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Overview

Optimising the physical properties of an active pharmaceutical ingredient is a critical phase in the development of a drug candidate. Before the development of the final product, the physical and chemical properties of the API must be investigated. This workshop will look at the properties affecting a compound's synthesis, handling, stability, formulation and most critically its behaviour as a medicine. In addition, proven intellectual property protection strategies will be discussed with some examples.


Why should you attend this event?

  • Discover the most effective way of screening and selecting the best solid form of your API
  • Learn how to improve the stability and bioavailability of APIs
  • Understand how you can achieve more comprehensive intellectual property protection
  • Determine how you can save 12 months in the early stage clinical development
  • Explore intellectual property protection strategies

About the Masterclass Leaders

Linda McCausland, Head of Physical Sciences, Almac Group
Linda leads the group responsible for contract research, technology transfer and consultancy activities in the area of solid state chemistry and crystallisation process development at Almac. Linda has been working in this area for over 15 years and has extensive experience in solid form screening, selection and crystallisation. Linda is the inventor on several patents and has published numerous research papers in this area. Linda and her team develop technical knowledge in solid state chemistry and crystallization in order to speed up the drug development process.

Dr. Noel Hamill, Team Leader, Physical Sciences, Almac Group
With seven years in the pharmaceutical industry, Noel’s previous roles have encompassed technology transfer, process development, crystallisation science, physical organic chemistry and reaction engineering. Noel’s role in the Physical Sciences Group includes; crystallisation development, solid form screening and characterisation, method development and validation, staff training, consultancy, project management and hazard assessment. Noel acts as an adviser to clients on solid state issues (e.g. form selection, form control, scale-up, and interpretation of data) in the manufacture of drug substance and drug product.

Dr. Aeri Park, Director of US Operations, Almac Sciences.
Aeri has worked in the pharmaceutical industry for the past fifteen years, including eleven years at SSCI/Aptuit where she held the position of Research Director. Aeri is an organic chemist and a registered patent agent with USPTO, she received a Ph.D. in organic chemistry from the University of Oklahoma, with expertise in synthetic organic chemistry, separation and structure determination of natural products, nuclear magnetic resonance spectroscopy, crystallization technologies, and the analysis of pharmaceutical solids.  Aeri has served as a scientific consultant and expert witness to attorneys representing pharmaceutical companies involved in patent prosecution and infringement cases, and taught courses on solid state chemistry at European Patent Office (EPO) and United State Patent and Trademark Office (USPTO).
 

Masterclass programme

8:30 Registration & Coffee

9:00 Welcome and Introduction

Linda McCausland

Linda McCausland, Head of Physical Sciences, Almac Group

9:15 What is the most effective way of screening and selecting the best solid form?

Linda McCausland

Linda McCausland, Head of Physical Sciences, Almac Group

10:15 Coffee

10:30 Product rescue - Improving chemical and physical properties of an API

Noel Hamill

Noel Hamill, Team Leader, Physical Sciences, Almac Group

11:30 Achieve more comprehensive intellectual property protection

Linda McCausland

Linda McCausland, Head of Physical Sciences, Almac Group

12:30 Lunch

13:30 How well do you understand your crystallization process?

Noel Hamill

Noel Hamill, Team Leader, Physical Sciences, Almac Group

14:30 How to save 12 months in the early stages of clinical development

Linda McCausland

Linda McCausland, Head of Physical Sciences, Almac Group

15:30 Wrap up session, Q&A

16:00 Close of Masterclass

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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

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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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