In-house & bespoke training:
Regulatory Affairs

Our regulatory affairs training courses have been designed to update delegates on a wide range of regulatory topics, from updates on the latest regulations to registration procedures and strategies. We provide information on regulatory approval in key regions globally, with practical advice from our expert speaker panel.

 

Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book

Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers

In-house & bespoke training

The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.

Typically presented by Annette Callaghan (bio)

Typical duration: 4 days
Delivery: collaborative classroom

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A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products

In-house & bespoke training

Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU. Regulations for CMC of veterinary pharmaceuticals are complex and are regularly updated, making pharmaceutical product development challenging. This course is designed to guide you through the essential steps in development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorisation applications.

Typically presented by Craig Evans (bio) , Dave Parry (bio)

Delivery: collaborative classroom

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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 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

Rated by attendees to the public programme

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

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A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK

In-house & bespoke training

This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.

Rated by attendees to the public programme

Typically presented by Theresa Jeary (bio)
and 4 more leading experts

Typical duration: 2 days
Pricing from £1,299 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 Medical Information

In-house & bespoke training

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
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 Ethylene Oxide (EO) Sterilization for Medical Devices

In-house & bespoke training

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

Typically presented by Annette Callaghan (bio)

Delivery: collaborative classroom

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An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

In-house & bespoke training

This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

Typically presented by Greg Thay (bio)

Delivery: collaborative classroom

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An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

In-house & bespoke training

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

Typically presented by Annette Callaghan (bio)

Delivery: collaborative classroom

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An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

In-house & bespoke training

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

Typically presented by Stuart Angell (bio)

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 Philip Clay (bio) , Rona Middlemiss (bio)

Typical duration: 2 days
Pricing from £800 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 planning and implementation in process 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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Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

In-house & bespoke training

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.
This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

Rated by attendees to the public programme

Typically presented by Andrew Willis (bio)

Typical duration: 2 days
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

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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EU Pharmaceutical Regulations & Strategy

In-house & bespoke training

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.

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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EU Proposed Pharmaceutical Legislation Changes

In-house & bespoke training

On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation.
This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.

Typically presented by Norah Lightowler (bio)

Typical duration: 3 days
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.

Rated by attendees to the public programme

Typically presented by Justin Bailey (bio) , Jasbir Chohan (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Human Factors - The Increasing Importance of Instructions for Use

In-house & bespoke training

This free webinar will focus on the often overlooked but increasingly important area of Instructions for Use for medical products. From the perspective of human factors and usability engineering, Instructions for Use significantly impact the performance of the user to use medical devices safely and effectively and often are only used when the user has a problem. The webinar will look at why we need Instructions for Use to be usable, not only for safety but for regulatory approval and how you achieve that. It will address what predictions can be made from existing data and discuss what the future of Instructions for Use could be.
This is an excellent opportunity to learn more about this important element of your regulatory submission.

Rated by attendees to the public programme

Typically presented by Greg Thay (bio)

Typical duration: 90 days
Delivery: collaborative classroom

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Human Factors and Usability Engineering in the Development of Drug Delivery Products

In-house & bespoke training

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Rated by attendees to the public programme

Typically presented by Richard Featherstone (bio)

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

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ICH Q9(R1) Quality Risk Management (QRM)

In-house & bespoke training

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

Typically presented by Bruce Davis (bio)

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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Managing Competence within the Medical Device Industry

In-house & bespoke training

This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.

Typically presented by Anne Jury (bio)

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.

Rated by attendees to the public programme

Typically presented by Stuart Angell (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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Navigating China’s API Regulations: An Essential Guide to DMF Registration

In-house & bespoke training

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

Typically presented by Raymond Ng (bio) , Helen Ye (bio)

Delivery: collaborative classroom

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Non-Conformance and Corrective Action for Medical Device Manufacturers

In-house & bespoke training

The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.

Typically presented by Annette Callaghan (bio)

Typical duration: 4 days
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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Post-Market Surveillance - Practical Application for Medical Devices and IVDs

In-house & bespoke training

Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.
This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities.

Typically presented by Anne Jury (bio) , Karen Pearson (bio)

Typical duration: 1 day
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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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 Andrew Willis (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.

Rated by attendees to the public programme

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.

Rated by attendees to the public programme

Typically presented by Annette Callaghan (bio)

Delivery: collaborative classroom

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The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA

In-house & bespoke training

This practical four-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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The Common Technical Document (CTD) Submission in the MENA Region

In-house & bespoke training

This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.

Typically presented by Mohammad Fat'hy Elnadi (bio)

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 Andrew Willis (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 Stuart Angell (bio)
and 7 more leading experts

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

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The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

In-house & bespoke training

This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.

Typically presented by Stuart Angell (bio)

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.

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio)

Delivery: collaborative classroom

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Understanding Active Pharmaceutical Ingredients (APIs)

In-house & bespoke training

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

Typically presented by Paul Palmer (bio)

Typical duration: 2 days
Delivery: collaborative classroom

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Understanding Computer System Validation (CSV)

In-house & bespoke training

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

Rated by attendees to the public programme

Typically presented by Paul Palmer (bio)

Typical duration: 2 days
Delivery: collaborative classroom

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US FDA - Understanding Key Factors When Working with the FDA

In-house & bespoke training

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration).  For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.  

Typically presented by Andrew Willis (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 Andrew Willis (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, critical expert reports and regulatory submissions.

Rated by attendees to the public programme

Typically presented by Andrew Hewitt (bio) , Dave Parry (bio)

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

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John Price explained all information in practical and useful way. I have been satisfied from the whole shapes of the program. For sure I will recommend it to other colleagues

Marco Taras, Regulatory Affairs, Philogen S.p.A.

The webinar content corresponded to what I was expecting ; I thought it was very good that Andrew asked the participants lots of questions as it made the webinar more enjoyable and engaging.

Liz Hui, Regulatory Affairs Executive, Dermal Laboratories Ltd

Excellent, it was very interesting and I find the speaker very knowledgeable.

Kolbrun E Ottosdottir, , Nox Medical

Very nice. I would recommend.

Magali Rigo, RA Pharma Manager, Boehringer Ingelheim Animal Health

Very knowledgeable, up to date on things in this field even parts you usually do not get a glimpse in. An excellent program.

Harpa Arnardóttir, Chief Quality Officer, Nox Medical

Very passionate and answered questions clearly

Genn Kamei, , Nox Medical

I wanted to get some good practices on how to manage dossier from a strategic and admin standpoint. Recommendations were given during the training so I think info I wanted to get was given.

Karine Tanan, Principal Scientist, Scientific and Regulatory Affairs, Cargill R and D Centre Europe

Laura is an exceptional expert in her field and it is great to have someone so knowledgeable and qualified to train on this topic.

Kimberley Ormerod, Senior Group HR Manager, Boyds

Laura is an exceptional expert in her field and it is great to have someone so knowledgeable and qualified to train on this topic.

Kimberley Ormerod, Senior Group HR Manager, Boyds

The content are useful for my purpose, I receive additional and detailed information. The presentation and speakers are very clear.

Adriana Merlicco, Regulatory, Alfasigma S.p.A.