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Training courses & Webinars:
Regulatory Affairs
Our regulatory affairs training courses have been designed to update delegates on a wide range of regulatory topics, from updates on the latest regulations to registration procedures and strategies. We provide information on regulatory approval in key regions globally, with practical advice from our expert speaker panel.
Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book
Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
4 Jun 2024 - Online webinar
Also on: 5 Dec 2024
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.
Presented by Annette Callaghan (bio)
A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
18 Mar 2024 - Online webinar
Also on: 5 Nov 2024
Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU. Regulations for CMC of veterinary pharmaceuticals are complex and are regularly updated, making pharmaceutical product development challenging. This course is designed to guide you through the essential steps in development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorisation applications.
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
11-12 Mar 2024 - Online webinar
Also on: 11 Nov 2024
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.
Presented by Mel Munro (bio)
A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
4-5 Dec 2023 - Online webinar
Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China
Presented by
Bo Yang (bio)
and 4 more leading experts
Advanced Regulatory Affairs for Medical Devices
1-2 Feb 2024 - Online webinar
Also on: 4 Jun 2024
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
An Essential Overview of Medical Information
15 Mar 2024 - Online webinar
Also on: 11 Jul 2024
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
Presented by Graeme Ladds (bio)
An Essential Overview of the Medical Device Industry
1 Mar 2024 - Online webinar
Also on: 8 Jul 2024
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.
An Essential Overview of the Pharmaceutical and Biotech Industries
19 Jan 2024 - Online webinar
Also on: 10 May 2024
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
Presented by Laura Brown (bio)
An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
1 May 2024 - Online webinar
Also on: 11 Nov 2024
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.
Presented by Annette Callaghan (bio)
An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
24 Apr 2024 - Online webinar
Also on: 10 Jul 2024
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 (bio)
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
21 May 2024 - Online webinar
Also on: 18 Nov 2024
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.
Presented by Annette Callaghan (bio)
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
6 Mar 2024 - Online webinar
Also on: 4 Jul 2024
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.
Presented by Stuart Angell (bio)
An Introduction to the Medical Device Regulation
6-8 Feb 2024 - Online webinar
Also on: 15 May 2024
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.
Best Practice for Writing Effective SOPs
14 Dec 2023 - Online webinar
Also on: 23 Apr 2024
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Biological Evaluation of Medical Devices
11-12 Mar 2024 - London
Also on: 16 Sep 2024
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
CAPA (Corrective and Preventative Action)
15 Dec 2023 - Online webinar
Also on: 22 Apr 2024
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.
Presented by Laura Brown (bio)
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
29 Feb-1 Mar 2024 - Online webinar
Also on: 27 Jun 2024
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.
Presented by Andrew Willis (bio)
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
7-8 Feb 2024 - Online webinar
Also on: 19 Jun 2024
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)
Presented by John Price (bio)
Cyber Security for Medical Devices
30-31 Jan 2024 - Online webinar
Also on: 2 May 2024
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.
Presented by Ben Kokx (bio)
Drug/Device and Device/Drug Combinations in the EU and USA
14-15 Feb 2024 - Online webinar
Also on: 17 Oct 2024
Practical guidance on borderline Issues and combination products
EU Pharmaceutical Regulations & Strategy
12-13 Feb 2024 - Online webinar
Also on: 11 Jun 2024
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.
Presented by Norah Lightowler (bio)
EU Proposed Pharmaceutical Legislation Changes
24 Jan 2024 - Online webinar
Also on: 22 May 2024
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.
Presented by Norah Lightowler (bio)
FDA Approval Process for Medical Devices
4-7 Mar 2024 - Online webinar
Also on: 19 Jun 2024
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.
Presented by Jonathan Hughes (bio)
Filing eCTD Submissions
25 Apr 2024 - Online webinar
Also on: 19 Jul 2024
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Human Factors and Usability Engineering in the Development of Drug Delivery Products
5-6 Mar 2024 - Online webinar
Also on: 5 Jun 2024
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.
Presented by Richard Featherstone (bio)
ICH Q9(R1) Quality Risk Management (QRM)
31 Jan 2024 - Online webinar
Also on: 1 May 2024
ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.
Presented by Bruce Davis (bio)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
7-8 Mar 2024 - Online webinar
Also on: 24 Jul 2024
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.
Managing Competence within the Medical Device Industry
1 May 2024 - Online webinar
Also on: 5 Nov 2024
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.
Presented by Anne Jury (bio)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
11-12 Dec 2023 - Online webinar
Also on: 16 Apr 2024
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.
Presented by Anna Harrington-Morozova (bio)
Medical Device Regulations in the Middle East and North Africa
5-6 Feb 2024 - Online webinar
Also on: 11 Jun 2024
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
Medical Device Single Audit Programme (MDSAP)
30 Nov-1 Dec 2023 - Online webinar
Also on: 25 Mar 2024
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.
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
11-14 Dec 2023 - Online webinar
Also on: 22 Apr 2024
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Navigating China’s API Regulations: An Essential Guide to DMF Registration
1 Feb 2024 - Online webinar
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.
Non-Conformance and Corrective Action for Medical Device Manufacturers
19 Jun 2024 - Online webinar
Also on: 12 Dec 2024
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.
Presented by Annette Callaghan (bio)
Pharmaceutical Regulatory Affairs in Africa
7-8 Mar 2024 - Online webinar
Also on: 23 Jul 2024
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Pharmaceutical Regulatory Affairs in Asia
27-29 Feb 2024 - Online webinar
Also on: 12 Jun 2024
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
Pharmaceutical Regulatory Affairs in China
12-13 Dec 2023 - Online webinar
Also on: 29 Apr 2024
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
8-9 Feb 2024 - Online webinar
Also on: 24 Jun 2024
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Presented by Anna Harrington-Morozova (bio)
Pharmaceutical Regulatory Affairs in the Middle East
22-23 Apr 2024 - Online webinar
Also on: 17 Jul 2024
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Registration of Veterinary Vaccines in the USA and Canada
17-18 Jan 2024 - Online webinar
Also on: 1 May 2024
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.
Presented by Nick Wills (bio)
Regulatory Affairs for Support Staff
29-30 Jan 2024 - Online webinar
Also on: 13 May 2024
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.
Presented by Norah Lightowler (bio)
Regulatory Strategies for Orphan Drugs
15 Feb 2024 - Online webinar
Also on: 24 Jun 2024
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer (bio)
Risk Management for Pharma and Biopharma Professionals
2 Feb 2024 - Online webinar
Also on: 7 Jun 2024
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.
Presented by Laura Brown (bio)
Sterilization of Medical Devices
1-2 Feb 2024 - Online webinar
Also on: 6 Jun 2024
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.
Presented by Annette Callaghan (bio)
The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA
17-20 Jun 2024 - London
This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
The Common Technical Document (CTD) Submission in the MENA Region
14 Mar 2024 - Online webinar
Also on: 10 Jul 2024
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.
Presented by Mohammad Fat'hy Elnadi (bio)
The FDA Drug Approval Process
6-7 Feb 2024 - Online webinar
Also on: 12 Jun 2024
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
The Medical Device School - From Concept to CE Marking
10-14 Jun 2024 - London
Also on: 2 Dec 2024
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.
Presented by
Stuart Angell (bio)
and 7 more leading experts
The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
24 Jan 2024 - Online webinar
Also on: 21 May 2024
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.
Presented by Stuart Angell (bio)
UK Conformity Assessed (UKCA) Marking for Medical Devices
1 Mar 2024 - Online webinar
Also on: 15 Jul 2024
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.
Presented by Janette Benaddi (bio)
Understanding Active Pharmaceutical Ingredients (APIs)
13-14 Mar 2024 - Online webinar
Also on: 17 Jul 2024
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.
Presented by Paul Palmer (bio)
Understanding Computer System Validation (CSV)
19-20 Mar 2024 - Online webinar
Also on: 24 Jul 2024
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.
Presented by Paul Palmer (bio)
US FDA - Understanding Key Factors When Working with the FDA
19 Mar 2024 - Online webinar
Also on: 18 Jul 2024
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.
Presented by Andrew Willis (bio)
Variations to Marketing Authorisations
1-2 Feb 2024 - Online webinar
Also on: 4 Jun 2024
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.
Presented by Marloes van der Geer (bio)
Veterinary Pharmaceutical Submissions in the EU
12-13 Dec 2023 - London
Also on: 4 Mar 2024
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.