Courses

Regulatory

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

Book by 4 Oct to save
£200 / €280 / $312

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 2019

Also on: 13 May 2020

Book by 4 Oct to save
£300 / €420 / $468

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.

Biological Evaluation of Medical Devices

31 Oct-1 Nov 2019

Also on: 27 May 2020

Book by 6 Sep to save
£200 / €280 / $312

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

Book by 4 Oct to save
£200 / €280 / $312

The latest technologies in connected medical devices, digital health and mobile apps for the pharmaceutical and medical device industries

Book by 23 Aug to save
£200 / €280 / $312

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Book by 4 Oct to save
£200 / €280 / $312

Practical Guidance on Borderline Issues and Combination Products

Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.

Dry Powder Inhalers

Bespoke training

We can customise this course to meet your requirements.

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

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.

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

An essential annual update for inhalation professionals. Industry case studies, regulatory updates, latest therapies and technology innovations.

Inhaled Drug Delivery

6-7 Nov 2019

Book by 23 Aug to save
£200 / €280 / $312

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

Injectable Drug Delivery

18-19 Mar 2020

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.

Book by 4 Oct 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

We can customise this course to meet your requirements.

This seminar will provide essential guidance on how to undertake a successful conformity assessment process and subsequently apply (or continue to apply) the CE mark

PLEASE NOTE THE ORIGINAL DATE FOR THIS EVENT HAS CHANGED TO 8-9 MAY 2019

Book by 6 Sep to save
£200 / €280 / $312

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 approvals for Medical Devices in Latin America. Countries to be covered: Brazil, Mexico, Colombia and Peru

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

Book by 4 Oct to save
£300 / €420 / $468

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

Medical Device Studies: Clinical Evidence

14-15 Nov 2019

Also on: 11 May 2020

Book by 4 Oct to save
£200 / €280 / $312

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

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

Metered Dose Inhaler (MDI) Technology

18-19 Sep 2019

Also on: 19 Feb 2020

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

14-15 May 2020

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

24-25 Sep 2019

Also on: 4 Mar 2020

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.