Overview of Webinar:
Over the last 20 years Physiologically - Based Pharmacokinetic (PBPK) Modelling and Simulation has developed and is now used extensively within Discovery and Development in the Pharmaceutical Industry. Its adoption has been driven by the availability of commercial software platforms and a realisation of the benefits to be gained including the potential to reduce the number of in vivo studies performed.This webinar will cover an introduction to PBPK modelling, what it is and how it can be applied to support Chemistry, Manufacturing and Controls (CMC) development.It will provide an overview of usage in oral, small molecule development, supported by examples from the areas of biopharmaceutics and formulation development. Current and potential future applications of PBPK modelling in Quality and Regulatory fields will also be discussed.
By the end of this webinar, you will be able to:
1. Understand the definition of a Physiologically - Based Pharmacokinetic (PBPK) model.
2. Demonstrate an awareness of how PBPK models can be used.
3. Appreciate the benefits and challenges in applying PBPK models in CMC areas.
About the Speaker:
Dr Jonathan Brown graduated in Pharmacy from University of Nottingham and is a registered UK pharmacist. He gained a PhD in Drug Delivery from the University of Manchester and subsequently joined Bristol-Myers Squibb. He has worked on the development of solid oral dosage forms and also in CMC project team leadership for over 20 years. He has worked extensively in the design of extended release systems and has strong understanding and experience of PBPK modelling of oral formulations. He is a co-founder of the Gastroplus User Group and has contributed to several academic-industrial consortia in the area of paediatric formulation and biopharmaceutics.
To Join the Webinar
Please register for the event by filling out the Webinar Registration Form in the event flyer EIPG PIER 'Physiologically-based PK modelling and simulation webinar'. The access instructions will be shown on the screen when you submit the form, for you to keep a record of them.
A certificate of attendance will be issued after the webinar. The session will be an hour of Continuing Education.
Please join us for lunchtime speednetworking on Friday 30th July 2021 from 1.00pm.
Meeting ID: 966 0908 7487
European Medicines Registration Consultancy (EMRC) is an established pharmaceutical consultancy company based in Ashbourne offering an extensive range of regulatory affairs and compliance services to both Irish and international pharmaceutical companies, wholesalers and manufacturers.
A vacancy currently exists for an experienced Regulatory Affairs professional to undertake standard tasks including the following:
This role is flexible and can be tailored to suit the candidate’s circumstances i.e. full-time or part-time, short or long term, office based or work from home. The successful candidate would have a minimum of 3 years experience in regulatory, quality or compliance with a pharmaceutical company and would be familiar with HPRA and Irish regulatory requirements.
Please forward enquiries or declaration of interest to: Eimear O'Reilly at email@example.com.
Posted: 10th July 2021
The PIER Committee is delighted to organise its first virtual site vist to the Pfizer Newbridge manufacturing site. It is one of Europe’s largest manufacturers of solid-dose pharmaceuticals. The facility currently supplies a largre range of products across a number of therapeutic areas: including cardiovascular, central nervous system and women's health to more than 100 markets across the world.
The virtual visit will take the following format:
Webex details will be provided closer to the date.
EIPG are organising a mini-Symposium 'The Post-COVID Era and Pharmacy' on Friday 18th June 2021 at 1.30pm BST (2.30pm CEST).
The event will allow EIPG members to consider the lessons learned from the Covid-19 pandemic: the repurposing of medicines for treatment, vaccines development, clinical trials design update, agility in drug development and regulatory flexibility.
It will be a great opportunity to hear and put your questions to the following speakers:
The discussion about how pharmacists can shape the future in a post-COVID era will be chaired by Professor Gino Martino, Chief Scientist (Royal Pharmaceutical Society).
The Symposium is free for all members of EIPG Associations and will last for just over 2 hours. Please register via link in this event flyer EIPG 'Post-Covid Era Symposium_18th June 2021',
GSK currently have an exciting opportunity for a Quality Assistant (based at Citywest, Dublin) on a full-time basis for an 18-month fixed term contract. This position is to help support the Trading Partner Quality Team in the worldwide virtual wholesale distribution operations of GSK’s Pharma Trading Partner companies. It is a great opportunity to obtain a strong grounding experience of Good Distribution Practice (GDP) and the QMS (Quality Management Systems) in a virtual wholesale distributor.
Posted 24th May 2021
A joint webinar with the European Pharmaceutical Students’ Association and EIPG is being held this Thursday 20th May 2021 at 17.00 GMT on “Understanding Advanced Therapies”.
SCOPE: The background to advanced therapies will be discussed including gene therapy, cell therapy, and tissue engineering. Examples will be shown of how advanced therapies are dramatically changing the way patients are treated for a wide variety of diseases. A discussion will be held on the role of pharmacists and their ability to advise patients about these products which have such huge potential for the future of medicine.
SPEAKER: Sunayana Shah is an expert in regulatory, medical, and pharmacovigilance policy development as well as technical, scientific, and regulatory intelligence at global level including working with WHO, European and UK organisations. Sunayana worked at the Association of the British Pharmaceutical Industry (ABPI), London, where, as Head of Regulatory and Safety Policy she advised the pharmaceutical industry and worked with senior UK and EU government officials on international regulatory policy issues, including the impact of Brexit. Previously, she led the scientific and medical affairs function at the Proprietary Association of Great Britain (PAGB) where she developed and implemented national and pan European and global OTC reclassification policy, regulatory expertise, and led the Professional Learning training programmes. Sunayana is a registered pharmacist and EIPG’s delegate for Great Britain. She is a consultant and recently co-authored a toolkit on cell and gene therapy for the International Alliance of Patient Organisations and IFPMA.
REGISTRATION: There is no registration for this webinar.
Free access is via the link: Zoom Meeting https://zoom.us/j/93920028291?pwd=WEI1NGlhZktrV3JaeEF3Q1U0eGx0dz09
Meeting ID: 939 2002 8291 Passcode: 576982