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Training courses & Webinars:
Regulatory
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
9-10 Mar 2021 - Online webinar
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.
A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
2-3 Dec 2021 - Online webinar
Also on: 9 Dec 2021
Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.
Presented by Elinor McCartney (bio)
Advanced Regulatory Affairs for Medical Devices
20-21 Apr 2021 - Online webinar
Also on: 28 Sep 2021
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
An Essential Overview of the Medical Device Industry
13 May 2021 - Online webinar
Also on: 18 Oct 2021
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
7 May 2021 - Online webinar
Also on: 16 Sep 2021
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
12-14 May 2021 - Online webinar
Also on: 10 Nov 2021
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.
Biological Evaluation of Medical Devices
18-19 May 2021 - London
Also on: 23 Nov 2021
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
Borderlines between Medicines and Food
9 Dec 2021 - London
Also on: 10 Dec 2021
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
Presented by Penny Viner (bio)
CAPA (Corrective and Preventative Action)
29 Jun 2021 - Online webinar
Also on: 3 Dec 2021
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
30 Mar 2021 - 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)
Drug/Device and Device/Drug Combinations in the EU and USA
28-29 Apr 2021 - Online webinar
Practical guidance on borderline Issues and combination products
EU Pharmaceutical Regulations & Strategy
19-20 Apr 2021 - Online webinar
Also on: 18 Oct 2021
This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations
Presented by Norah Lightowler (bio)
FDA Approval Process for Medical Devices
24-25 Mar 2021 - Online webinar
Also on: 13 Sep 2021
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
13 Apr 2021 - Online webinar
Also on: 18 Oct 2021
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
How to Write Effective SOPs
28 Jun 2021 - Online webinar
Also on: 2 Dec 2021
An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.
Presented by Laura Brown (bio)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
11-12 May 2021 - Online webinar
Also on: 2 Nov 2021
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
6-7 Oct 2021 - Online webinar
Also on: 13 Oct 2021
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
30 Jun-1 Jul 2021 - Online webinar
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 Software: Complying with the MDR & FDA Regulations
28-30 Apr 2021 - Online webinar
Also on: 27 Oct 2021
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
New Medical Device Regulation
17-18 Mar 2021 - Online webinar
Also on: 12 Oct 2021
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.
Periodic Safety Update Reports for Veterinary Medicinal Products
11-12 May 2021 - Online webinar
Also on: 19 Oct 2021
Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit
*NEW EVENT!*
Presented by Declan O'Rourke (bio)
Pharmaceutical Regulatory Affairs in Africa
22-23 Mar 2021 - Online webinar
Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.
Presented by Salma Ismail (bio)
Pharmaceutical Regulatory Affairs in Asia
7-9 Apr 2021 - 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
17-18 Nov 2021 - London
Also on: 24 Nov 2021
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
4-5 Feb 2021 - 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
28-29 Jun 2021 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Registration of Animal Feed Additives in the EU
16-17 Jun 2021 - Online webinar
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
Registration of Veterinary Vaccines in the USA and Canada
11 Mar 2021 - 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 Donna Mattson (bio)
Regulatory Affairs for Support Staff
18-19 Mar 2021 - Online webinar
Also on: 27 Sep 2021
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
10 Mar 2021 - Online webinar
Also on: 22 Sep 2021
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Andrew Willis (bio)
Risk Management for Pharma and Biopharma Professionals
22 Mar 2021 - Online webinar
Also on: 21 Sep 2021
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)
Technical Documentation to Comply with the MDR and IVDR
10-11 Mar 2021 - Online webinar
Also on: 22 Nov 2021
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
11-12 Mar 2021 - Online webinar
Also on: 20 Sep 2021
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Presented by Andrew Willis (bio)
The Medical Device Summer School - From Concept to CE Marking
5-9 Jul 2021 - London
*A practical five-day course with interactive workshops - now in its 17th successful year!*
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
Nick Baker (bio)
and 8 more leading experts
The New EU Animal Health Legislation for Veterinary Medicinal Products
5-6 May 2021 - Online webinar
Also on: 2 Nov 2021
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.
*INCLUDES: Interactive discussion sessions*
Presented by Julian Braidwood (bio)
Variations to Marketing Authorisations
25-26 Mar 2021 - Online webinar
Also on: 7 Oct 2021
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.
Presented by Andrew Willis (bio)
Veterinary Pharmaceutical Submissions in the EU
3-4 Mar 2021 - Online webinar
Also on: 6 Dec 2021
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.
Presented by Julian Braidwood (bio)
Working Through Veterinary Drug Development in the EU and USA
7-10 Jun 2021 - London
This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.