Courses

Regulatory

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.

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 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

17-18 Mar 2020

Also on: 22 Sep 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

Book by 24 Oct to save
£100 / €140 / $156

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

4-5 Dec 2019

Also on: 2 Jun 2020

Book by 25 Oct to save
£200 / €280 / $312

The latest technologies in connected medical devices, digital health and mobile apps for the pharmaceutical and medical device industries

We can customise this course to meet your requirements.

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

Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.

Dry Powder Inhalers

24-25 Jun 2020

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

11 Feb 2020

Also on: 25 Sep 2020

Book by 20 Dec to save
£100 / €140 / $156

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

EU Pharmaceutical Regulations & Strategy

31 Oct-1 Nov 2019

Also on: 20 Apr 2020

Aquire key skills in maximising success in an expanding herbal product market

We can customise this course to meet your requirements.

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

2 Dec 2019

Also on: 25 Jun 2020

Book by 24 Oct to save
£100 / €140 / $156

This meeting 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

Book by 24 Oct to save
£100 / €140 / $156

An essential annual update for inhalation professionals. Industry case studies, regulatory updates, latest therapies and technology innovations.

Inhaled Drug Delivery

Bespoke training

We can customise this course to meet your requirements.

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

Injectable Drug Delivery

18-19 Mar 2020

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

19-20 Feb 2020

Also on: 16 Sep 2020

Book by 20 Dec to save
£200 / €280 / $312

This conference gives a comprehensive review within the field of nasal drug delivery while reviewing the very latest new data and innovative technologies.

Nasal Drug Delivery

14-15 May 2020

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

Pharmaceutical Development of ATMPs

30-31 Mar 2020

Also on: 5 Oct 2020

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation, technology, 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

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, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

Process Validation with Qualification

3-4 Mar 2020

Also on: 22 Sep 2020

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

19-20 Mar 2020

Also on: 29 Sep 2020

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learning how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Book by 25 Oct to save
£200 / €280 / $312

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

12-13 Mar 2020

Also on: 21 Sep 2020

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

2-3 Apr 2020

Also on: 8 Oct 2020