pandemic created numerous challenges across all areas of business worldwide and companies had to respond and adapt very quickly. Now, as the healthcare sector emerges stronger and with renewed strategy, life science companies continue to focus on key areas for development, explore the use of emerging technologies, and seek opportunities to harness collaborations and build resilience. 

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  • Next: on request

Registration of Animal Feed Additives in the EU

Bespoke

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

  • 12 CPD hours Focused
  • Next: on request

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

Bespoke

This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.

  • 6 CPD hours
  • Presented by Nancy Consterdine
  • Next: on request

Update - Latest Position on the New UK Clinical Trial Proposals

Bespoke

‘Better regulation…for better trials…for better health’ The Medicines and Healthcare products Regulatory Agency (MHRA) have set far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. This webinar will bring you up-to-date with the current position regarding the proposals and the potential implications and opportunities for the industry.

  • 1.5 CPD hours High impact
  • Presented by Dr David Jefferys
  • Next: 5 Dec 2023 Live online

Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers

New for 2023

Live online

The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.

  • 3 CPD hours High impact
  • Presented by Annette Callaghan
  • Next: 11-15 Dec 2023 Live online
  • Also: 20-22 Mar 2024 Live online
  • Also: 5-7 Jun 2024 Classroom
  • + 2 more

Advanced Pharmacovigilance

Live online, Classroom

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 9-10 Oct 2023 Live online
  • Also: 1-2 Feb 2024 Live online
  • Also: 4-7 Jun 2024 Live online
  • Also: 7-8 Oct 2024 Live online

Advanced Regulatory Affairs for Medical Devices

Live online

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • and Theresa Jeary
  • Next: 18-19 Oct 2023 Live online
  • Also: 22-25 Jan 2024 Live online
  • Also: 16-17 Apr 2024 Live online
  • + 2 more

Advanced Veterinary Pharmacovigilance

Live online

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

  • 12 CPD hours Focused
  • Presented by Declan O'Rourke
  • Next: 17-20 Jun 2024 Classroom

The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA

Summer school

Classroom

This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

  • 24 CPD hours Intensive
  • Presented by Andrew Hewitt
  • + 2 more
  • Next: 24 Jan 2024 Live online
  • Also: 15 May 2024 Live online
  • Also: 18 Sep 2024 Classroom

Artificial Intelligence and Machine Learning Powered Signal Management

New for 2024

Live online, Classroom

This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.

  • 6 CPD hours Focused
  • Presented by Dr Sanjeev Srivastav
  • Next: 14 Dec 2023 Live online
  • Also: 23 Apr 2024 Live online
  • Also: 18 Jul 2024 Live online
  • Also: 12 Dec 2024 Live online

Best Practice for Writing Effective SOPs

Live online

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 14-15 Mar 2024 Classroom
  • Also: 16-17 Sep 2024 Classroom

Biological Evaluation of Medical Devices

Classroom

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions

  • 12 CPD hours Focused
  • Presented by Philip Clay
  • and Rona Middlemiss
  • Next: 30-31 Oct 2023 Live online
  • Also: 5-6 Mar 2024 Live online
  • Also: 10-11 Jul 2024 Live online
  • Also: 1-2 Oct 2024 Live online

Biosimilars

Live online

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

  • 12 CPD hours Focused
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 4-8 Dec 2023 Live online

Biotechnology for the Non-Biotechnologist

Live online

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

  • 18 CPD hours Focused
  • Presented by Mardon McFarlane
  • + 6 more
  • Next: 15 Dec 2023 Live online
  • Also: 22 Apr 2024 Live online
  • Also: 19 Jul 2024 Live online
  • Also: 13 Dec 2024 Live online

CAPA (Corrective and Preventative Action)

Live online

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement, and planning and implementation in process improvements and CAPA.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 26-27 Oct 2023 Live online
  • Also: 29 Feb-1 Mar 2024 Live online
  • Also: 27-28 Jun 2024 Live online
  • Also: 17-18 Oct 2024 Live online

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2023

Live online

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 29-30 Nov 2023 Live online
  • Also: 26-29 Feb 2024 Live online
  • Also: 9-10 May 2024 Live online
  • + 2 more

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online, Classroom

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours Focused
  • Presented by Adrian Keene
  • and Janette Benaddi
  • Next: 4-5 Oct 2023 Live online
  • Also: 7-8 Feb 2024 Live online
  • Also: 19-20 Jun 2024 Live online
  • Also: 2-3 Oct 2024 Live online

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

  • 6 CPD hours Focused
  • Presented by Dr John Price
  • Next: 16-17 Nov 2023 Live online
  • Also: 25-26 Jan 2024 Live online
  • Also: 23-24 May 2024 Live online
  • Also: 19-20 Sep 2024 Live online

Clinical Quality Management Systems

Live online

A two-day course that will ensure you comply with new regulatory requirements.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 16 Feb 2024 Live online
  • Also: 10 Jun 2024 Live online
  • Also: 4 Oct 2024 Live online

Clinical Research - A Different Approach to Successful Project Delivery

New for 2024

Live online

This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.

  • 6 CPD hours
  • Presented by Roger Joby
  • Next: 26-28 Feb 2024 Live online
  • Also: 26-28 Jun 2024 Live online
  • Also: 23-25 Oct 2024 Live online

Clinical Research Project Management

Updated for 2024

Live online

The leading clinical research project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

  • 18 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 29-30 Apr 2024 Live online
  • Also: 11-12 Jul 2024 Live online
  • Also: 2-3 Dec 2024 Live online

Clinical Trial Monitoring

Live online

This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 22-23 Jan 2024 Live online
  • Also: 2-3 May 2024 Live online
  • Also: 16-17 Sep 2024 Live online

Clinical Trial Regulatory Requirements

Live online

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation one year on and a brief review of key FDA requirements.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 20 Mar 2024 Live online
  • Also: 18 Sep 2024 Live online

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

New for 2024

Live online

An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.

  • Presented by Professor John E. Harrison
  • Next: 27-28 Nov 2023 Live online
  • Also: 12-13 Mar 2024 Live online
  • Also: 2-3 Jul 2024 Live online
  • Also: 25-26 Nov 2024 Live online

The Common Technical Document

Live online

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours Focused
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 30 Nov 2023 Live online
  • Also: 14 Mar 2024 Live online
  • Also: 10 Jul 2024 Live online
  • Also: 28 Nov 2024 Live online

The Common Technical Document (CTD) Submission in the MENA Region

New for 2023

Live online

This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.

  • 6 CPD hours
  • Presented by Mohammad Fat'hy Elnadi
  • Next: 5-6 Feb 2024 Live online
  • Also: 20-21 Jun 2024 Live online
  • Also: 14-15 Oct 2024 Live online

Cosmetovigilance

Updated for 2024

Live online

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 10-11 Oct 2023 Live online
  • Also: 29-30 Jan 2024 Live online
  • Also: 25-26 Apr 2024 Live online
  • + 2 more

Cyber Security for Medical Devices

Live online, Classroom

This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

  • 12 CPD hours Focused
  • Presented by Ben Kokx
  • Next: 1 Dec 2023 Live online
  • Also: 12 Apr 2024 Live online
  • Also: 22 Jul 2024 Live online
  • Also: 6 Dec 2024 Live online

Data Integrity and Document Management

Live online

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 10 Oct 2023 Live online
  • Also: 6 Feb 2024 Live online
  • Also: 4 Jun 2024 Live online
  • Also: 8 Oct 2024 Live online

Delivery of Biologics to the Nasal Cavity

New for 2023

Live online

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

  • 3 CPD hours Focused
  • Presented by Dr Irene Rossi
  • + 3 more
  • Next: 9-12 Oct 2023 Live online
  • Also: 12-13 Feb 2024 Live online
  • Also: 25-26 Jun 2024 Live online
  • Also: 7-10 Oct 2024 Live online

Development of Combination Products: Critical Interactions

Live online

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 25-26 Jan 2024 Live online
  • Also: 9-10 May 2024 Live online
  • Also: 19-20 Sep 2024 Live online

Drug Discovery: A Step-by-Step Introduction

New for 2024

Live online

This drug discovery training course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful drug discovery project.

  • 12 CPD hours Focused
  • Presented by Dr Peter A. Lowe
  • Next: 14-15 Feb 2024 Live online
  • Also: 17-18 Oct 2024 Live online

Drug/Device and Device/Drug Combinations in the EU and USA

Live online

Practical guidance on borderline Issues and combination products

  • 12 CPD hours Focused
  • Presented by Dr David Jefferys
  • + 2 more
  • Next: 1 Feb 2024 Live online
  • Also: 28 Jun 2024 Live online
  • Also: 1 Oct 2024 Live online

Effective Technical Writing & Editing

Live online

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours Focused
  • Presented by Barbara Grossman
  • Next: 23-24 Jan 2024 Live online
  • Also: 16-17 Apr 2024 Classroom
  • Also: 16-17 Jul 2024 Live online
  • Also: 7-8 Oct 2024 Classroom

Effective Technology Transfer

Live online, Classroom

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours Focused
  • Presented by Bruce Davis
  • Next: 1 Dec 2023 Live online
  • Also: 15 Mar 2024 Live online
  • Also: 11 Jul 2024 Live online
  • Also: 29 Nov 2024 Live online

An Essential Overview of Medical Information

Live online

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 29 Jan 2024 Live online
  • Also: 16 May 2024 Live online
  • Also: 9-10 Sep 2024 Live online

An Essential Overview of Pharmacovigilance

Live online

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 10 Nov 2023 Live online
  • Also: 1 Mar 2024 Live online
  • Also: 8-9 Jul 2024 Live online
  • Also: 8 Nov 2024 Live online

An Essential Overview of the Medical Device Industry

Live online

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours Focused
  • Presented by Dr David Jefferys
  • and Theresa Jeary
  • Next: 19 Jan 2024 Live online
  • Also: 10 May 2024 Live online
  • Also: 13 Sep 2024 Live online

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 13-14 Nov 2023 Live online
  • Also: 15-16 Feb 2024 Live online
  • Also: 20-21 May 2024 Live online
  • + 2 more

EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience

Live online

This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 16-17 Oct 2023 Live online
  • Also: 12-13 Feb 2024 Live online
  • Also: 11-12 Jun 2024 Classroom
  • Also: 14-15 Oct 2024 Live online

EU Pharmaceutical Regulations & Strategy

Live online, Classroom

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 24 Jan 2024 Live online
  • Also: 22 May 2024 Live online
  • Also: 18 Sep 2024 Live online

EU Proposed Pharmaceutical Legislation Changes

New for 2024

Live online

On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation. This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.

  • 3 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 6-10 Nov 2023 Live online
  • Also: 4-8 Mar 2024 Live online
  • Also: 15-17 Jul 2024 Live online
  • Also: 4-8 Nov 2024 Live online

European Post Marketing Pharmacovigilance - Including the EMA/PRAC deliberations and Brexit implications

New for 2023

Live online

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

  • Focused
  • Presented by Dr Graeme Ladds
  • Next: 27-28 Nov 2023 Live online
  • Also: 19-22 Mar 2024 Live online
  • Also: 19-20 Jun 2024 Live online
  • + 2 more

FDA Approval Process for Medical Devices

Live online, Classroom

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours Focused
  • Presented by Dr Jonathan Hughes
  • Next: 2-3 Oct 2023 Live online
  • Also: 6-7 Feb 2024 Live online
  • Also: 12-13 Jun 2024 Live online
  • Also: 14-15 Oct 2024 Live online

The FDA Drug Approval Process

Live online

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

  • 12 CPD hours Focused
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 17 Oct 2023 Live online
  • Also: 25 Apr 2024 Live online
  • Also: 19 Jul 2024 Live online
  • Also: 2 Dec 2024 Live online

Filing eCTD Submissions

Live online

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

  • 6 CPD hours Focused
  • Presented by Mercia Lucouw
  • + 2 more
  • Next: 24 Nov 2023 Live online
  • Also: 15 Mar 2024 Live online
  • Also: 8 Jul 2024 Live online
  • Also: 22 Nov 2024 Live online

GCP and Clinical Research Update - Hot Inspection Topics

Live online

This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 7 Dec 2023 Live online

How to Advance and Accelerate Clinical Trials

New for 2023

Live online

This course has been specifically designed to review ways to accelerate the clinical trial process and will provide an excellent opportunity to discuss the opportunities available and how to implement them with an expert in the field of pharmaceutical business development.

  • 6 CPD hours
  • Presented by Graham Howieson
  • Next: 27-28 Nov 2023 Live online
  • Also: 5-6 Mar 2024 Live online
  • Also: 5-6 Jun 2024 Classroom
  • + 2 more

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Live online, Classroom

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

  • 12 CPD hours Focused
  • Presented by Richard Featherstone
  • Next: 21 Nov 2023 Live online

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

New for 2023

Live online

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

  • 3 CPD hours
  • Presented by Annette Callaghan
  • Next: 14 Dec 2023 Live online
  • Also: 24 Apr 2024 Live online
  • Also: 10 Jul 2024 Classroom
  • Also: 23 Oct 2024 Live online

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

New for 2023

Live online, Classroom

This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

  • Presented by Greg Thay
  • Next: 28 Nov 2023 Live online

An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

New for 2023

Live online

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

  • 3 CPD hours
  • Presented by Annette Callaghan
  • Next: 2 Nov 2023 Live online
  • Also: 6 Mar 2024 Live online
  • Also: 4 Jul 2024 Classroom
  • Also: 20 Nov 2024 Live online

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

New for 2023

Live online, Classroom

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

  • 6 CPD hours Focused
  • Presented by Stuart Angell
  • Next: 21-24 Nov 2023 Live online
  • Also: 19-20 Mar 2024 Live online
  • Also: 17-18 Jul 2024 Live online
  • Also: 19-22 Nov 2024 Live online

An Introduction to ISO 22716 - GMP for Cosmetic Products

New for 2023

Live online

This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik
  • Next: 30 Jan-1 Feb 2024 Live online
  • Also: 20-22 May 2024 Live online
  • Also: 25-27 Sep 2024 Classroom

An Introduction to Pharmaceutical Packaging

Live online, Classroom

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours Focused
  • Presented by Chris Penfold
  • Next: 5-6 Oct 2023 Live online
  • Also: 22-23 Apr 2024 Live online
  • Also: 24-25 Jul 2024 Live online
  • Also: 10-11 Dec 2024 Live online

An Introduction to the Design and Development of Medical Devices

Live online

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

  • 12 CPD hours Focused
  • Presented by David Howlett
  • Next: 9-10 Nov 2023 Live online
  • Also: 7-8 Mar 2024 Live online
  • Also: 24-25 Jul 2024 Live online
  • Also: 5-8 Nov 2024 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

  • 12 CPD hours Focused
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • Next: 6-8 Nov 2023 Live online
  • Also: 6-8 Feb 2024 Live online
  • Also: 15-17 May 2024 Live online
  • + 2 more

An Introduction to the Medical Device Regulation

Live online, Classroom

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours Focused
  • Presented by Janette Benaddi
  • + 2 more
  • Next: 5-8 Feb 2024 Live online
  • Also: 27-28 Jun 2024 Live online
  • Also: 2-3 Oct 2024 Live online

Introduction to Veterinary Pharmacovigilance

Live online

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*

  • 12 CPD hours Focused
  • Presented by Declan O'Rourke
  • Next: 1 Nov 2023 Live online
  • Also: 1 May 2024 Live online
  • Also: 5 Nov 2024 Live online

Managing Competence within the Medical Device Industry

New for 2023

Live online

This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.

  • 1.5 CPD hours
  • Presented by Anne Jury
  • Next: 19-20 Oct 2023 Live online
  • Also: 15-16 Jan 2024 Live online
  • Also: 18-19 Apr 2024 Live online
  • + 2 more

Managing Vendor/CRO/CMO Oversight

Live online

Optimising oversight for inspection compliance

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 9 Nov 2023 Live online
  • Also: 6 Mar 2024 Live online
  • Also: 26 Jul 2024 Live online
  • Also: 7 Nov 2024 Live online

Masterclass: Artificial Intelligence-based Medical Devices

Live online

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust and to ensure data is portable and qualitative. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

  • 6 CPD hours Focused
  • Presented by Koen Cobbaert
  • Next: 11-12 Dec 2023 Live online
  • Also: 16-19 Apr 2024 Live online
  • Also: 2-3 Jul 2024 Live online
  • Also: 9-10 Dec 2024 Live online

Medical Device Regulation in the Eurasian Union, Russia and the CIS

Live online

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

  • 12 CPD hours Focused
  • Presented by Anna Harrington-Morozova
  • Next: 5-6 Feb 2024 Live online
  • Also: 11-12 Jun 2024 Live online
  • Also: 7-10 Oct 2024 Live online

Medical Device Regulations in the Middle East and North Africa

Live online

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours Focused
  • Presented by Heba Hashem
  • and Ilona Putz
  • Next: 4-8 Dec 2023 Live online
  • Also: 10-14 Jun 2024 Classroom
  • Also: 2-6 Dec 2024 Live online

The Medical Device School - From Concept to CE Marking

Summer school

Live online, Classroom

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours Intensive
  • Presented by Adrian Keene
  • + 7 more
  • Next: 30 Nov-1 Dec 2023 Live online

Medical Device Single Audit Programme (MDSAP)

New for 2023

Live online

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours Focused
  • Presented by Nancy Consterdine
  • Next: 11-14 Dec 2023 Live online
  • Also: 22-25 Apr 2024 Classroom
  • Also: 22-25 Jul 2024 Live online
  • Also: 9-12 Dec 2024 Live online

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online, Classroom

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 24 CPD hours Focused
  • Presented by Koen Cobbaert
  • and Zuzanna Kwade
  • Next: 13-14 Nov 2023 Live online
  • Also: 18-21 Mar 2024 Live online
  • Also: 10-11 Jul 2024 Live online
  • Also: 11-12 Nov 2024 Live online

Medical Device Studies: Clinical Evidence

Live online

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours Focused
  • Presented by Adrian Keene
  • + 3 more
  • Next: 17-18 Jan 2024 Live online
  • Also: 21-22 May 2024 Live online
  • Also: 16-19 Sep 2024 Live online

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 23-24 Nov 2023 Live online
  • Also: 13-14 Mar 2024 Live online
  • Also: 1-2 Jul 2024 Live online
  • Also: 21-22 Nov 2024 Live online

Medical Writing for Medical Devices

Live online

How to produce quality regulatory documents including the clinical evaluation report (CER)

  • 12 CPD hours Focused
  • Presented by Barbara Grossman
  • and Janette Benaddi
  • Next: 26-29 Feb 2024 Live online
  • Also: 20-21 Jun 2024 Live online
  • Also: 9-10 Oct 2024 Live online

Metered Dose Inhaler (MDI) Technology

Live online

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

  • 12 CPD hours Focused
  • Presented by David Howlett
  • Next: 6 Mar 2024 Live online
  • Also: 11 Jul 2024 Live online
  • Also: 25 Nov 2024 Live online

Metrics and Earned Value in Clinical Research Projects

New for 2024

Live online

This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.

  • 3 CPD hours Masterclass
  • Presented by Roger Joby
  • Next: 1 Feb 2024 Live online

Navigating China’s API Regulations: An Essential Guide to DMF Registration

New for 2024

Live online

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

  • 1.5 CPD hours
  • Presented by Raymond Ng
  • and Helen Ye
  • Next: 28-30 Nov 2023 Live online
  • Also: 12-14 Mar 2024 Live online
  • Also: 2-4 Jul 2024 Live online
  • Also: 26-28 Nov 2024 Live online

New EU GMP Annex 1: Compliant Aseptic Operations

New for 2023

Live online

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

  • 18 CPD hours
  • Presented by Mustafa Edik
  • Next: 7 Dec 2023 Live online

Non-Conformance and Corrective Action for Medical Device Manufacturers

New for 2023

Live online

The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan
  • Next: 5-8 Feb 2024 Live online
  • Also: 18-19 Jun 2024 Live online
  • Also: 14-15 Oct 2024 Live online

Pharmaceutical Development of ATMPs

Live online

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 21-24 Nov 2023 Live online
  • Also: 7-8 Mar 2024 Live online
  • Also: 23-24 Jul 2024 Live online
  • Also: 19-22 Nov 2024 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

  • 12 CPD hours Focused
  • Presented by Makram Nehme
  • and Salma Ismail
  • Next: 7-9 Nov 2023 Live online
  • Also: 14-16 Feb 2024 Live online
  • Also: 12-14 Jun 2024 Live online
  • Also: 9-11 Oct 2024 Live online

Pharmaceutical Regulatory Affairs in Asia

Live online

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

  • 18 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer
  • Next: 12-13 Dec 2023 Live online
  • Also: 29-30 Apr 2024 Live online
  • Also: 2-3 Jul 2024 Live online
  • Also: 10-11 Dec 2024 Live online

Pharmaceutical Regulatory Affairs in China

Live online

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

  • 12 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer
  • Next: 5-6 Oct 2023 Live online
  • Also: 8-9 Feb 2024 Live online
  • Also: 24-27 Jun 2024 Live online
  • Also: 3-4 Oct 2024 Live online

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

  • 12 CPD hours Focused
  • Presented by Anna Harrington-Morozova
  • Next: 11-14 Dec 2023 Live online
  • Also: 22-23 Apr 2024 Live online
  • Also: 17-18 Jul 2024 Live online
  • Also: 9-12 Dec 2024 Live online

Pharmaceutical Regulatory Affairs in the Middle East

Live online

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

  • 12 CPD hours Focused
  • Presented by Heba Hashem
  • and Ilona Putz
  • Next: 31 Jan-2 Feb 2024 Live online
  • Also: 12-14 Jun 2024 Live online
  • Also: 9-11 Oct 2024 Live online

Pharmacovigilance

Live online

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours Focused
  • Presented by Dr Glyn Belcher
  • + 4 more
  • Next: 29-30 Nov 2023 Live online
  • Also: 1 Mar 2024 Live online
  • Also: 10 Jul 2024 Live online
  • Also: 27-28 Nov 2024 Live online

Pharmacovigilance Aspects of Licensing Agreements

Live online

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

  • 6 CPD hours Focused
  • Presented by Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 31 Jan-2 Feb 2024 Live online
  • Also: 8-10 May 2024 Live online
  • Also: 30 Sep-2 Oct 2024 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge

New for 2024

Live online

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

  • 18 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 22-25 Jan 2024 Live online
  • Also: 20-21 May 2024 Live online
  • Also: 26-27 Sep 2024 Live online

Pharmacovigilance QMS & Inspection Preparation

Live online

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 13-14 Nov 2023 Live online
  • Also: 11-12 Mar 2024 Live online
  • Also: 11-12 Nov 2024 Classroom

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

Live online, Classroom

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

  • 12 CPD hours Focused
  • Presented by Dr Callum Scott
  • and Dr Mel Munro
  • Next: 19 Jan 2024 Live online
  • Also: 17 Apr 2024 Live online
  • Also: 23 Jul 2024 Live online
  • Also: 10 Oct 2024 Live online

A Practical Guide to Producing and Maintaining the PSMF

Live online

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 5 Oct 2023 Live online
  • Also: 18 Jan 2024 Live online
  • Also: 16 Apr 2024 Live online
  • + 2 more

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 28-29 Nov 2023 Classroom
  • Also: 19-20 Mar 2024 Live online
  • Also: 26-27 Nov 2024 Classroom

Practical Implementation of GCP in Veterinary Field Studies

Live online, Classroom

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

  • 12 CPD hours Focused
  • Presented by Donna Taylor
  • and Jenny Webster
  • Next: 19-20 Oct 2023 Live online
  • Also: 13-14 Feb 2024 Live online
  • Also: 13-14 Jun 2024 Live online
  • Also: 17-18 Oct 2024 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

Live online

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 8-9 Nov 2023 Live online
  • Also: 21-22 Mar 2024 Live online
  • Also: 25-26 Jul 2024 Live online
  • Also: 6-7 Nov 2024 Live online

Pre-Filled Syringes: End-to-End Processing

Live online

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

  • 6 CPD hours Focused
  • Presented by Andreas Rothmund
  • and Dr. Dale Charlton
  • Next: 7-8 Feb 2024 Live online
  • Also: 5-6 Jun 2024 Classroom
  • Also: 15-16 Oct 2024 Live online

Process Validation for Medical Devices

New for 2024

Live online, Classroom

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

  • 12 CPD hours
  • Presented by Stuart Angell
  • Next: 16-17 Jan 2024 Live online
  • Also: 21-22 May 2024 Live online
  • Also: 23-24 Sep 2024 Classroom

Process Validation with Qualification

Live online, Classroom

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours Focused
  • Presented by Bruce Davis
  • Next: 17-18 Jan 2024 Live online
  • Also: 1-2 May 2024 Live online
  • Also: 11-12 Sep 2024 Live online

Registration of Veterinary Vaccines in the USA and Canada

Live online

This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.

  • 6 CPD hours
  • Presented by Nick Wills
  • Next: 29-30 Jan 2024 Live online
  • Also: 13-14 May 2024 Classroom
  • Also: 24-25 Sep 2024 Live online

Regulatory Affairs for Support Staff

Live online, Classroom

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 27 Oct 2023 Live online
  • Also: 15 Feb 2024 Live online
  • Also: 24 Jun 2024 Live online
  • Also: 8 Oct 2024 Live online

Regulatory Strategies for Orphan Drugs

Live online

This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

  • 6 CPD hours Focused
  • Presented by Marloes van der Geer
  • Next: 4-5 Dec 2023 Live online

A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China

Live online

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China

  • 12 CPD hours Focused
  • Presented by Dr Eliana Henriquez Rodríguez
  • + 2 more
  • Next: 2 Feb 2024 Live online
  • Also: 7 Jun 2024 Live online
  • Also: 8 Oct 2024 Live online

Risk Management for Pharma and Biopharma Professionals

Live online

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 14-17 Nov 2023 Live online
  • Also: 11-12 Mar 2024 Live online
  • Also: 1-2 Jul 2024 Live online
  • Also: 12-15 Nov 2024 Live online

Signal Detection and Regulatory Expectations

Live online

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 6-7 Nov 2023 Live online
  • Also: 14 Mar 2024 Live online
  • Also: 10 Jul 2024 Live online
  • Also: 4-5 Nov 2024 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours Focused
  • Presented by Graham Howieson
  • Next: 13-14 Nov 2023 Live online
  • Also: 4-7 Mar 2024 Live online
  • Also: 11-12 Jul 2024 Live online
  • Also: 11-12 Nov 2024 Live online

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours Focused
  • Presented by Paul Palmer
  • Next: 19-20 Oct 2023 Live online

Sterilization of Medical Devices

New for 2023

Live online

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours Focused
  • Presented by Annette Callaghan
  • Next: 6-8 Dec 2023 Live online
  • Also: 20-22 Mar 2024 Live online
  • Also: 24-26 Jul 2024 Live online
  • Also: 27-29 Nov 2024 Live online

Successful Medical Writing – from Protocol to CTD

Live online

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

  • 18 CPD hours Focused
  • Presented by Barbara Grossman
  • Next: 23 Jan 2024 Live online
  • Also: 25 Apr 2024 Classroom
  • Also: 4 Jul 2024 Live online
  • Also: 4 Oct 2024 Classroom

Sustainable Design and Manufacture for Medical Devices

Live online, Classroom

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.

  • 6 CPD hours Focused
  • Presented by Cormac O'Prey
  • Next: 21 Nov 2023 Live online
  • Also: 1 Mar 2024 Live online
  • Also: 15 Jul 2024 Live online
  • Also: 19 Nov 2024 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

  • 6 CPD hours Focused
  • Presented by Janette Benaddi
  • and Dr Tina Amini
  • Next: 20-21 Nov 2023 Live online
  • Also: 13-14 Mar 2024 Live online
  • Also: 17-18 Jul 2024 Live online
  • Also: 18-19 Nov 2024 Live online

Understanding Active Pharmaceutical Ingredients (APIs) - A Comprehensive and Practical Introduction

New for 2023

Live online

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

  • 12 CPD hours Focused
  • Presented by Paul Palmer
  • Next: 27-28 Nov 2023 Live online
  • Also: 19-20 Mar 2024 Live online
  • Also: 24-25 Jul 2024 Live online
  • Also: 25-26 Nov 2024 Live online

Understanding Computer System Validation (CSV) - A Comprehensive and Practical Introduction

New for 2023

Live online

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

  • 12 CPD hours Focused
  • Presented by Paul Palmer
  • Next: 23-24 Jan 2024 Live online
  • Also: 23-24 Apr 2024 Live online
  • Also: 8-9 Jul 2024 Live online
  • Also: 8-9 Oct 2024 Live online

Understanding Pharmacovigilance Regulations in APAC

New for 2024

Live online

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours Focused
  • Presented by Ms Marylene Zhan
  • + 4 more
  • Next: 19 Mar 2024 Live online
  • Also: 18 Jul 2024 Live online
  • Also: 19 Nov 2024 Live online

US FDA - Understanding Key Factors When Working with the FDA

New for 2024

Live online

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration).  For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.  

  • 6 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 12-13 Oct 2023 Live online
  • Also: 1-2 Feb 2024 Live online
  • Also: 4-5 Jun 2024 Live online
  • Also: 10-11 Oct 2024 Live online

Variations to Marketing Authorisations

Live online

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

  • 12 CPD hours Focused
  • Presented by Marloes van der Geer
  • Next: 12-13 Dec 2023 Classroom
  • Also: 4-5 Mar 2024 Live online
  • Also: 26-27 Nov 2024 Classroom

Veterinary Pharmaceutical Submissions in the EU

Live online, Classroom

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, critical expert reports and regulatory submissions.

  • 12 CPD hours Focused
  • Presented by Andrew Hewitt
  • + 2 more
  • Recorded webcast

Human Factors - The Increasing Importance of Instructions for Use

Free

Recorded webcast

This free webinar will focus on the often overlooked but increasingly important area of Instructions for Use for medical products. From the perspective of human factors and usability engineering, Instructions for Use significantly impact the performance of the user to use medical devices safely and effectively and often are only used when the user has a problem. The webinar will look at why we need Instructions for Use to be usable, not only for safety but for regulatory approval and how you achieve that. It will address what predictions can be made from existing data and discuss what the future of Instructions for Use could be. This is an excellent opportunity to learn more about this important element of your regulatory submission.

  • 1.5 CPD hours High impact
  • Presented by Greg Thay
  • Recorded webcast

New EU GMP Annex 1 and its Impact on Pharmaceutical Manufacturers

Free

Recorded webcast

This free webinar will explain the reasons for the revision of Annex 1 and will address the changes and implications for pharmaceutical manufacturers. Topics to be covered will include how to prepare your Contamination Control Strategy (CCS) document, and how to adapt to the principles of Quality Risk Management. The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.

  • 1.5 CPD hours High impact
  • Presented by Mustafa Edik
  • Webcast & report

Sustainable Design and Manufacture for Medical Devices

Free

Webcast & report

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This free webinar will give you a high level of understanding of what sustainability options exist, what the benefits are and what drives them.

  • Presented by Cormac O'Prey
  • Self-paced

Understanding the Pharmaceutical Industry

Self-paced

A 6 MODULE SELF-MANAGED DISTANCE LEARNING COURSE – An insider’s guide to the pharmaceutical industry for anyone new who wants to enhance their knowledge on working in the pharma, bio-tech or life sciences sectors. Gain key skills needed with this 6 module course requiring 3 to 4 hours study each module.

  • John Ansell