Courses

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.

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 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

14-16 May 2018

Also on: 12 Nov 2018

Understanding connected medical devices, medical mobile Apps and the Medical Device Internet of Things

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.

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

Book by 22 Dec to save
£200 / €280 / $312

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 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.

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 one-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

Book by 22 Dec to save
£100 / €140 / $156

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

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

ISO 13485: Quality Management Systems for Medical Devices

20-21 Feb 2018

Also on: 19 Sep 2018

Book by 22 Dec to save
£200 / €280 / $312

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.

Medical Device Regulations in Asia-Pacific markets, gain practical advice on how regulations are being applied to enable you to maximise on 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.

An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management

This seminar has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products.

Medical Device Studies: Clinical Evidence

29-30 Nov 2017

Also on: 16 May 2018

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

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

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

26-27 Feb 2018

Also on: 25 Sep 2018

Book by 22 Dec to save
£200 / €280 / $312

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

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

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 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.

Technology advances in insulin pumps, transdermal patches, micro needle patches and patch pumps

Wearable Drug Delivery

Bespoke training

We can customise this course to meet your requirements.