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Training courses & Webinars:
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
15-16 Sep 2022 - London
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.
Advanced Regulatory Affairs for Medical Devices
27-28 Sep 2022 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
An Essential Overview of the Medical Device Industry
2 Nov 2022 - Online webinar
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.
An Essential Overview of the Pharmaceutical and Biotech Industries
16 Sep 2022 - Online webinar
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
Presented by Laura Brown (bio)
An Introduction to the Medical Device Regulation
1-3 Aug 2022 - London
Also on: 8 Nov 2022
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.
Best Practice for Writing Effective SOPs
19 Sep 2022 - London
Also on: 12 Dec 2022
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Borderlines between Medicines and Food
1 Dec 2022 - Online webinar
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
CAPA (Corrective and Preventative Action)
20 Sep 2022 - London
Also on: 13 Dec 2022
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.
Presented by Laura Brown (bio)
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
5-6 Oct 2022 - Online webinar
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)
Presented by John Price (bio)
Cyber Security for Medical Devices
19 Jul 2022 - Online webinar
Also on: 11 Oct 2022
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.
Presented by Ben Kokx (bio)
Drug/Device and Device/Drug Combinations in the EU and USA
29-30 Sep 2022 - Online webinar
Also on: 14 Dec 2022
Practical guidance on borderline Issues and combination products
Presented by
Tina Amini (bio)
and 3 more leading experts
EU Pharmaceutical Regulations & Strategy
18-19 Oct 2022 - Online webinar
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.
Presented by Norah Lightowler (bio)
FDA Approval Process for Medical Devices
12-13 Sep 2022 - Online webinar
Also on: 5 Dec 2022
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.
Presented by Jonathan Hughes (bio)
Filing eCTD Submissions
19 Oct 2022 - Online webinar
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
3-4 Nov 2022 - Online webinar
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.
Medical Device Regulation in the Eurasian Union, Russia and the CIS
5-6 Jul 2022 - Online webinar
Also on: 12 Oct 2022
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.
Presented by Anna Harrington-Morozova (bio)
Medical Device Regulations in the Middle East and North Africa
20-21 Sep 2022 - London
Also on: 7 Dec 2022
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
Medical Device Single Audit Programme (MDSAP)
1-2 Dec 2022 - London
Also on: 23 Mar 2023
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.
Presented by Eamonn Hoxey (bio)
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
18-21 Oct 2022 - Online webinar
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
New Regulations for Medical Devices and IVDs in Europe
13-14 Oct 2022 - Online webinar
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.
Pharmaceutical Regulatory Affairs in Africa
23-24 Nov 2022 - Online webinar
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Pharmaceutical Regulatory Affairs in Asia
12-14 Oct 2022 - Online webinar
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
Pharmaceutical Regulatory Affairs in China
22-23 Nov 2022 - Online webinar
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
15-16 Aug 2022 - Online webinar
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Presented by Anna Harrington-Morozova (bio)
Pharmaceutical Regulatory Affairs in the Middle East
14-15 Dec 2022 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Registration of Veterinary Vaccines in the USA and Canada
14-15 Sep 2022 - Online webinar
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.
Presented by Nick Wills (bio)
Regulatory Affairs for Support Staff
27-28 Sep 2022 - Online webinar
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.
Presented by Norah Lightowler (bio)
Regulatory Strategies for Orphan Drugs
26 Sep 2022 - Online webinar
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer (bio)
Risk Management for Pharma and Biopharma Professionals
14 Oct 2022 - Online webinar
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.
Presented by Laura Brown (bio)
Sterilization of Medical Devices
20-21 Oct 2022 - Online webinar
Also on: 2 Feb 2023
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.
Presented by Eamonn Hoxey (bio)
Technical Documentation to Comply with the MDR and IVDR
22-23 Nov 2022 - Online webinar
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.
The FDA Drug Approval Process
19-20 Sep 2022 - Online webinar
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
The Medical Device School - From Concept to CE Marking
5-9 Dec 2022 - Online webinar
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.
Presented by Janette Benaddi (bio)
The New EU Animal Health Legislation for Veterinary Medicinal Products
3-4 Nov 2022 - Online webinar
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.
UK Conformity Assessed (UKCA) Marking for Medical Devices
13 Jul 2022 - Online webinar
Also on: 3 Nov 2022
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.
Presented by Janette Benaddi (bio)
Variations to Marketing Authorisations
7-8 Jul 2022 - Online webinar
Also on: 13 Oct 2022
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.
Veterinary Pharmaceutical Submissions in the EU
13-14 Dec 2022 - Online webinar
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.
Working Through Veterinary Drug Development in the EU and USA
12-16 Sep 2022 - Online webinar
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.