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This workshop is led by PAREXEL, the leading pharma and healthcare consultancy in the US. 

The workshop will provide you with a greater insight regarding the regulatory requirements for analytical comparability versus similarity studies as well as how to properly select and justify analytical tools and how to interpret the results from analytical similarity studies, In addition to properly choosing the analytical methodologies and performing the studies, the workshop will discuss the important of understanding how to properly qualify the analytical characterization methods and how to manage the wealth of data to support you biologics license application and to properly prepare for an inspection in order to meet Quality Systems/GMP requirements. 

Topics include:

  • Distinctions between product comparability studies and similarity studies
  • Designing and conducting similarity studies- choosing appropriate product attributes, comparators, analytical tests and number of batches for similarity assessment
  • Addressing residual uncertainties in the analytical similarity programs
  • Assessing the Regulatory Quality Compliance Required for Biosimilars Approval
  • Quality systems/GMPs for biosimilar programs
  • Handling R&D analytical data for inspections
  • Documenting method qualification studies for similarity tests
     

Job titles include but are not restricted to: CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, from the following roles:
• Follow on Biologics/Follow on
Proteins/Biosimilars
• Biologics/Biotechnology/
Biogenerics
• Legal and Regulatory Affairs
• Intellectual Property
• Pricing and Reimbursement
• Clinical Immunology
• Process Control and Analytical Technologies
• Analytical Characterisation
• Regulatory Compliance
• Pharmacovigilance
• Drug Safety & Risk Management
• Quality Affairs/ Quality Control
• New Product Development
• Process Science
• Portfolio Management
• Research & Development
• Scientific Affairs
• Commercial Affairs & Strategic Planning

Workshop programme

8:30 Registration & Coffee

Ted Carver

Ted Carver, Principal Consultant, PAREXEL

Lotte McNamara

Lotte McNamara, Principal Consultant, PAREXEL

9:00 Workshop Leader's Opening Remarks

9:10 Evaluating How to Avoid Regulatory Pitfalls in Analytical Similarity Assessments

10:45 Morning Coffee

11:15 Assessing the Regulatory Quality Compliance Required for Biosimilars Approval

12:00 Discussion & Q&A

12:30 Close of Workshop

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Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

Renaissance Woodbridge Hotel

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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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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Opening Hours: 9.00 - 17.30 (local time)
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Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
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