This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.

Understand RMPs relationship to safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance

Abridged Applications, The Regulator and the Industry view, an intensive course examing the current requirements and current problems for those with a basic knowledge of the application procedure.

Abridged Applications

Bespoke training

We can customise this course to meet your requirements.

This course will be of maximum benefit to those safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing

Advanced Pharmacovigilance

24-26 Sep 2018

Also on: 25 Mar 2019

Book by 15 Aug to save
£300 / €420 / $468

Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.

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 a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience

An Introduction to Pharmaceutical Packaging

26-27 Sep 2018

Also on: 20 Mar 2019

Book by 15 Aug to save
£200 / €280 / $312

An insight into the FDA thinking of which products qualify for a Risk Evaluation and Mitigation Strategies (REMS), the different categories of REMS, their introduction and maintenance and the reporting assessments on the REMS.

An introduction and overview of the main principles and concepts of Pharmacokinetics relating to drug discovery and development.

We can customise this course to meet your requirements.

Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology

Biotechnology for the Non-Biotechnologist

26-28 Sep 2018

Also on: 10 Apr 2019

Book by 10 Aug to save
£300 / €420 / $468

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

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

Clinical Trial Regulatory Requirements

9-10 Jul 2018

Also on: 24 Jan 2019

Gain a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories also covered.

Common Technical Document

4-5 Jul 2018

Also on: 4 Dec 2018

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Data Integrity for GxP Compliance

21 Sep 2018

Also on: 11 Mar 2019

Book by 26 Jul to save
£100 / €140 / $156

Some of the topics to be covered at this meeting include overview of the legal/policy landscape as it affects the terms of CTAs, clause by clause review, legal clauses, review of a Universitys CTA

We can customise this course to meet your requirements.

A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors

Practical Guidance on Borderline Issues and Combination Products

Book by 24 Aug to save
£200 / €280 / $312

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

We can customise this course to meet your requirements.

A concise one-day seminar about the key principles of delegation, its link to motivation and impact on productivity.

Effective Delegation Skills

Bespoke training

We can customise this course to meet your requirements.

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

21 Sep 2018

Also on: 15 Feb 2019

Book by 26 Jul to save
£100 / €140 / $156

The ‘how to’ of technology transfer across the product lifecycle

New for 2018

Effective Technology Transfer

12-13 Nov 2018

Also on: 21 May 2019

Book by 5 Oct to save
£200 / €280 / $312

Interactive course ideal for anyone with responsibility for planning or delivering training in the Pharma, Device or Animal Health Industries (including GXP and SOP training to comply with EU and FDA inspection requirements).

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

EU Pharmaceutical Regulations & Strategy

30-31 Oct 2018

Also on: 29 Apr 2019

This course provides an update on recent changes to rICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

Book by 26 Jul to save
£100 / €140 / $156

This webinar on the GDPR will help you understand how it will apply to clinical trials with a 1 hour presentation at 2pm (BST), followed by a discussion session

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

28 Jun 2018

Also on: 3 Dec 2018

Hear the latest information from our expert speaker panel to help you understand the changes that are required and ensure you are up to date with Brexit!

Brand new course for 2018

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

This annual conference will include case studies, regulatory updates, latest therapies and technology innovations in two information packed days

Inhaled Drug Delivery

1-2 Nov 2018

The essential conference for pharmaceutical and medical device professionals covering advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods – plus a regulatory update

Injectable Drug Delivery

21-22 Mar 2019

Understand the impact of IP on pharmaceutical regulatory strategy

Brand new course for 2018

Covering Latest Developments and Hot Topics – consolidate your understanding of the issues that challenge companies in the current regulatory environment

We can customise this course to meet your requirements.

This comprehensive two day course will introduce you to the core concepts of what makes an excellent leader – in the context of the pharmaceutical industry – and how to apply the different skills of leading your staff and team to maximise results

Creating a team that speaks and acts with one vision in the pharma/device/animal health industries

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R & D projects you need to outsource.

Managing Vendor/CRO/CMO Oversight

4-5 Oct 2018

Also on: 8 Apr 2019

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

Nasal Drug Delivery

11-12 Apr 2019

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

Pharmaceutical Development of ATMPs

2-3 Oct 2018

Also on: 4 Apr 2019

Book by 17 Aug to save
£200 / €280 / $312

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.

Pharmaceutical Regulatory Affairs in Africa including South Africa, Algeria ,Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Nigeria, Namibia, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe

Book by 17 Aug to save
£200 / €280 / $312

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

We can customise this course to meet your requirements.

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong Macau and Taiwan.

Pharmaceutical Regulatory Affairs in Latin America a comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharma Industry in key Latin Americal countries

We can customise this course to meet your requirements.

This interactive meeting will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation, which came into force in 2016.

We can customise this course to meet your requirements.

This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in Drug safety.


3-5 Dec 2018

This course will provide examples of common issues/pitfalls and will enable you to improve your audit report writing skills, and therefore, give you more confidence in creating effective reports via which your audit outputs can be communicated to your stakeholders.

Pharmacovigilance / GCP Audit Report Writing

14 Sep 2018

Also on: 5 Mar 2019

Book by 26 Jul to save
£100 / €140 / $156

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Pharmacovigilance Aspects of Licensing Agreements

2 Oct 2018

Also on: 2 Apr 2019

Book by 10 Aug to save
£100 / €140 / $156

This two-day workshop is for those new to negotiations or for those who wish to refresh and/or enhance their existing negotiation skills.

Book by 15 Aug to save
£200 / €280 / $312

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Pre-Filled Syringes

20 Mar 2019

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

16-17 Oct 2018

Also on: 6 Mar 2019

Book by 17 Aug to save
£200 / €280 / $312

This leading project management course will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills

Project Management for Pharma Professionals

2-3 Jul 2018

Also on: 6 Dec 2018

This two day course which has been designed specifically for those working in a support staff role provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development.

Regulatory Affairs for Support Staff

20-21 Sep 2018

Also on: 14 Mar 2019

Book by 26 Jul to save
£200 / €280 / $312

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

Risk Management for Clinical Research

24 Sep 2018

Also on: 28 Mar 2019

Book by 15 Aug to save
£100 / €140 / $156

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

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.

Stability Testing of Pharmaceuticals

4-5 Jul 2018

Also on: 4 Dec 2018

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard.

Successful Medical Writing

15-17 Oct 2018

Also on: 22 May 2019

Book by 15 Aug to save
£300 / €420 / $468

There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application.

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

We can customise this course to meet your requirements.

General introduction and important information on FDA Procedures requirements for marketing authorizations and recent developments affecting the drug approval process in the US

The FDA Drug Approval Process

13-14 Sep 2018

Also on: 21 Mar 2019

Book by 26 Jul to save
£200 / €280 / $312

This seminar will enable you to meet the new international GCP ICH GCP E6 standard to enable the acceptance of clinical trial data by the regulatory authorities internationally including the European Union, Japan, the United States, Canada and Switzerland.

This 3-day accelerated management programme will provide you with practical management tools to apply in the workplace, as well as giving a real taste of an MBA course with pharma case studies from business schools.

The Pharma Mini MBA

5-7 Nov 2018

Also on: 13 May 2019

Variations to Marketing Authorisations in the EU, review of the Variations regulations. Update on Mutual Recognition/Decentralised, Centralised and National Variations (with emphasis on UK and Ireland).

We can customise this course to meet your requirements.