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In-house & bespoke training:
Regulatory
Our regulatory training courses have been designed to update delegates on a wide range of regulatory affairs 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.
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Tamsin Dawson (bio) , Mel Munro (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Advanced Regulatory Affairs for Medical Devices
In-house & bespoke training
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Rated by attendees to the public programme
Typically presented by Janette Benaddi (bio) , Theresa Jeary (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
An Essential Overview of the Medical Device Industry
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Theresa Jeary (bio) , David Jefferys (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
An Essential Overview of the Pharmaceutical and Biotech Industries
In-house & bespoke training
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
Rated by attendees to the public programme
Typically presented by Laura Brown (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
An Introduction to the Medical Device Regulation
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Janette Benaddi (bio) , Will Burton (bio) , Theresa Jeary (bio)
| Typical duration: 3 days | |
| Pricing from £1,200 per attendee | |
| Delivery: collaborative classroom |
Best Practice for Writing Effective SOPs
In-house & bespoke training
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Rated by attendees to the public programme
Typically presented by Laura Brown (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Biological Evaluation of Medical Devices
In-house & bespoke training
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
Rated by attendees to the public programme
Typically presented by Michelle Kelly (bio) , Jeremy Tinkler (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Borderlines between Medicines and Food
In-house & bespoke training
This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them
Rated by attendees to the public programme
Typically presented by Brian Kelly (bio) , Penny Viner (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
CAPA (Corrective and Preventative Action)
In-house & bespoke training
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.
Rated by attendees to the public programme
Typically presented by Laura Brown (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
In-house & bespoke training
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)
Rated by attendees to the public programme
Typically presented by John Price (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Cyber Security for Medical Devices
In-house & bespoke training
The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. 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.
Rated by attendees to the public programme
Typically presented by Ben Kokx (bio)
| Typical duration: 1 day | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Drug/Device and Device/Drug Combinations in the EU and USA
In-house & bespoke training
Practical guidance on borderline Issues and combination products
Rated by attendees to the public programme
Typically presented by
Tina Amini (bio)
and 3 more leading experts
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
EU Pharmaceutical Regulations & Strategy
In-house & bespoke training
This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.
Rated by attendees to the public programme
Typically presented by Norah Lightowler (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
FDA Approval Process for Medical Devices
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Jonathan Hughes (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Filing eCTD Submissions
In-house & bespoke training
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Typically presented by Maikel Bouman (bio) , Marloes van der Geer (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Stuart Angell (bio) , Nancy Consterdine (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Medical Device Regulation in the Eurasian Union, Russia and the CIS
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Anna Harrington-Morozova (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Medical Device Regulations in the Middle East and North Africa
In-house & bespoke training
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
Rated by attendees to the public programme
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Medical Device Single Audit Programme (MDSAP)
In-house & bespoke training
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.
Typically presented by Eamonn Hoxey (bio)
| Delivery: collaborative classroom |
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
In-house & bespoke training
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Rated by attendees to the public programme
Typically presented by Koen Cobbaert (bio) , Zuzanna Kwade (bio)
| Typical duration: 3 days | |
| Pricing from £1,200 per attendee | |
| Delivery: collaborative classroom |
New Regulations for Medical Devices and IVDs in Europe
In-house & bespoke training
During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.
Rated by attendees to the public programme
Typically presented by Janette Benaddi (bio) , Theresa Jeary (bio) , David Jefferys (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Pharmaceutical Regulatory Affairs in Africa
In-house & bespoke training
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Rated by attendees to the public programme
Typically presented by Salma Ismail (bio) , Makram Nehme (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Pharmaceutical Regulatory Affairs in Asia
In-house & bespoke training
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
Rated by attendees to the public programme
Typically presented by Alan Chalmers (bio) , Monica Dressler-Meyer (bio)
| Typical duration: 3 days | |
| Pricing from £1,200 per attendee | |
| Delivery: collaborative classroom |
Pharmaceutical Regulatory Affairs in China
In-house & bespoke training
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Rated by attendees to the public programme
Typically presented by Alan Chalmers (bio) , Monica Dressler-Meyer (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
In-house & bespoke training
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Rated by attendees to the public programme
Typically presented by Anna Harrington-Morozova (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Pharmaceutical Regulatory Affairs in the Middle East
In-house & bespoke training
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Rated by attendees to the public programme
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Registration of Animal Feed Additives in the EU
In-house & bespoke training
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
Rated by attendees to the public programme
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Registration of Veterinary Vaccines in the USA and Canada
In-house & bespoke training
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.
Typically presented by Nick Wills (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Regulatory Affairs for Support Staff
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Norah Lightowler (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Regulatory Strategies for Orphan Drugs
In-house & bespoke training
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Rated by attendees to the public programme
Typically presented by Marloes van der Geer (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Risk Management for Pharma and Biopharma Professionals
In-house & bespoke training
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.
Typically presented by Laura Brown (bio)
| Delivery: collaborative classroom |
Sterilization of Medical Devices
In-house & bespoke training
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.
Typically presented by Eamonn Hoxey (bio)
| Delivery: collaborative classroom |
Technical Documentation to Comply with the MDR and IVDR
In-house & bespoke training
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
Rated by attendees to the public programme
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
The FDA Drug Approval Process
In-house & bespoke training
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Rated by attendees to the public programme
Typically presented by Hans van Bruggen (bio) , Marloes van der Geer (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
The Medical Device School - From Concept to CE Marking
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Janette Benaddi (bio)
| Typical duration: 5 days | |
| Pricing from £1,500 per attendee | |
| Delivery: collaborative classroom |
The New EU Animal Health Legislation for Veterinary Medicinal Products
In-house & bespoke training
The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.
Rated by attendees to the public programme
Typically presented by Karolina Bate (bio) , Mel Munro (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
UK Conformity Assessed (UKCA) Marking for Medical Devices
In-house & bespoke training
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.
Typically presented by Janette Benaddi (bio)
| Delivery: collaborative classroom |
Variations to Marketing Authorisations
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Joanne Roza (bio) , Marloes van der Geer (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Veterinary Pharmaceutical Submissions in the EU
In-house & bespoke training
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.
Rated by attendees to the public programme
Typically presented by Andrew Hewitt (bio) , Colin McLean (bio) , Dave Parry (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Working Through Veterinary Drug Development in the EU and USA
In-house & bespoke training
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
Rated by attendees to the public programme
Typically presented by Andrew Hewitt (bio) , David Petrick (bio)
| Typical duration: 5 days | |
| Pricing from £1,500 per attendee | |
| Delivery: collaborative classroom |