EIPG is organising a webinar on the European Directorate for the Quality of Medicines & HealthCare (EDQM) inspection programme to be held on Tuesday 10th December 2019 at 4pm.

Dr. Sotirios Paraschos, one of the EDQM Inspectors, will present on the EDQM role within the European regulatory framework, including its function within EU legislation of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs). The webinar will introduce the EDQM inspection programme and its relevance to CEPs, preparation, performance and follow-up of the inspections. In addition, there will be a review of the frequent types of issues observed during EDQM inspections.

Please register via the following link: http://newbusinessmedia.mn-ssl.com/nl/link?d=2nov&h=2rvs5585bsp71dvji0sjb65v6c&i=3og&iw=5&n=1aac&p=H301800627&s=wv&sl=ita&sn=1aac.

Attendance is free of charge for PIER members.

For further information on EDQM, see https://www.edqm.eu/.

The PIER 2019 Autumn CPD meeting & AGM will take place on Sat 23rd November 2019 in Clayton Liffey Valley, Dublin (9.30pm-1pm). The theme of the CPD meeting is 'Medicines Shortages'. Confirmed speakers include Dr Caitriona Fisher (Director Quality, Scientific Affairs and Communications, HPRA) and Edel Sweeney (Quality Director, Uniphar Group). 

The PIER AGM will take place after the CPD meeting. 

To register, email education@pier.ie before Thursday 21st November 2019. 

Overview of Webinar
The presentation will cover the GMP requirements and the practical implementation of a management system for quality related documentation. After an introduction referencing the relevant GMP norms and guidances, the different types of documents will be described with their function in the Quality System and their requirements. Paper and electronic based systems will be described with their peculiarities. The presentation will continue with a description of the most frequent deficiencies in documentation management, including some examples of Authorities’ observations during inspections (observations from FDA, EMA and MHRA inspections will be presented). Finally, some best practices will be presented, combining GMP compliance and efficiency in documentation management and recommended by the speaker based on his experience.
 
 
About the Speaker
Alessandro Regola is currently a free-lance consultant in Pharmaceutical Sciences with main activities in the areas of cGMP and Pharmaceutical Quality System, and in optimisation or problem solving/trouble shooting. He graduated from the University of Milan in Medicinal Chemistry and Pharmaceutical Technology and has extensive experience in the pharmaceutical industry. He spent ten years working for several different companies in R&D, first in organic synthesis of small molecules and then in pharmaceutical technology. He switched to drug product manufacturing, obtaining significant experience in GMP and Quality Systems applied to dosage forms ranging from sterile products to oral solids and semisolids. His last job in the pharma industry was as head of Quality Unit of the Garbagnate and Segrate sites of Bayer Health Care Manufacturing in Milano which included responsibility for Quality Assurance and Quality Control. He regularly collaborates with Academic and Professional Societies and holds lectures and presentations at University and Industry / Regulatory Meetings.
 
 
Learning Outcomes
By the end of this presentation, you will:
1. Understand norms and guidelines requirements for documentation management
2. Understand documentation types used in the pharma industry and their characteristics
3. Be familiar with the Authorities’ interpretation of requirements and most frequent observations during inspections
4. Be informed about best practices combining GMP compliance and efficiency in documentation management
 
 
To Join the Webinar
Please register for the event by filling out the form in the event flyer EIPG PIER GMP Documentation Management webinar_18th Nov 2019
 
Further instructions will then be sent by e-mail.
 
 

PIER is collaborating with UCC School of Pharmacy & UCC Pharmacy Society to organise an industry career information event in the Brookfield Health Science Complex on Thursday evening 14th November 2019 (7.00pm-9.00pm). Hear from a panel of experienced pharmacists working in different industry roles including Commerical, Market Access, Medical Affairs, Regulatory Affair and Quality. For further details, see the event flyer PIER UCC Career Information Evening_14th Nov 2019

To register email piercareerevents@gmail.com before Tues 12th November 2019. 

Continuing on with the PIER Career Focus webinars highlighting some of the careers that pharmacists hold in industry, Dr Donal Og O'Donovan (Regeneron Ireland) will present on 'Introduction to Pharmacovigilance, Risk Management and Medicine Safety' on Wednesday 23rd Oct 2019 @ 1.00pm. See event flyer for further information PV, Risk Management & Drug Safety Career Webinar.

Email education@pier.ie to register. 

PIER: Communications & Confidence Building Workshop (Pre-2020 Mentorship Programme)

Date: Wednesday 13th November 2019

Time: 9.30am – 4pm 

Location: Red Cow Moran Hotel, Dublin

 

Overview: 

The PIER committee is organising a one-day customised workshop for experienced patient-facing pharmacists who wish to transition into an industry role. It will also act as a forum to galvanise participation in the PIER 2020 mentorship programme due to commence in January 2020. The workshop will focus on building core competency in communications & individual confidence – leveraging participant’s transferrable skills into industry opportunities.

This will be an interactive workshop facilitated by external career consultant Margaret Dorgan to include role-play and positioning techniques.

Workshop Outputs:

● Communicate Effectively – Fundamental skills of listening, questioning & feedback.

● Identify individual skill set - Bridging a synergy within industry.

● Build Resilience, Optimism & Self Motivation.

● Highlight alignment across sectors with recruitment industry.

● Networking Skills – Rapport and Emotional Intelligence.

● SWOT analysis.

● Craft a Position Statement.

Attendance at this workshop is free for PIER members. Spaces are limited so early registration is recommended. To register, please email piermentorship@gmail.com with a brief summary of your background and professional experience.

See event flyer PIER Communications & Confidence Building Workshop_13th Nov 2019

 

Continuing on with the PIER Career Focus webinars highlighting some of the careers that pharmacists hold in industry, Maria Cawley (Sanofi Genzyme) will present on 'Medical Affairs-A Rewarding Career for Pharmacists' on Thursday 19th September 2019 at 7.30pm. 

For further information see the event flyer PIER Career Webinar on Medical Affairs_19th Sept 2019

Email education@pier.ie to register. 

PIER in collaboration with EIPG & UCC School of Pharmacy is delighted to organise the following webinar 'The Development & Regulatory Approval of Orphan Medicines' on Tues 15th Oct 2019 at 4pm. 
 
Overview of Webinar
40 years ago, rare diseases and the development of medicines to treat them were not being addressed. Investment, research and development focussed on diseases where populations were large and the likely return on investment was favourable. Today, orphan medicines are rising stars. Some of the world’s best-selling medicines are for the treatment of orphan diseases. The potential return on investment is favourable and large pharma companies have grown their own and acquired rare disease companies. There are also hundreds of start-ups, blooming across the USA and Europe attracting funding and investment. This webinar will describe how legislative changes incentivised research and development in rare diseases, the pathways and procedures to develop and approve new orphan medicines and where to find trusted information. The webinar will cover the development and regulatory approval of orphan medicines in the European Union.
 
Learning Outcomes
By the end of this presentation, you will be able to:
  1. Define what is meant by an orphan disease
  2. Define what is meant by an orphan medicine
  3. Understand the incentives available to develop new orphan medicines
  4. Appreciate the special needs for the development of orphan medicines for children
  5. Consider the importance of re-purposing older medicines for the treatment of orphan diseases
  6. Consider formulation and supply problems specific to some orphan medicines
  7. Understand the lifecycle of an orphan medicine, including applying for orphan designation, applying for a Marketing Authorisation application for an orphan medicine, and postauthorisation activities
  8. Find trusted information on orphan diseases and medicines
About the Speaker
John Watson BSc MBA MTOPRA has worked for four SME biotechnology companies and several large pharma companies. He currently works for Zogenix International Ltd as Head of Regulatory Affairs Europe. John has vast experience in the strategy, preparation, submission, negotiation of approval and maintenance of medicines regulated using the EU centralised procedure including twenty Marketing Authorisations. He has planned and managed the development and submission of eight orphan medicine applications, and many CHMP and national scientific advice procedures.
 
 
To Join the Webinar
Please register for the event by filling out the form in the attached flyer EIPG PIER Orphan Medicines Webinar_15th Oct 2019
Further instructions will then be sent by e-mail.
 

PIER members are invited to a site visit at Alexion’s biologics manufacturing site in College Park, Blanchardstown (Eircode D15 R925) on Friday 13th September 2019 from 1.00-4.00pm.

Visitors will have the opportunity to visit different areas of the site including:

  • Quality Control Centre of Excellence
  • Global Packaging and Labelling facility
  • Window tour of the newly constructed Bulk Drug Substance facility.

For further information, see Alexion site visit flyer_13th Sept 2019

Numbers are limited so places will be allocated on a first come, first served basis. Email education@pier.ie to register before Monday 9th September 2019.

Title: 'The Microbiome and Stress' – Related Psychiatric Disorders - A prescription for therapeutic  targeting of the gut/brain axis

Overview of Webinar

The gut microbiome can signal along the gut-brain axis to influence many fundamental aspects of brain function and behaviour of relevance to Psychiatry. This includes depression, anxiety and pain as well as host stress physiology. Many of the behaviours influenced by the gut microbiota rely on intact serotonergic neurotransmission and serotonin is a key neurotransmitter at both terminals of this bidirectional communication network. Moreover, many commonly used drugs in Psychiatry may exert effects on the bacteria in our gastrointestinal tract. Research efforts continue to identify the precise mechanisms underpinning these effects and possible routes of communication include the vagus nerve, the neuroendocrine system and immune factors. There is now an increasing focus on microbial regulation of tryptophan metabolism and the serotonergic system arising from a number of key observations taken from a variety of strategies used to parse the role of microbiota in brain function. Psychiatric disorders, including depression, are also now linked to compositional alterations in the gut microbiome associated with prominent symptomatic features. These translational insights will be critical as we move promising preclinical research towards mechanisms and clinical interventions such as psychobiotics to confer mental health benefits.

About the Speaker

Dr Gerard Clarke is a lecturer in the Department of Psychiatry and Neurobehavioural Science and a faculty investigator in APC Microbiome Ireland. Gerard graduated with a B.Sc (Hons) in Chemistry from NUI, Galway followed by a M.Sc in Neuropharmacology from the same institution. He subsequently received a Ph.D (Department of Psychiatry) from University College Cork (UCC). Gerard was a visiting scientist in the University of Mississippi Medical Centre in Jackson prior to working for a number of pharmaceutical companies in both Ireland and Australia, including Wyeth, Pfizer and 3M. His research interests include translational biomarkers of stress-related neuropsychiatric disorders, the impact of the gut microbiome on brain and behaviour across the life span and microbial regulation of tryptophan metabolism. His research has been recognised internationally by travel awards from the European College of Neuropsychopharmacology (ECNP) as well as a prestigious career development award from the American Neurogastroenterology and Motility Society (ANMS) and a NARSAD award from the Brain and Behaviour Research Foundation. He is a co-author of over 120 peer-reviewed papers (h-index = 49), 5 book chapters and has recently edited a book titled ‘The Gut Microbiome and Behaviour’

Learning Outcomes

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

  1. Define the impact of the gut microbiome on brain function and behaviour;
  2. Understand the possible routes of communication between the gut and the brain;
  3. Identify the options for therapeutic targeting of the gut microbiome.

To Join the Webinar

Please register for the event by filling out the form at https://docs.google.com/forms/d/e/1FAIpQLSfvBx8pq07TaXAMH0d9QYrrAXX-_R1ANqbT5h5zxqSnYysXOQ/viewform. Further instructions will then be sent by e-mail.

See flyer for the event EIPG PIER Microbiome & Stress webinar_17th June 2019

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