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Programme

The event series is split over 6 separate dates with the next one 2nd March 2021.

20th April/18th May/15th & 29th June

A series of virtual webinars has been organised by the Academy of Pharmaceutical Sciences Biopharmaceutics Focus Group. They will run from January to May, with speakers including Industry, Academia and Regulatory colleagues, with opportunities for questions and discussions. A summary of a previous workshop organised by APS can be found at: https://doi.org/10.3390/pharmaceutics12010019

(Meeting Report: Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives, Pharmaceutics 2020, 12(1), 19, McAllister et al.)

The sessions will include

  • Introduction to CRDS – the “what” and “why”
  • Introduction to PBPK/PBBM Modelling – the “what” and “how”
  • How to develop CRDS including case studies from Industry
  • Overview of global regulatory trends within CRDS including progress, challenges and emerging opportunities
  • Future developments with PBBM/PBPK software packages
  • Emerging opportunities within PBPK/PBBM modelling to support CRDS including new research areas

Six webinars will run January, March, April, May, June

They will start at 2pm and run for 60-90 mins depending on the topic. Each session will have at least 2 speakers. There will be an opportunity for Q&A in each webinar.

You can register for one seminar or all 5.

You will be sent a ZOOM INVITE a day before the event and then one hour before the start. Please click to join.

The webinar series will be of relevance to Industry, Regulators, specialist technology providers Private Sector and Academic colleagues.  The aim is to share and discuss progress and challenges through scientific presentations and Q&A sessions. The webinars will cover the current state of scientific affairs in the field, emerging trends and identify areas where Industry and regulators can engage to further harmonise and enable CRDS development moving forwards.

Claire Mackie (Janssen), Andreas Abend (MSD), Mark McAllister (Pfizer), Sue Cole (MHRA), Victor Mangas (University of Valencia),
Evangelos Kotzagiorgis (EMA), Heather Mead (AZ), Talia Flanagan (UCB), Jobst Limberg (BfArM), Johannes Kraemer (Dissolution Science)

2nd Event; 2nd March 2021-Introduction to PBPK/PBBM. The How and the Why.

“Clinically Relevant Dissolution Specifications – Why, What, and How ?”

Speakers: Dr Paul Dickinson – SEDA Pharmaceutical Development Services and Dr Andreas Abend – MSD

Developing and registering clinically relevant dissolution specifications has been the subject of much discussion and debate for formulation, analytical and regulatory scientists for several years. Recent workshops and literature which have focused on the topic suggest certainly progress and evolution in the area as industry and regulators learn from working “hands on’ with CRDS, however some work remains to reach an agreed scientific framework to routinely establish such specifications for oral immediate-release (IR) drug products and to realise its full potential.

This webinar will set the stage for our seminar series and cover:

  • The principles and benefits of clinically relevant specifications
  • Highlight the progress in the area over the last few years including Regulatory and Industry scientific meeting outputs
  • A cross Industry perspective and recommended roadmap on approaches for establishing CRDS for IR oral drug products.

Dr Paul Dickinson – SEDA Pharmaceutical Development Services

Paul A Dickinson BPharm (Hons) PhD
Director, Seda Pharmaceutical Development Services®

Paul is co-founder of Seda, a company providing pharmaceutical development and clinical pharmacology services and consultancy to the Pharma Industry.
Published in The Times and referenced in FDA draft guidance, Paul has held several senior science leadership roles in Academia and Large Pharma for over 20 years. These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pre-clinical, pharmaceutical and clinical disciplines.
Paul has extensive early development, late development and drug registration stage experience including the delivery of several products to approval.
Paul has an international scientific reputation and is past Chair of the AAPS ‘QbD and product performance’ focus group. Paul has been at the forefront of recent technical and regulatory advances in performance criteria that assure drug product performance in the patient (clinically relevant specifications).

Dr Andreas Abend – MSD

Andreas Abend received his PhD degree in Organic Chemistry from the University of Karlsruhe in Germany. Prior to joining MSD as a Senior Project Chemist, Andreas spent 3 years as a Post-Doctoral Fellow at the University of Wisconsin’s Enzyme Institute. He is currently a Director in the Analytical Sciences department leading a group of scientists supporting new drug product development. Throughout his career at MSD, he supported small molecule API and drug product development spanning all clinical phases. Andreas is a member of Merck’s Biopharmaceutical Advisory Team, PQRI’s BTC, and a member of IQ’s Analytical Leadership Group. He presented at many national and international meetings, published several manuscripts on Clinically Relevant Dissolution specifications and he recently served as co-organizer of two workshops at the Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

3rd Event; 20th April 2021-How to develop CRDS including case studies from Industry

4th Event; 18th May 2021-Overview of global regulatory trends within CRDS including progress, challenges and emerging opportunities

5th Event; 15th June 2021-• Future developments with PBBM/PBPK software packages

6th Event; 29th June 2021-Emerging opportunities within PBPK/PBBM modelling to support CRDS including new research areas

1st Event; 19th January 2021-Clinically Relevant Dissolution specifications: Why, What, and How?

March webinar programme – Introduction to PBPK/PBBM. The How and the Why.

Speakers: Dr Andrea Moir- AstraZeneca and Dr Susan Cole – MHRA

PBPK/ PBBM Modelling is increasingly used by Industry to set CRDS and models have been used and accepted in regulatory submissions. There are a number of different approaches to model dissolution within the Industry. As an introduction to examples which will be presented in subsequent webinars, the approach to developing and building a model will be described. Best practices in model building will be considered with regulatory thoughts on assessing predictive performance and qualification of models and with reflection on the relevant guidelines.

This webinar will set the stage for our seminar series and cover:
• Background to PBPK/PBBM
• How to model dissolution (PSD approach, PBDT approach)
• Best practices in PBPK approaches to modelling and model evaluation for CRDS
• Introduction to examples and link to next webinars

Dr Andrea Moir- AstraZeneca

Dr Susan Cole – MHRA

Event information

APS MEMBERS FREE FOR ALL WEBINARS IN THE SERIES

Non-Members

Students and Early careers- £10 per webinar & £30 to attend all 6 webinars

Others- £20 per webinar and £60 to attend all 6 webinars

All prices ex VAT

Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Non-Members - Students and Early Careers (single webinar)
£ 10.00
Unlimited
Non-Members - Others (single webinar)
£ 20.00
Unlimited
Non-Members - Students and Early Careers (six webinars)
£ 30.00
Unlimited
Non-Members - Others (six webinars)
£ 60.00
Unlimited
Members (Code available from Members Hub for FREE access)
£ 20.00
Unlimited