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Medical Devices

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

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

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Advanced Regulatory Affairs for Medical Devices

8-9 Oct 2020

Also on: 20 Apr 2021

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

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

An Introduction to the Medical Device Regulation

11-13 Nov 2020

Also on: 12 May 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.

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

Includes: Interactive workshops and discussion sessions

Biological Evaluation of Medical Devices

25-26 Nov 2020

Also on: 18 May 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

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

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

This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.

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 seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the ‘general controls’ applicable to all devices.

FDA Approval Process for Medical Devices

16-17 Sep 2020

Also on: 24 Mar 2021

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

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

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

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971 ‘Application to Risk Management to Medical Devices’.

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

Gain practical advice on how regulations are being applied to enable you to take full advantage of this rapidly growing market.

We can customise this course to meet your requirements.

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

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

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Medical Device Studies: Clinical Evidence

9-10 Nov 2020

Also on: 10 May 2021

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

How to produce quality regulatory documents including the clinical evaluation report (CER)

Medical Writing for Medical Devices

30 Sep-1 Oct 2020

Also on: 3 Mar 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

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

New Medical Device Regulation

19-20 Oct 2020

Also on: 17 Mar 2021

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

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.

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.

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

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

FULLY UPDATED PROGRAMME

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

Technical Documentation to Comply with the MDR and IVDR

29-30 Sep 2020

Also on: 10 Mar 2021

A practical five-day course with interactive workshops – now in its 17th successful year!

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

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

Are you prepared and what next?

14.00 (GMT)

We can customise this course to meet your requirements.

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.