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.
Bespoke training
We can customise this course to meet your requirements.
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.
Book by 12 Apr to save
£100 / €140 / $156
This course provides an essential overview and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience
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.
Book by 22 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.
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
New course for 2018
5-6 Jun 2019
Also on: 26 Nov 2019
Understanding connected medical devices, medical mobile Apps and the Medical Device Internet of Things
9-10 Oct 2019
Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.
Practical Guidance on Borderline Issues and Combination Products
Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.
19-20 Jun 2019
Book by 9 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
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
24 Sep 2019
The ‘how to’ of technology transfer across the product lifecycle
New for 2018
Book by 9 Apr to save
£200 / €280 / $312
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
Book by 10 May to save
£100 / €140 / $156
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
Hear the latest information from our expert speaker panel to help you understand the changes that are required and ensure you are up to date with Brexit!
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
Book by 10 May to save
£100 / €140 / $156
This annual conference will include case studies, regulatory updates, latest therapies and technology innovations in two information packed days
6-7 Nov 2019
Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.
28-29 Mar 2019
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 22 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
Bespoke training
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
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
Book by 18 Feb to save
£200 / €280 / $312
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
8-9 May 2019
Also on: 29 Oct 2019
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.
Bespoke training
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
16 Sep 2019
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.
Book by 3 May to save
£200 / €280 / $312
An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management
29-30 Apr 2019
Also on: 20 Nov 2019
Book by 22 Mar to save
£200 / €280 / $312
Gatherine and using clincal evidence for CE marking and post-market compliance in line with the new MDR
Book by 22 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
2-3 Apr 2019
Also on: 1 Oct 2019
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.
11-12 Apr 2019
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.
Advances in wearable drug delivery, this conference will review the current trends in the market and highlight the latest technology in this fast growing area.
Bespoke training
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.
27 Mar 2019
This leading project management course will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills
Book by 10 May to save
£200 / €280 / $312
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.
Book by 12 Apr to save
£300 / €420 / $468
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 3 May to save
£500 / €700 / $780
A three-day accelerated management programme, designed specifically for pharmaceutical/ biotechnology professionals and also applicable to medical device/animal health industries, to give you the high-performance management skills of an MBA
Book by 15 Mar to save
£300 / €420 / $468