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 10 May to save
£100 / €140 / $156

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

Book by 10 May 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

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.

An Essential Overview of the Medical Device Industry

21 May 2019

Also on: 14 Oct 2019

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

25-26 Sep 2019

Also on: 17 Mar 2020

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 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

Brexit Update – What will happen next?
25 March 2019 – 2pm (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 two-day course that will ensure you to comply with new regulatory requirements

Clinical Quality Management Systems

23-24 May 2019

Also on: 14 Nov 2019

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

8-9 Jul 2019

Also on: 30 Jan 2020

Book by 10 May to save
£200 / €280 / $312

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

Common Technical Document

3-4 Jul 2019

Also on: 4 Dec 2019

Book by 10 May to save
£200 / €280 / $312

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.

Book by 31 May to save
£100 / €140 / $156

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

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

New for 2019

Effective Technology Transfer

21-22 May 2019

Also on: 19 Nov 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.

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

We can customise this course to meet your requirements.

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

This one hour webinar will help you understand what has the impact of GDPR been on drug development
25 February 2019 – 2pm (GMT)

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

27 Jun 2019

Also on: 2 Dec 2019

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

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!

We can customise this course to meet your requirements.

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 10 May to save
£100 / €140 / $156

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

Inhaled Drug Delivery

6-7 Nov 2019

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

Injectable Drug Delivery

Bespoke training

We can customise this course to meet your requirements.

Understand the impact of IP on pharmaceutical regulatory strategy

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

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

Bespoke training

We can customise this course to meet your requirements.

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

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

We can customise this course to meet your requirements.

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

We can customise this course to meet your requirements.

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

Book by 10 May to save
£200 / €280 / $312

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

24-26 Jun 2019

Also on: 2 Dec 2019

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

This course will provide you with practical advice in preparing an effective audit report, to ensure your readers understand the findings and the key messages you are trying to convey. Examples of common issues and pitfalls will be discussed to enable you to improve your audit writing skills.

We can customise this course to meet your requirements.

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 understand pharmacovigilance Quality Management Systems (QMS) and risk based audits

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

Powerful Negotiation Skills

Bespoke training

We can customise this course to meet your requirements.

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

Bespoke training

We can customise this course to meet your requirements.

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

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

1-2 Jul 2019

Also on: 9 Dec 2019

Book by 10 May to save
£200 / €280 / $312

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.

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

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

23-24 May 2019

Also on: 25 Nov 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

3-4 Jul 2019

Also on: 4 Dec 2019

Book by 10 May to save
£200 / €280 / $312

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

21-23 May 2019

Also on: 14 Oct 2019

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.

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

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

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.

A three-day accelerated management programme, designed specifically for pharmaceutical/ biotechnology professionals and also applicable to medical device/animal health industries, to give you the high-performance management skills of an MBA

The Pharma Mini MBA

14-16 May 2019

Also on: 4 Nov 2019