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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

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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 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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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 Michelle Kelly (bio) , Jeremy Tinkler (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) , Penny Viner (bio)

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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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

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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

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

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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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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

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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 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 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

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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 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

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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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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

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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.

Typically presented by Nick Wills (bio)

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 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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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

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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 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

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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 Karolina Bate (bio) , Mel Munro (bio)

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

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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

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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 Joanne Roza (bio) , 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 Andrew Hewitt (bio) , Colin McLean (bio) , Dave Parry (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 Andrew Hewitt (bio) , David Petrick (bio)

Typical duration: 5 days
Pricing from £1,500 per attendee
Delivery: collaborative classroom

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Absolutely fantastic. I needed to be able to communicate more effectively with my Regulatory colleagues and I believe the information I have learned on this course will assist me to do that

Jenny Ramsey, Quality Engineer - Compliance, Pfizer R&D UK Ltd

My intent was to get an overall picture of the lay out of a vaccine registration dossier, content and submission timelines. Thanks to the extensive course, I got a full and complete tool box... the webinar has been very enjoyable, informative. Congratulations to both speakers because It is not an easy exercise when addressing attendants through screens.

Frédérique Cernicchiaro, Specialiste Pharmacovigilance Globale, Boehringer Ingelheim

My intent was to get an overall picture of the lay out of a vaccine registration dossier, content and submission timelines. Thanks to the extensive course, I got a full and complete tool box.

Frédérique Cernicchiaro, Specialiste Pharmacovigilance Globale, Boehringer Ingelheim

Excellent would attend other similar webinar/trainings

Cheryl Dicks, Sr. Mgr. Regulatory, CANbridge Pharmaceuticals

All was great, no complaints!

Angelica Morreno, Regulatory Affairs Assistant, Sinclair Pharmaceuticals

I was hoping to get more information regarding 510(k) submissions. I am very happy that I got the opportunity to learn much more. I learned a lot and feel more confident about my understanding of the submission processes.

Natale Rolim, Project Manager, EpiGuard

I was happy to attend to this webinar and it was really useful and well-explained and organized.

Mireia Crosa, Regulatory and Compliance Specialist, Diagnostic Grifols, S.A.

I think it was especially helpful for the slightly advanced in these areas.

Ladislav Pazout, Production director, DYNTEC, spol. s r. o.

Excellent - speakers were very, very knowledgeable, kept things interesting, lots of opportunity for questions..

Róisín Byrne, Senior Regulatory Affairs Officer, Ayrton Saunders Limited

I did get some interesting information that may be useful when writing these documents in the future.

Nele Hilgert, Medical Writer, Emtex Life Science