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.
An Essential Overview of the Medical Device Industry Training Course
12 Oct 2020 - Online webinar
Also on: 13 May 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 Training Course
23 Oct 2020 - Online webinar
Also on: 26 Oct 2020
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
An Introduction to Pharmaceutical Packaging Training Course
22-23 Sep 2020 - Online webinar
Also on: 15 Mar 2021
This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.
Borderlines between Medicines and Food Training Course
10 Dec 2020 - London
Also on: 11 Dec 2020
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
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course
30 Mar 2021 - Online webinar
Also on: 31 Mar 2021
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)
Common Technical Document Training Course
Cyber Security for Medical Devices Training Course
Development of Combination Products: Critical Interactions Training Course
17-18 Nov 2020 - Online webinar
Also on: 5 May 2021
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course
22-23 Sep 2020 - London
Also on: 24 Sep 2020
Practical guidance on borderline Issues and combination products
Dry Powder Inhalers Training Course
Effective Technical Writing & Editing Training Course
EU (European Union) Pharmaceutical Regulations & Strategy Training Course
Filing eCTD Submissions Training Course
How to Write Effective SOPs (Standard Operating Procedures) Training Course
3 Dec 2020 - Online webinar
Also on: 28 Jun 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.
Improving Processes and CAPA (Corrective and Preventative Action) Training Course
4 Dec 2020 - Online webinar
Also on: 29 Jun 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.
Inhaled Drug Delivery Training Course
Injectable Drug Delivery Training Course
Metered Dose Inhaler (MDI) Technology Training Course
Nasal Drug Delivery Training Course
Pharmaceutical Development of ATMPs Training Course
Pharmaceutical Packaging, Labelling and Artwork Origination Training Course
28-29 Oct 2020 - London
Also on: 27 Oct 2021
This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.
Pharmaceutical Regulatory Affairs in Africa Training Course
12-13 Oct 2020 - Online webinar
Also on: 22 Mar 2021
Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe and French-speaking Africa
Pharmaceutical Regulatory Affairs in Asia Training Course
7-9 Apr 2021 - Online webinar
Also on: 14 Apr 2021
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 Training Course
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course
2-3 Feb 2021 - London
Also on: 4 Feb 2021
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Pharmaceutical Regulatory Affairs in the Middle East Training Course
28-29 Jun 2021 - Online webinar
Also on: 5 Jul 2021
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Process Validation with Qualification Training Course
22-23 Sep 2020 - Online webinar
Also on: 2 Mar 2021
Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.
Regulatory Affairs for Support Staff Training Course
29-30 Sep 2020 - Online webinar
Also on: 16 Mar 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.
Regulatory Strategies for Orphan Drugs Training Course
Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course
2-3 Dec 2020 - Online webinar
Also on: 6 Jul 2021
Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
The FDA (Food and Drug Administration) Drug Approval Process Training Course
Variations to Marketing Authorisations Training Course
8-9 Oct 2020 - Online webinar
Also on: 25 Mar 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.