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.

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

Advanced Regulatory Affairs for Medical Devices

26-27 Mar 2020

Also on: 8 Oct 2020

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

Book by 10 Apr 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

13-15 May 2020

Also on: 11 Nov 2020

Book by 20 Mar 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.

Includes: Interactive workshops and discussion sessions

Biological Evaluation of Medical Devices

18-19 May 2020

Also on: 25 Nov 2020

Book by 10 Apr to save
£200 / €280 / $312

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

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

Book by 10 Apr 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 20 Mar to save
£200 / €280 / $312

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

24-25 Jun 2020

Book by 10 Apr to save
£200 / €280 / $312

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

We can customise this course to meet your requirements.

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

31 Mar-1 Apr 2020

Also on: 22 Sep 2020

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.

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

Inhaled Drug Delivery

Bespoke training

We can customise this course to meet your requirements.

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 20 Mar 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

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.

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

Book by 10 Apr to save
£200 / €280 / $312

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

Book by 20 Mar 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

11-12 May 2020

Also on: 9 Nov 2020

Book by 20 Mar 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

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

Book by 3 Apr to save
£200 / €280 / $312

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.

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.

Book by 10 Apr to save
£500 / €700 / $780

Are you prepared and what next?

14.00 (GMT)