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Pharmaceutical companies embody application of the scientific method to identify and deliver new patient therapies in an environment that increasingly relies on outsourcing much of the R&D and production of HPAPIs. The same systematic, scientific principles should be used to develop and deliver research, development and production facilities that are fit for purpose and protect healthy workers. This workshop will explore key steps in rolling out an HPAPI program while partnering with a CDMO, helping to define and deliver HPAPI projects that are technically sound, based on justifiable data which can underpin robust and defensible investment.

· Learn key HPAPI project elements
· Understand key drivers from an innovator and CDMO perspective
· Assess what factors are important and how to build information designed to underpin HPAPI project investments
· Providing a pathway to systematic and scientific project design
 

API specialists, Containment Engineers, Senior Scientists, Head of Scale-up Processings, Occupational Health Officers, Industrial Hygiene Leads, Head of Bioconjugations, Pharmaceutical Company Directors,Preclinical Safety Experts, Biopharmaceutical Developers, Industrial Hygienist, Industrial Hygienist Consultants, Occupational Toxicologists, Occupational Health Experts, Pharamaceutical Company Presidents and Vice Presidents, Head of Toxicology, Process Chemists, Process Research & Develpoment, Head of Technology Transfer
 

AbbVie; Accord Healthcare; ACRAF S.P.A; ADC Biotechnology; ADC Biotechnology Ltd; Affygility Solutions; Antikor Biopharma; ARCINOVA; Astrazenecaá; Bayer Pharma; BSP Pharmaceuticals S.p.A.; CARBOGEN AMCIS AG; Cortex Consultancy; Cristalia Produtos Quimicos Farmaceuticos; Dec Group; Dishman Europe Limited; DSTL; Egis Pharmaceuticals PLC; Ferring Pharmaceuticals; Ferring Pharmaceuticals A/S; Gedeon Richter Plc.; Genentech; GlaxoSmithKline; Glythera; HPAPI Project Services Limited; Ipsen; Merck; Merck Group; Merck Serono GmbH; MINAKEM SAS; Nicomac Europe; Oncogen Pharma; Oril Industrie; Roche Pharma Research & Early Development; SafeBridge Consultants, Inc; SafeBridge Europe Ltd; SK Biotek; Skyepharma S A; Swish Tech Limited; The University of Edinburgh
 

Workshop programme

8:00 Registration & Coffee

8:45 The Innovator CDMO/CMO Relationship for potent compounds

Janet Gould

Janet Gould, Principal Toxicologist, SafeBridge Consultants Inc
View Bio

Charlyn Reihman

Charlyn Reihman, Principal Occupational Health Consultant, SafeBridge Europe Ltd
View Bio

9:45 Hazard assessment

Janet Gould

Janet Gould, Principal Toxicologist, SafeBridge Consultants Inc
View Bio

Charlyn Reihman

Charlyn Reihman, Principal Occupational Health Consultant, SafeBridge Europe Ltd
View Bio

10:30 Morning Coffee

10:50 Facility Features and General Controls

Janet Gould

Janet Gould, Principal Toxicologist, SafeBridge Consultants Inc
View Bio

Charlyn Reihman

Charlyn Reihman, Principal Occupational Health Consultant, SafeBridge Europe Ltd
View Bio

11:20 Control and Containment

Janet Gould

Janet Gould, Principal Toxicologist, SafeBridge Consultants Inc
View Bio

Charlyn Reihman

Charlyn Reihman, Principal Occupational Health Consultant, SafeBridge Europe Ltd
View Bio

11:40 Verification of control/containment performance

Janet Gould

Janet Gould, Principal Toxicologist, SafeBridge Consultants Inc
View Bio

Charlyn Reihman

Charlyn Reihman, Principal Occupational Health Consultant, SafeBridge Europe Ltd
View Bio

12:00 Other Program Elements

Janet Gould

Janet Gould, Principal Toxicologist, SafeBridge Consultants Inc
View Bio

Charlyn Reihman

Charlyn Reihman, Principal Occupational Health Consultant, SafeBridge Europe Ltd
View Bio

12:10 Typing it all together

Janet Gould

Janet Gould, Principal Toxicologist, SafeBridge Consultants Inc
View Bio

12:30 Workshop leaders’ closing remarks

Janet Gould

Janet Gould, Principal Toxicologist, SafeBridge Consultants Inc
View Bio

Charlyn Reihman

Charlyn Reihman, Principal Occupational Health Consultant, SafeBridge Europe Ltd
View Bio

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Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Sheraton Boston Hotel

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

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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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