Courses

Pharmaceutical

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.

Book by 21 Dec to save
£100 / €140 / $156

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

Book by 21 Dec to save
£100 / €140 / $156

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

Advanced Pharmacovigilance

25-27 Mar 2019

Also on: 25 Sep 2019

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

20-21 Mar 2019

Also on: 25 Sep 2019

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

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

24-25 Jan 2019

Also on: 8 Jul 2019

Book by 21 Dec to save
£200 / €280 / $312

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 Dec 2018

Also on: 3 Jul 2019

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.

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

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

Dry Powder Inhalers

19-20 Jun 2019

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

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

15 Feb 2019

Also on: 24 Sep 2019

Book by 21 Dec 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

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

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

Exploring Routes to Market for Herbals

16 Nov 2018

Also on: 9 May 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

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

3 Dec 2018

Also on: 27 Jun 2019

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

Bespoke training

We can customise this course to meet your requirements.

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

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

Leadership Skills for Pharmaceutical Professionals

26-27 Nov 2018

Also on: 30 Oct 2019

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

Leading & Developing Successful Pharma Teams

19-20 Nov 2018

Also on: 18 Nov 2019

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

8-9 Apr 2019

Also on: 3 Oct 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

4-5 Apr 2019

Also on: 7 Oct 2019

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

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

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

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.

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

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

We can customise this course to meet your requirements.

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

Pharmacovigilance

3-5 Dec 2018

Also on: 24 Jun 2019

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.

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

This course is designed to help in both the assessments of risk and the whole CAPA and preventative action elements.

Pharmacovigilance QMS & Inspection Preparation

22-23 Nov 2018

Also on: 9 May 2019

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

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

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

6-7 Dec 2018

Also on: 1 Jul 2019

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

14-15 Mar 2019

Also on: 23 Sep 2019

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

28 Mar 2019

Also on: 23 Sep 2019

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

Signal Detection and Regulatory Expectations

26-27 Nov 2018

Also on: 23 May 2019

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 Dec 2018

Also on: 3 Jul 2019

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.

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.

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

21-22 Mar 2019

Also on: 19 Sep 2019

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.

We can customise this course to meet your requirements.

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: 14 May 2019