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The global generic inhalation products market has already attracted the interest of many pharmaceutical companies, payers and regulators, and is likely to grow significantly in the future with many blockbuster products coming off patent. Designing a generic drug-device combination product such as an inhaler to fulfill the new FDA’s requirements whilst also staying clear off any IP infringement is challenging and requires a novel approach. This workshop is designed to explore the journey of designing a ‘new’ generic drug-device combination product.

This workshop will:
• Provide valuable insights into the development of a generic drug-device combination product from design perspective
• Explore how to design better and approvable generic products faster
• Provide insight into how to select the most appropriate platform device for a new generic product
• Assess a generic product against the new FDA’s requirements for submission purposes
 

People of all levels from these sectors should attend:
• Pharmaceutical companies
• Medical and combination product developers
• Design consultancies
• Human factors engineering
• Regulatory affairs

 

Workshop programme

13:30 Registration & Coffee

14:00 Opening remarks and introductions

Suresh Gupta

Suresh Gupta, Head of Human Factors and Usability Engineering, Cambridge Consultants
View Bio

14:10 Session 1 - Background overview

Suresh Gupta

Suresh Gupta, Head of Human Factors and Usability Engineering, Cambridge Consultants
View Bio

Provide background information such as what we mean by generic drug-device combination products, how they differ from other medical products, the different submission routes and their requirements, so that the participants can take active part in the subsequent discussion.
 

14:50 Session 2 - FDA’s new requirements for generic combination products

Suresh Gupta

Suresh Gupta, Head of Human Factors and Usability Engineering, Cambridge Consultants
View Bio

Distinguish the device constituent part of a generic combination product from the drug part and discuss the FDA’s new requirements for the device constituent part in detail, providing the foundation for the design for a ‘new’ generic combination product.

15:30 Afternoon Tea

16:00 Session 3 - Design of a generic combination product

Suresh Gupta

Suresh Gupta, Head of Human Factors and Usability Engineering, Cambridge Consultants
View Bio

Provide a framework for designing a ‘new’ generic combination product to fulfil the FDA’s requirements whilst also making it better than the innovator product where possible, and avoiding any IP infringement.

16:40 Session 4 - Discussion

Suresh Gupta

Suresh Gupta, Head of Human Factors and Usability Engineering, Cambridge Consultants
View Bio

• question and answer session

17:00 Chairman’s Closing Remarks and Close of Day One

Suresh Gupta

Suresh Gupta, Head of Human Factors and Usability Engineering, Cambridge Consultants
View Bio

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FEATURED SPEAKERS

Suresh Gupta

Suresh Gupta

Head of Human Factors and Usability Engineering, Cambridge Consultants

Suresh Gupta

Head of Human Factors and Usability Engineering, Cambridge Consultants
Suresh Gupta

Suresh is the Head of Human Factors and Usability Engineering at Cambridge Consultants, UK.


He has over fifteen years’ experience working within the medical device domain which includes eleven years’ of providing human factors expertise to the design and development of medical devices and combination products within a design consultancy environment. One of his specialisations is helping clients design generic and interchangeable biosimilar products.


He has been responsible for managing, planning and implementing of a wide range of human factors activities ranging from front-end user requirements capture through to preliminary analyses, formative and validation studies, and risk management. Suresh has a track record of delivering successful human factors and usability projects to pharmaceutical and medical technology companies worldwide.


He is also responsible for promoting human factors within medical product development, and growing the human factors capabilities and service offerings at Cambridge Consultants. Suresh has a PhD degree in engineering design, specialising in human factors, from Cambridge University.
 

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

HOTEL BOOKING FORM

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Copthorne Tara Hotel

Scarsdale Place
Kensington
London W8 5SR
United Kingdom

Copthorne Tara Hotel

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

HOTEL BOOKING FORM

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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