Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

Typically presented by Heba Hashem (bio) , Ilona Putz (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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

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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

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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

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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

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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

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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

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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

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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

Typically presented by Heba Hashem (bio) , Ilona Putz (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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

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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

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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

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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

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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

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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

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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

Typically presented by Will Burton (bio) , Paul Sim (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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

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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

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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

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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

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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

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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

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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

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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

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A good and well thought out webinar with very intelligent presenter.

Ifesinachi Onyekaba, Research and Development Specialist, MEDTRON AG

Great session, thank you

Kasia Stathers, Vigilance Officer , Reckitt Benckiser Group

I wanted to learn more about regulations in the middle east and the content was definitely very informative. The speakers had a lot of knowledge, there were a few technical issues however these were quickly resolved.

Hafsa Khan, Regulatory Associate, Gilead Sciences International Ltd

The webinar was prepared in a high quality manner.

Michel Salatiel Guzman Gomez, , Boehringer Ingelheim Vetmedica GmbH

Excellent speakers, different styles but all very good.

Dora Rodriguez, Regulatory Affairs Director, Jefo Nutrition Inc.

It was a well structured, well presented webinar with engaging speakers.
I came away feeling like I have a much better understanding about the US regulatory system. The content covered a wide range of areas, and although not all was relevant to me, it was interesting and valuable.

Jenny Lakin, Head of Product Registration, Torbay Pharmaceuticals

Very informative and good.

Jayesh Tangutoori Mohan, Senior RA Manager, Atnahs Pharma UK Limited

Really useful refresher on CAPA and the processes used. It has helped me prioritise and categorise CAPA types, and I found particularly useful the section on risk scoring and utilising the risk register for those classified as minor.

Claire Crewe, QA Maanger, JensonR+

Overall it was a good informative webinar. Content was detailed.

Tarak Patel, Regulatory Affairs Manager, Syri Limited

The content was very useful and all speakers were at adequate level. Workshops helped me a lot to digest the content of presentations.

Athanasios Karalis, Product Stewardship Manager, IMERYS INDUSTRIAL MINERALS S.A