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Pharmaceutical

A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.

This specially designed four-day seminar running in Dubai has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

This specialist five-day seminar running in Dubai has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

5-day International Commercial Contracts School, Dubai

20-24 Sep 2020

Also on: 3 Oct 2021

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

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

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

23-25 Sep 2020

Also on: 17 Mar 2021

A practical guide to understanding the role of pharmacovigilance.

An Essential Overview of Pharmacovigilance

5 Oct 2020

Also on: 26 Apr 2021

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

12 Oct 2020

Also on: 13 May 2021

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 of pharmaceutical packaging 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

22-23 Sep 2020

Also on: 17 Mar 2021

Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Biosimilars

6-7 Oct 2020

Also on: 23 Mar 2021

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Biotechnology for the Non-Biotechnologist

30 Sep-2 Oct 2020

Also on: 14 Apr 2021

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

Borderlines between Medicines and Food

11 Dec 2020

Also on: 10 Dec 2021

Brexit Update – What will happen next?
14.15 (GMT)

We can customise this course to meet your requirements.

A two-day no-nonsense plain English practical course to get to grips with business and contract law for busy business executives.

Business and Contract Law

3-4 Dec 2020

Also on: 9 Mar 2021

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 comply with new regulatory requirements.

Clinical Quality Management Systems

19-20 Nov 2020

Also on: 17 May 2021

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

28-29 Jan 2021

Also on: 5 Jul 2021

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

Common Technical Document

1-2 Dec 2020

Also on: 2 Jun 2021

Conflict is an inevitable part of life. This interactive seminar will help provide added skills for when conflict has arisen and there is a need to build confidence and de-escalate the confrontation

We can customise this course to meet your requirements.

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

Data Integrity and Document Management

5 Oct 2020

Also on: 5 Mar 2021

During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.

We can customise this course to meet your requirements.

A two-day course for those looking to improve their decision-making and problem-solving skills within the pharma industry. Also suitable for the biotech, medical device and animal health industries.

Fully updated programme!

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.

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Drafting and Negotiating Clinical Trial Agreements

3 Nov 2020

Also on: 10 Jun 2021

Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
INCLUDES: Practical and interactive exercises

A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.

Drafting Commercial Contracts

28-29 Oct 2020

Also on: 22 Feb 2021

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

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

Drafting International Commercial Agreements in English

11-13 Nov 2020

Also on: 24 Mar 2021

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.

Practical guidance on borderline Issues and combination products

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

FULLY UPDATED PROGRAMME

Dry Powder Inhalers

23-24 Jun 2021

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

24 Sep 2020

Also on: 11 Feb 2021

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

Effective Technology Transfer

1-2 Oct 2020

Also on: 20 Apr 2021

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).

We can customise this course to meet your requirements.

This practical and interactive two-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.

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

EU Clinical Trial Regulation: Overview and Implementation

19-20 Oct 2020

Also on: 22 Apr 2021

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

EU Pharmaceutical Regulations & Strategy

22-23 Oct 2020

Also on: 19 Apr 2021

Acquire key skills to maximise success in an expanding herbal product market.

We can customise this course to meet your requirements.

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Filing eCTD Submissions

6 Oct 2020

Also on: 12 Apr 2021

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 the impact of GDPR has been on drug development
25 February 2019 – 2pm (GMT)

We can customise this course to meet your requirements.

Understand the importance of accuracy and attention to detail in day-to-day work

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 2020

Also on: 28 Jun 2021

This course 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.

A two-day workshop for those who need to achieve results through personal influence.
BOOK EARLY – limited places available!

An essential annual update for inhalation professionals.

Inhaled Drug Delivery

3-4 Nov 2020

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

Injectable Drug Delivery

10-11 Mar 2021

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

Leadership Skills for Pharmaceutical Professionals

17-18 Sep 2020

Also on: 12 Apr 2021

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

We can customise this course to meet your requirements.

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Two practical days to understand current best practice and generate creative, value-added solutions to your management challenges.

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 Oct 2020

Also on: 26 Apr 2021

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Metered Dose Inhaler (MDI) Technology

16-17 Sep 2020

Also on: 16 Feb 2021

This interactive one-day course will provide an introduction to mindfulness and encourage new ways of thinking and working, as well as help you relate to stress and problems in a different way.

Mindfulness in the Workplace

Bespoke training

We can customise this course to meet your requirements.

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Nasal Drug Delivery

15-16 Apr 2021

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

Negotiating and Drafting IT Contracts

8-9 Sep 2020

Also on: 9 Mar 2021

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

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

Pharmaceutical Development of ATMPs

5-6 Oct 2020

Also on: 22 Mar 2021

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

Pharmaceutical Regulatory Affairs in Africa

12-13 Oct 2020

Also on: 22 Mar 2021

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

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

Pharmacovigilance

7-9 Dec 2020

Also on: 21 Jun 2021

This course will provide you with practical advice on 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

Pharmacovigilance Aspects of Licensing Agreements

9 Oct 2020

Also on: 15 Apr 2021

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

Pharmacovigilance QMS & Inspection Preparation

19-20 Nov 2020

Also on: 13 May 2021

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

NEW COURSE!

This two-day course will challenge your current thinking and behaviour in all areas of communication.
 
 
 

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.

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Process Validation with Qualification

22-23 Sep 2020

Also on: 2 Mar 2021

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

Includes: Interactive workshop sessions

Project Management for Pharma Professionals

10-11 Dec 2020

Also on: 17 Jun 2021

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

29-30 Sep 2020

Also on: 18 Mar 2021

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Regulatory Strategies for Orphan Drugs

23 Sep 2020

Also on: 10 Mar 2021

Providing key legal and commercial skills essential to secure a successful agreement.

FULLY UPDATED PROGRAMME

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 Sep 2020

Also on: 22 Mar 2021

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

2-3 Nov 2020

Also on: 3 May 2021

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

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

5-7 Oct 2020

Also on: 24 May 2021

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

21-22 Sep 2020

Also on: 11 Mar 2021

Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department

The Mini MBA for In-house Lawyers

24-27 Nov 2020

Also on: 22 Jun 2021

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

The Pharma Mini MBA

11-13 Nov 2020

Also on: 12 May 2021

Getting from contract agreement to successful contract completion.

Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.

NEW EVENT!

The Role and Responsibilities of the Contracts Manager

26-27 Nov 2020

Also on: 17 Jun 2021

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

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

8-9 Oct 2020

Also on: 25 Mar 2021

Communicate, influence and motivate to enhance internal and external relationships and help improve the performance of you and your business.

We can customise this course to meet your requirements.