Our latest COVID-19 information/status - including self-paced online learning from our training partner Falconbury

Training & Courses:
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.

 

Our spring/summer 2020 programme of London-based courses has been cancelled due to the COVID-19 outbreak. We are taking bookings for our Autumn events, but we are also working to deliver courses and content online. Please contact us if you are interested in an on-site or online version of any of our courses, tailored to your company's needs.

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 Medical Device Industry

12 Oct 2020

Also on: 13 May 2021

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

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.

An Introduction to Pharmaceutical Packaging

22-23 Sep 2020

Also on: 17 Mar 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

Borderlines between Medicines and Food

11 Dec 2020

Also on: 10 Dec 2021

Brexit Update – What will happen next?
14.15 (GMT)

We can customise this course to meet your requirements.

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)

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Common Technical Document

1-2 Dec 2020

Also on: 2 Jun 2021

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Practical guidance on borderline Issues and combination products

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

FULLY UPDATED PROGRAMME

Dry Powder Inhalers

23-24 Jun 2021

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Effective Technical Writing & Editing

24 Sep 2020

Also on: 11 Feb 2021

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations

EU Pharmaceutical Regulations & Strategy

22-23 Oct 2020

Also on: 19 Apr 2021

Acquire key skills to maximise success in an expanding herbal product market.

We can customise this course to meet your requirements.

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Filing eCTD Submissions

6 Oct 2020

Also on: 12 Apr 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.

How to Write Effective SOPs

3 Dec 2020

Also on: 28 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.

An essential annual update for inhalation professionals.

Inhaled Drug Delivery

3-4 Nov 2020

Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.

Injectable Drug Delivery

10-11 Mar 2021

Understand the impact of IP on pharmaceutical regulatory strategy

We can customise this course to meet your requirements.

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Metered Dose Inhaler (MDI) Technology

16-17 Sep 2020

Also on: 16 Feb 2021

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Nasal Drug Delivery

15-16 Apr 2021

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Pharmaceutical Development of ATMPs

5-6 Oct 2020

Also on: 22 Mar 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.

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 Africa

12-13 Oct 2020

Also on: 22 Mar 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

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

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.

Process Validation with Qualification

22-23 Sep 2020

Also on: 2 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 Affairs for Support Staff

29-30 Sep 2020

Also on: 18 Mar 2021

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Regulatory Strategies for Orphan Drugs

23 Sep 2020

Also on: 10 Mar 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.

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

The FDA Drug Approval Process

21-22 Sep 2020

Also on: 11 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.

Variations to Marketing Authorisations

8-9 Oct 2020

Also on: 25 Mar 2021

I was hoping to get a better insight into writing reports and I would say that I definitely believe this was accomplished.

Neil McCann, Radiation Safety Officer, Elekta Limited

Barbara was technically brilliant and presented in a fun, challenging and friendly way. The content through the day was very useful, with good pointers and tips to improve the layout and quality of documents. The course structure and content was excellent, a good amount for a day's course. The presentation was fantastic and easy to follow with good exercises and interaction between presenter and course participants. Barbara has a deep knowledge of the subject matter which is delivered in an exciting way.

Nathan Entwistle, Senior Electronics Technician, Team Consulting

Very good course with plenty of personal interaction. The experience of the speaker gives added value as she can provide many examples and tips and tricks for reviewing a text.

Anke De Muylder, Quality engineer QA, Plasma Industries Belgium

Excellent presentation by a first-class speaker who has a wealth of knowledge. I particularly liked the interactive exercises.

Wil Pantin, New Product Introduction Manager, M & A Pharmachem Ltd

Overall the course content was very good. Presentation was also good and very clear. The speaker was excellent and very active during the training.

Ildephonse Ngabonziza, Clinical Safety Manager, Genae Associates NV

A well set out webinar with plenty of time for questions.

Jenny Lakin, Head of Product Registration, Torbay Pharmaceuticals

A well thought through presentation about a topic that is in flux which gave the current state of play.

David Rose, Medical Quality Expert, Koura

A really good and useful course. The speakers are obviously experts in their fields and are very good at communicating their knowledge.

Miriam Ferrer, Head of New Product Development, Cambridge Nutraceuticals

Very worthwhile course with a great mix of experts.

Stephanie Ward, Marketing Executive, Cambridge Nutraceuticals

A good course.

Konstantina Karagkika, Technical Manager, Innocent Drinks