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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 |
A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
In-house & bespoke training
Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.
Rated by attendees to the public programme
Typically presented by
Joan Castelló Latorre (bio)
and 4 more leading experts
| 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 Medical Device Industry - the Key Considerations
In-house & bespoke training
This short and concise webinar will provide the essentials of how medical devices and diagnostics are regulated. With changes being introduced this summer, this is an event you cannot afford to miss!
90 minute live webinar
14:00 (UK/London Time Zone)
| 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 |
Basic Principles of Pharmacokinetics
In-house & bespoke training
An introduction and overview of the main principles and concepts of Pharmacokinetics relating to drug discovery and development.
| Typical duration: 2 days | |
| Pricing from £800 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 Philip Clay (bio) , Janine Ingleby (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) , David Richardson (bio) , Penny Viner (bio)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Brexit Webinar - Impact on Pharmaceutical / Medical Devices Industries
In-house & bespoke training
Brexit Update - What will happen next?
14.15 (GMT)
Rated by attendees to the public programme
| 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 |
Developing Medicines for Companion Animals in the EU
In-house & bespoke training
This *In-house* course will provide a comprehensive introduction to the entire development programme for companion animal medicines.
| Typical duration: 4 days | |
| Pricing from £1,400 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
The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.
The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.
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 |
Exploring Routes to Market for Herbals
In-house & bespoke training
Acquire key skills to maximise success in an expanding herbal product market.
| Typical duration: 1 day | |
| Pricing from £450 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 |
Impact of the Medical Device Regulation (MDR)
In-house & bespoke training
Are you prepared and what next?
14.00 (GMT)
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Intellectual Property for Pharma Regulatory Affairs
In-house & bespoke training
Understand the impact of IP on pharmaceutical regulatory strategy
| Typical duration: 1 day | |
| Pricing from £450 per attendee | |
| Delivery: collaborative classroom |
Introduction to the Development and Licensing of Veterinary Novel Biotherapeutics in the EU
In-house & bespoke training
In this *In-house* course, discover how to develop veterinary pharmaceuticals and vaccines, its regulatory landscape and how you might apply these principles to novel biotherapeutics.
| 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)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
ISO 13485: Quality Management Systems for Medical Devices
In-house & bespoke training
Compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971 'Application to Risk Management to Medical Devices'.
Rated by attendees to the public programme
| 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 Asia-Pacific Markets
In-house & bespoke training
Gain practical advice on how regulations are being applied to enable you to take full advantage of this rapidly growing market.
| 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 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 Medical Device Regulation
In-house & bespoke training
Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.
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 |
Periodic Safety Update Reports for Veterinary Medicinal Products
In-house & bespoke training
Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit
*NEW EVENT!*
Typically presented by Declan O'Rourke (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 |
Pharmaceutical Regulatory Affairs in the Middle East, Dubai
In-house & bespoke training
This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.
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
Typically presented by Elinor McCartney (bio)
| 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.
| 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 new 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 |
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 end of the Brexit Transition Period – Impact on Medical Device Industry
In-house & bespoke training
The very latest information and operational experiences to be shared.
90 minute live webinar
14:00 (UK/London Time Zone)
Rated by attendees to the public programme
| Delivery: collaborative classroom |
The end of the Brexit Transition Period – Impact on Pharmaceutical Industry
In-house & bespoke training
The very latest information and operational experiences to be shared.
90 minute live webinar
14:00 (UK/London Time Zone)
Rated by attendees to the public programme
| 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
| 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 Julian Braidwood (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| 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 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 Julian Braidwood (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 Julian Braidwood (bio) , David Petrick (bio)
| Typical duration: 5 days | |
| Pricing from £1,500 per attendee | |
| Delivery: collaborative classroom |