Courses

Pharmaceutical

The pharmacovigilance legislation of 2012 requires companies to provide Risk Management Plans (RMPs) and assessments for all new products, whether generic products or new chemical entities.

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

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

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

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

7-9 Mar 2018

Also on: 24 Sep 2018

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.

An Essential Overview of Pharmacovigilance

30 Apr 2018

Also on: 12 Oct 2018

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 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 needing 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

25-26 Jan 2018

Also on: 9 Jul 2018

Book by 15 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

5-6 Dec 2017

Also on: 4 Jul 2018

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

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 practical guidance on Borderline issues and combination products

Dry Powder Inhalers, Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.

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

28 Feb 2018

Also on: 21 Sep 2018

Book by 12 Jan 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

23-24 Apr 2018

Also on: 30 Oct 2018

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

6 Dec 2017

Also on: 28 Jun 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

22-23 Mar 2018

Book by 12 Jan to save
£200 / €280 / $312

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

Leadership Skills for Pharmaceutical Professionals

21-22 Jun 2018

Also on: 26 Nov 2018

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 interesting new data and innovative technologies.

Nasal Drug Delivery

12-13 Apr 2018

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

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.

We can customise this course to meet your requirements.

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

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.

Book by 12 Jan 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.

A one-day programme which looks at the basic principles of Pharmacoepidemiology together with their practical application

Pharmacoepidemiology

22 Jun 2018

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

Pharmacovigilance

4-6 Dec 2017

Also on: 19 Jun 2018

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

Pharmacovigilance Aspects of Licensing Agreements

20 Feb 2018

Also on: 2 Oct 2018

Book by 12 Jan 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.

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

21 Mar 2018

Book by 12 Jan to save
£100 / €140 / $156

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

6-7 Mar 2018

Also on: 16 Oct 2018

Book by 12 Jan 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 role.

Regulatory Affairs for Support Staff

22-23 Feb 2018

Also on: 20 Sep 2018

Book by 12 Jan 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 in Clinical Research

26 Feb 2018

Also on: 24 Sep 2018

Book by 12 Jan 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

5-6 Dec 2017

Also on: 4 Jul 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 May 2018

Also on: 15 Oct 2018

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

22-23 Mar 2018

Also on: 13 Sep 2018

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.

We can customise this course to meet your requirements.

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.

The New ICH GCP E6 R2 Addendum

27 Feb 2018

Also on: 25 Sep 2018

Book by 12 Jan to save
£100 / €140 / $156

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.