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Training courses & Webinars:
Regulatory
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
6-7 Sep 2021 - Online webinar
Also on: 17 Mar 2022
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: 1 Jun 2022
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
28-29 Sep 2021 - Online webinar
Also on: 1 Mar 2022
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
An Essential Overview of the Medical Device Industry
18 Oct 2021 - Online webinar
Also on: 23 May 2022
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
17 Sep 2021 - Online webinar
Also on: 1 Mar 2022
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
10-12 Nov 2021 - Online webinar
Also on: 8 Feb 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
20 Sep 2021 - London
Also on: 2 Dec 2021
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Biological Evaluation of Medical Devices
23-24 Nov 2021 - London
Also on: 8 Feb 2022
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
10 Dec 2021 - Online webinar
Also on: 16 Jun 2022
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)
21 Sep 2021 - London
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
10 Sep 2021 - Online webinar
Also on: 30 Mar 2022
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
29-30 Sep 2021 - Online webinar
Also on: 1 Dec 2021
Practical guidance on borderline Issues and combination products
EU Pharmaceutical Regulations & Strategy
21-22 Oct 2021 - Online webinar
Also on: 11 Apr 2022
This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.
The impact of the end of the Brexit transition period will be discussed.
Presented by Norah Lightowler (bio)
FDA Approval Process for Medical Devices
15-16 Sep 2021 - Online webinar
Also on: 29 Mar 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
20 Oct 2021 - Online webinar
Also on: 18 Jan 2022
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)
2-3 Nov 2021 - Online webinar
Also on: 19 May 2022
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: 12 Apr 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
8-9 Dec 2021 - Online webinar
Also on: 15 Jun 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 Software: Complying with the EU MDR, EU IVDR & FDA Regulations
26-29 Oct 2021 - Online webinar
Also on: 25 Apr 2022
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
New Medical Device Regulation
11-12 Oct 2021 - Online webinar
Also on: 12 Apr 2022
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.
Pharmaceutical Regulatory Affairs in Africa
29-30 Nov 2021 - Online webinar
Also on: 25 May 2022
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
13-15 Oct 2021 - Online webinar
Also on: 20 Apr 2022
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
24-25 Nov 2021 - Online webinar
Also on: 25 May 2022
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
3-4 Feb 2022 - Online webinar
Also on: 15 Aug 2022
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
15-16 Dec 2021 - Online webinar
Also on: 29 Jun 2022
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
14-15 Dec 2021 - Online webinar
Also on: 20 Jun 2022
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
Presented by Elinor McCartney (bio)
Regulatory Affairs for Support Staff
27-28 Sep 2021 - Online webinar
Also on: 28 Mar 2022
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
22 Sep 2021 - Online webinar
Also on: 16 Mar 2022
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Risk Management for Pharma and Biopharma Professionals
23 Sep 2021 - Online webinar
Also on: 29 Apr 2022
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
24-25 Nov 2021 - Online webinar
Also on: 25 May 2022
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
20-21 Sep 2021 - Online webinar
Also on: 21 Mar 2022
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
6-10 Dec 2021 - Online webinar
Also on: 13 Jun 2022
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
2-3 Nov 2021 - Online webinar
Also on: 16 May 2022
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
14-15 Oct 2021 - Online webinar
Also on: 26 Apr 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
6-7 Dec 2021 - Online webinar
Also on: 9 Jun 2022
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
20-24 Jun 2022 - Online webinar
Also on: 5 Dec 2022
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.