About the Speaker:

Luciano Gambini began his career as an analyst in R&D. He moved into Validation and Quality Assurance for the Pharmaceutical Development Department of Farmitalia Carlo Erba. At Pharmacia, later Pharmacia and Upjohn, he spent his working life in global R&D Quality Assurance setting up the internal policies for the quality of Investigational Medicinal Products (IMPs). He is currently the coordinator of the AFI (Italian Association of Industrial Pharmacists) working group on manufacture of IMPs. The meeting will be chaired, and the subject introduced by Irene Gonzalez-Conde, Board Member of AEFI (Spanish Association of Industrial Pharmacists).

Overview of Webinar:

From the 31st January 2022 the “new” Clinical Trial Regulation 536/14 and its reference documents for IMP manufacture will enter into force. The following are some of the questions arising:

  • Is this a big cultural change for people involved in IMP manufacture?
  • How do the interactions between GMP and GCP evolve?
  • How much should the Quality System for IMP manufacture be updated?
  • What are the critical differences between GMPs for IMPs and those for the commercial pharmaceutical products and which are their interactions?
  • Do the responsibilities for the Sponsor and the Qualified Person remain the same?
  • Particularly important for IMPs, are the labelling requirements the same?

The aim of the webinar is to provide initial answers to these questions, highlighting the differences between the current and new regulations and to propose possible solutions to cover the gaps between the old and new scenario.

Learning Outcomes:

By the end of this webinar, you will be able to:

  1. Understand the difference between the set of documents applicable under the EU Directive 2001/20 and those applicable under Regulation 536/14.
  2. Comprehend how to update the quality system to be in compliance with the new scenario.
  3. Allow the Sponsor to be aware of the new scenario in order to speed up the approval of the clinical trial.
  4. Give the QPs the tools to certify the batch of IMP according to the new set of guidelines.

Registration:

Please register for the event by filling out the Webinar Registration Form in the event flyer EIPG PIER IMP Manufacturing in Era of Clinical Trial 536/14 webinar. The instructions will be shown on the screen when you submit the form, for you to keep a record of them.

Continuing Education:

A certificate of attendance will be issued after the webinar. The session will be an hour of Continuing Education.

The PIER Committee is organising a virtual career info 'Exploring Alternate Career Options' event on Thursday evening 11th November 2021 (7.30pm-8.30pm). This event will feature a mixed panel of pharmacists working in alternate careers related to healthcare or the life sciences. 

  • Dr Evin Allen (MSD Brinny)
  • Avril Byrne (Optum)
  • Catherine Mulhall (Sanofi Consumer UK)
  • Anita Nolan (Department of Health)
  • Dr Kieran Walsh (HIQA)

The event will be chaired by Rosemarie Tully (Avadel & PIER)

Register for the event using the QR code in the event flyer PIER 'Exploring Alternate Career Options'_11th Nov 2021

The PIER Committee is organising a virtual career information event 'Strategies for Successful Career Change' on Thursday 30th September 2021 (7.00pm-9.00pm). This event are a great opportunity for students, interns or patient facing pharmacists to get advice about job hunting and to hear from a panel of pharmacists who have made a career change in recent years (representing AstraZeneca, HPRA, Medisource, Novartis, Pfizer and Servier).

PIER members & non-members welcome to attend this particular event. 

PIER career info event agenda 30th Sept 2021

See event flyer for further information PIER 'Strategies for Successful Career Change' virtual event flyer_30th Sept 2021.

Register via https://docs.google.com/forms/d/1Tod1O341yAxGBxZU06lhRfKctA_YZJyJ0Lz9UmizfO4/edit

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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.

 

Learning Outcomes:

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.

 

Continuing Education:

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.

https://us06web.zoom.us/j/96609087487?pwd=a1YzcnBIYmRDZHNvYkdRdVZ4M3RRQT09

Meeting ID: 966 0908 7487

Passcode: 031907

Pharmacist Dr. Kate O'Reilly (Senior Digital Health Consultant at HealthXL) will present a high level overview of 'Digital Health' via Zoom on Thursday 1st July 2021 (1.00pm-2.00pm). Topics to be covered include:
  • Digital Therapeutics
  • Remote Patient Monitoring
  • Clinical Decision Support Solutions
  • Telemedicine
  • Connected Drug Delivery
  • Use cases in CTs &R&D
  • Data Analytics
  • Opportunities for pharma
  • Predictions
 
 
The PIER Committee is organising a series of lunchtime speed networking events on the last Friday of the month. The first one is being organised on Friday 25th June 2021 (1.00pm-2.00pm) via Zoom.
Great opportunity to meet new people. PIER members and non-members welcome. 
 

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:

  • Introduction to the site: Kieran Coffey (Technical Services Lead)
  • Panel disscusion with some of the pharmacists working on-site in areas including Quality and Tech Ops. 

Register via: https://docs.google.com/forms/d/1Qcn2PFP3VQl-ACEyy75XteQ0tdI9b9Cb_1xVxHiAfEk/prefill

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:

  • Dr Fergus Sweeney, Head of the Clinical Studies and Manufacturing Task Force at the EMA covering the Clinical Trial Information System, Biological Health Threats and Vaccine Strategy
  • Dr Derek O’Hagan, Global Head of Vaccine Chemistry and Formulation, GSK Vaccine Research, Cambridge, MA.
  • Professor Mahendra G. Patel, Pharmacy and Ethnic Minority Communities Research Lead and Co-Investigator, PRINCIPLE Trial, University of Oxford
  • Dr Oksana Pyzik, Lead of UCL Global Citizenship Programme, Global Health Adviser, UCL School of Pharmacy

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'

 ATMPs EIPG EPSA

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

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