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The SMi Group is pleased to invite you to the 5th Annual Lyophilization USA Conference arranged to take place on the 23rd and 24th October 2019, in Boston.
The current list of FDA-approved biopharmaceuticals contains up to 50% of injectables and approximately a third of all parenterals being lyophilized, which suggests it is the optimal way of ensuring stability in products that are unstable in aqueous solution. This instability or degradation can result in suboptimal product performance and even toxicity in worst cases indicating the need for lyophilization despite it’s inherently expensive running costs and time-consuming process.
However, despite being a relatively old process, there is much need for improvements to circumvent the high costs and extended process times with much room for innovation. Next year’s projections for the lyophilization equipment market are approximately $5.7 billion, which is 8% CAGR. This surge is fuelled by the urge to perfect lyophilization processes in areas that characterise the product to better inform formulation and process developments while consequently improving efficiency and reducing capital investment.
Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of lyophilization. Benchmark and network with industry leaders and discuss the most up to date and relevant topics that delve into alternative lyophilization approaches, applied statistical modelling, fresh views on scaling up and tech transfer, pre- and post-product characterization. regulation and beyond.
 


 Participating in this year’s SMi Group Lyophilisation USA 2019 conference provides a chance to connect with research and industry leaders with the aim of tackling the most pressing hurdles in multiple areas of interest within lyophilisation:
- Gain valuable insight into the most current challenges and considerations when working with highly concentrated and sensitive formulations
- Explore new and innovative approaches in model-based studies that utilise the power of statistical analysis to improve process development and understanding
- Discuss the future outlook of lyophilization through trends in alternative approaches
- Discover updates on the leading PAT technologies such as controlled nucleation, continuous freeze drying, low-frequency Raman, vacuum-foam drying and more.
- Listen to key opinion leaders and experts from regulatory bodies speak about expectations and the assessment of reliable technologies in the market
 

VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:
• Lyophilization/Freeze-drying
• Formulation Scientists
• Principal Scientist
• Process Development/Engineer
• Sterile/Fill-Finish
• Production
• PAT
• CMC
• Chemistry
• Manufacturing
• Quality Assurance/QA

Amatisgroup; Arlenda; Aznil Telstar Technologies, SLU; Abbott Healthcare Products BVá; BioNTech; Baxter SA; Bayer A G; Biofire Diagnostics; Biopharma Group; BioPharma Technology; Boehringer Ingelheim; Boehringer-Ingelheim; Bristol-Myers Squibb; BSP PHARMACEUTICALS Srl; BUCHI UK Ltd ; DeMontford University; DSM; Ferring Pharmaceuticals A/S; Fresnius Kabi Austria GmbH; F. Hoffman-La Roche Ltd.; GEA Process Engineering; Genzyme Ireland Ltd; GlaxoSmithKline; GlaxoSmithKline plc; GSK; GSK Manufacturing S.p.A.; Hosokawa Micron BV; Imperial College London; LFB Technology; INDATECH SAS; Janssen Pharmaceutica NV; MedImmune; MedImmune Inc.; Merck KGaA; Mylan; NIBSC; Novo Nordisk; OPTIMA pharma GmbH; Pacifi Ltd; Pfizer Inc; Pliva Croatia Ltd; RheaVita BV; Roche; Roche Pharmaceuticals; Sandoz GmbH; Syngenta Limited; TEVA Pharmaceuticals; University College Cork (UCC); University Of Central Lancashire; University of Ghent; Vetoquinol SA; Xellia Pharmaceuticals ApS;
 

VENUE

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Boston, USA

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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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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