Recent Developments in Quality By Design Of Pharmaceutical Products


    This one day seminar will introduce participants to the latest thinking on medicinal product development using a series of lectures and hands-on exercises delivered by experienced scientists and thought-leaders with hands on experience of developing and launching medicinal products.

    Drug development is often focussed on proving the safety and efficacy of new drugs with less attention given to the development of the product. However it is the product that the patient actually receives, the regulatory authorities approve, the physician prescribes and the payers reimburse. Thus, without due consideration throughout development for the design of the product and its subsequent manufacturing process there is a real risk that a medicine will not fulfil its potential and won’t reach the market.

    The approaches described will be underpinned by Quality by Design concepts and will be mainly focussed on the development of oral dosage forms, although also applicable to other routes of delivery. The hands on exercises are designed to increase the understanding of the delegates and provide good access to the presenters.

    Quality by Design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines (EMA). Quality by design starts by pre-defining criteria for drug product quality, with a view to maximising the likelihood that the product will deliver the desired benefits. Starting with the end in mind and applying a more structured and systematic approach to development has the potential to reduce development times, minimise wasted effort and most importantly increase the probability of meeting patient need. By applying the principles of quality by design, scientists and engineers in development can ensure that all sources of variability affecting a manufacturing process and the subsequent quality of the product are identified, explained and managed by appropriate measures. This ‘right first time’ approach to development enables the finished medicine to consistently meet its predefined characteristics ensuring that the patient always receives product of the right quality.

    This course is suitable for pharmaceutical scientists new to the field as well as those wishing to build on and broaden their knowledge of Quality by Design in real life development. The course will also be valuable for project leaders and managers in drug discovery and biotech organisations, involved in developing the next generation of new medicines. The seminar will provide key insights into this often neglected aspect of drug development.

    Agenda

    08:30 – 09:05:  Registration and Coffee

    09:05 – 09:25:  Introduction: The context of the QbD initiative and its impact on product development

    Dr. Marcel de Matas, Product Design Director, Seda Pharmaceutical Development Services

    09:25 – 10:00:  Physiological understanding of drug absorption and its relationship to product design and testing:

    1. Principles of drug absorption

    2. Pharmacokinetics and drug activity

    3. Impact of formulation performance on pharmacokinetics

    Dr. Paul Dickinson, Product Performance Director, Seda Pharmaceutical Development Services

    10:00 – 10:25:  Defining the quality target product profile – patient centric product design:

    1. Disease and patient insight

    2. ICH Q8 and QTPP

    3. Critical Quality Attributes

    Dr. Marcel de Matas, Product Design Director, Seda Pharmaceutical Development Services

    10:25 – 10:50:  QTPP thinking in early Development:

    1. Preformulation and biopharmaceutics data required

    2. How to deal with QTPP prior to FTiM

    Dr Claire Patterson, Associate Principal Scientist Biopharmaceutics, AstraZeneca

    10:50 – 11:20:  Coffee Break

    11:20 – 12:00:  Hands on exercise: defining the QTPP

    Dr Claire Patterson, Associate Principal Scientist Biopharmaceutics, AstraZeneca and Dr. Marcel de Matas, Product Design Director, Seda Pharmaceutical Development Services and speaker

    12:00 – 12:50:  Lunch

    12:50 – 13:35:  Product/Process design and understanding:

    1. Quality risk assessment (QRA)

    2. Identifying Critical Process Parameters

    3. Advances in manufacturing, modeling and process analytical technology to enhance process understanding

    Prof Gavin Reynolds Principal Scientist, Process Engineering, AstraZeneca

    13.35 – 14.05: Hands on exercise: QRA and what that would mean for an experimental program

    Prof Gavin Reynolds Principal Scientist, Process Engineering, AstraZeneca and Marcel de Matas, Product Design Director, Seda Pharmaceutical Development Services

    14.05 – 14.45: Specifications in a QbD development including clinically relevant specifications:

    1. Clinically relevant dissolution testing

    2. Setting specifications

    Dr Paul Dickinson, Product Performance Director, Seda Pharmaceutical Development Services

    14.45 – 15.15: Coffee Break

    15.15 – 16.05: Writing the regulatory submission:

    1. The importance of the control strategy vs Design Space and how it fits into the common technical document

    2. The implications for process variability: moving from development to commercial manufacture

    Dr Dave Holt, Principal Scientist, Statistical Process Control, AstraZeneca

    16.05 – 16.55: Hand on exercise: defining the control strategy

    Dr Dave Holt, Principal Scientist, Statistical Process Control, AstraZeneca and Dr Marcel de Matas, Product Design Director, Seda Pharmaceutical Services

    16.55 – 17.00: Concluding comments

    Delegate Fee

    £175.00 + VAT

    Please note that there are student places available at the event at a discounted rate of £150.00 + VAT. These places are however limited and registration can be made by emailing Helen Williams at helen.williams@bionow.co.uk.

    Exhibition Stands

    3m x 2m space

    One delegate pass

    Recognition as an exhibitor on event web page and link to company website

    Price: £300.00 + VAT

    To reserve an exhibition space or for further details, please emailhelen.williams@bionow.co.uk.

    Organisers: Alderley Park Limited

    T: +44 1625 628600

    Email: Martin.mochan@mspl.co.uk

    URL: http://www.bionow.co.uk/events/recentdevelopmentsinqualitybydesignofpharma.aspx

    Organiser: Recent Developments in Quality By Design Of Pharmaceutical Products


    This one day seminar will introduce participants to the latest thinking on medicinal product development using a series of lectures and hands-on exercises delivered by experienced scientists and thought-leaders with hands on experience of developing and launching medicinal products.

    Drug development is often focussed on proving the safety and efficacy of new drugs with less attention given to the development of the product. However it is the product that the patient actually receives, the regulatory authorities approve, the physician prescribes and the payers reimburse. Thus, without due consideration throughout development for the design of the product and its subsequent manufacturing process there is a real risk that a medicine will not fulfil its potential and won’t reach the market.

    The approaches described will be underpinned by Quality by Design concepts and will be mainly focussed on the development of oral dosage forms, although also applicable to other routes of delivery. The hands on exercises are designed to increase the understanding of the delegates and provide good access to the presenters.

    Quality by Design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines (EMA). Quality by design starts by pre-defining criteria for drug product quality, with a view to maximising the likelihood that the product will deliver the desired benefits. Starting with the end in mind and applying a more structured and systematic approach to development has the potential to reduce development times, minimise wasted effort and most importantly increase the probability of meeting patient need. By applying the principles of quality by design, scientists and engineers in development can ensure that all sources of variability affecting a manufacturing process and the subsequent quality of the product are identified, explained and managed by appropriate measures. This 'right first time' approach to development enables the finished medicine to consistently meet its predefined characteristics ensuring that the patient always receives product of the right quality.

    This course is suitable for pharmaceutical scientists new to the field as well as those wishing to build on and broaden their knowledge of Quality by Design in real life development. The course will also be valuable for project leaders and managers in drug discovery and biotech organisations, involved in developing the next generation of new medicines. The seminar will provide key insights into this often neglected aspect of drug development.

    Agenda

    08:30 - 09:05:  Registration and Coffee

    09:05 - 09:25:  Introduction: The context of the QbD initiative and its impact on product development

    Dr. Marcel de Matas, Product Design Director, Seda Pharmaceutical Development Services

    09:25 - 10:00:  Physiological understanding of drug absorption and its relationship to product design and testing:

    1. Principles of drug absorption

    2. Pharmacokinetics and drug activity

    3. Impact of formulation performance on pharmacokinetics

    Dr. Paul Dickinson, Product Performance Director, Seda Pharmaceutical Development Services

    10:00 - 10:25:  Defining the quality target product profile – patient centric product design:

    1. Disease and patient insight

    2. ICH Q8 and QTPP

    3. Critical Quality Attributes

    Dr. Marcel de Matas, Product Design Director, Seda Pharmaceutical Development Services

    10:25 - 10:50:  QTPP thinking in early Development:

    1. Preformulation and biopharmaceutics data required

    2. How to deal with QTPP prior to FTiM

    Dr Claire Patterson, Associate Principal Scientist Biopharmaceutics, AstraZeneca

    10:50 - 11:20:  Coffee Break

    11:20 - 12:00:  Hands on exercise: defining the QTPP

    Dr Claire Patterson, Associate Principal Scientist Biopharmaceutics, AstraZeneca and Dr. Marcel de Matas, Product Design Director, Seda Pharmaceutical Development Services and speaker

    12:00 - 12:50:  Lunch

    12:50 - 13:35:  Product/Process design and understanding:

    1. Quality risk assessment (QRA)

    2. Identifying Critical Process Parameters

    3. Advances in manufacturing, modeling and process analytical technology to enhance process understanding

    Prof Gavin Reynolds Principal Scientist, Process Engineering, AstraZeneca

    13.35 - 14.05: Hands on exercise: QRA and what that would mean for an experimental program

    Prof Gavin Reynolds Principal Scientist, Process Engineering, AstraZeneca and Marcel de Matas, Product Design Director, Seda Pharmaceutical Development Services

    14.05 - 14.45: Specifications in a QbD development including clinically relevant specifications:

    1. Clinically relevant dissolution testing

    2. Setting specifications

    Dr Paul Dickinson, Product Performance Director, Seda Pharmaceutical Development Services

    14.45 - 15.15: Coffee Break

    15.15 - 16.05: Writing the regulatory submission:

    1. The importance of the control strategy vs Design Space and how it fits into the common technical document

    2. The implications for process variability: moving from development to commercial manufacture

    Dr Dave Holt, Principal Scientist, Statistical Process Control, AstraZeneca

    16.05 - 16.55: Hand on exercise: defining the control strategy

    Dr Dave Holt, Principal Scientist, Statistical Process Control, AstraZeneca and Dr Marcel de Matas, Product Design Director, Seda Pharmaceutical Services

    16.55 - 17.00: Concluding comments

    Delegate Fee

    £175.00 + VAT

    Please note that there are student places available at the event at a discounted rate of £150.00 + VAT. These places are however limited and registration can be made by emailing Helen Williams at helen.williams@bionow.co.uk.

    Exhibition Stands

    3m x 2m space

    One delegate pass

    Recognition as an exhibitor on event web page and link to company website

    Price: £300.00 + VAT

    To reserve an exhibition space or for further details, please emailhelen.williams@bionow.co.uk.

    Organisers: Alderley Park Limited

    T: +44 1625 628600

    Email: Martin.mochan@mspl.co.uk

    URL: http://www.bionow.co.uk/events/recentdevelopmentsinqualitybydesignofpharma.aspx