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Advancing biosimilars development and uptake in MENA and GCC regions
24 September 2019
Advancing biosimilars development and uptake in MENA and GCC regions

The need for biologics is critical in this region but the cost of these products are inhibiting uptake of biologics which is estimated at 2% of drugs used compared to 45% in the US. The workshop will highlight the challenges and address how we can support this region
 

Workshop LEADER

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Rodeina Challand

Executive Director, Project Management, Worldwide Clinical Trials, Challand Biosimilar Consulting

Science and Law Graduate with 30 years of experience in healthcare, cancer research, pharmaceutical industry and CRO, across a wide range of roles including developing and implementing clinical development strategies for biosimilars and complex generics. Experience in all aspects of biosimilar development including study design and regulatory agency discussions (EMA, FDA, MENA, GCC, Australia, India, Japan and S. Korea). In the last few years have worked with the developing regions and conducted several meetings with MENA and GCC Regulatory Agencies to educate and better understand their expectations licensing biosimilars; also supporting them in implementing clinical trial regulations and educating potential investigators in the region. Worked on over 15 biosimilar molecules across a range of products and indications, including ESAs, Filgrastims, Heparins, Insulins and monoclonal antibodies in various capacity including consulting, regulatory and clinical strategies, feasibility and supporting study delivery across all phase of development (phase I to IV).

Challand Biosimilar Consulting

Science and Law Graduate with 30 years of experience in healthcare, cancer research, pharmaceutical industry and CRO, across a wide range of roles including developing and implementing clinical development strategies for biosimilars and complex generics. Experience in all aspects of biosimilar development including study design and regulatory agency discussions (EMA, FDA, MENA, GCC, Australia, India, Japan and S. Korea). In the last few years have worked with the developing regions and conducted several meetings with MENA and GCC Regulatory Agencies to educate and better understand their expectations licensing biosimilars; also supporting them in implementing clinical trial regulations and educating potential investigators in the region. Worked on over 15 biosimilar molecules across a range of products and indications, including ESAs, Filgrastims, Heparins, Insulins and monoclonal antibodies in various capacity including consulting, regulatory and clinical strategies, feasibility and supporting study delivery across all phase of development (phase I to IV).

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, SAE Media 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@saemediagroup.com

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Contact SAE Media Group

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smgconferences.com Email: events@saemediagroup.com
Registered in England - SMi Group Ltd trading as SAE Media Group




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