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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

8-9 Oct 2020

Also on: 20 Apr 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

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.

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

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

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.

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

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.

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.

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.

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

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

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

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.

Are you prepared and what next?

14.00 (GMT)

We can customise this course to meet your requirements.