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Created: 27 August 2019

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

Created: 13 August 2019

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.

Created: 10 June 2019

HiTech Health focuses on enabling healthcare companies to launch and support products. The company was established in 2013 in Dublin, Ireland, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports healthcare companies from the development to the launch and supply of products.

HiTech Health are now recruiting for the position of Qualified Person. This is an exciting role for a dynamic individual to join a growing organisation, to work with a number of clients and contribute to a variety of projects.

The role involves supporting Quality Assurance activities for HiTech Health as a service provider to clients. The candidate will play a key role in the development of the company. The ideal candidate will be responsible for ensuring quality compliance with U.S. and E.U. requirements from early development right through to commercial manufacturing and supply to patients.

Please see the following link for more information;     http://hitech-health.com/qualified-person/

Created: 08 June 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. 

Created: 05 June 2019

The TCP Group is a healthcare service provider, specialising in ‘direct to patient services’ which include the dispensing and distribution of pharmaceutical products, homecare nursing services and sharps waste management, facilitating a unique turnkey solution for the delivery of hospital care in the patient’s home.

TCP Homecare is currently recruiting for a Quality Manager position based in their Head Office in Dublin. The role of the Quality Manager/Responsible Person will be to develop and maintain a QMS whilst meeting the requirements of regulatory and quality standards for GDP/PSI/Nursing services. For further information, see the job description TCP Quality Manager position

Posted 5th June 2019

Created: 04 June 2019

Join the PIER committee for the annual BBQ in D Two, 60 Harcourt St, Dublin 2 on Thursday 27th June 2019 from 6.30pm. 

Created: 20 May 2019

Dr Gerard (Ger) Clarke from the School of Psychiatry & APC University College Cork will present on 'The Microbiome and Stress' – Related Psychiatric Disorders - A prescription for therapeutic  targeting of the gut/brain axis. 

Further information will be available re registration in the near future. 

Created: 01 May 2019

TCD are currently taking applications for the Postgrad Diploma/MSc in Pharmaceutical Medicine. This course has been developed to provide medical and science graduates with specialist knowledge and skills in the area of clinical pharmacology and pharmaceutical medicine. Many pharmacists who have transitioned to industry in recent years have undertaken this course. Components of the course include principles of:

• Pharmacology and biostatistics
• New drug development and the regulatory environment
• Pharmacoeconomics and rational use of drugs
• Pharmacovigilance and drug information

The course involves completion of taught modules and the additional undertaking of a research project. The modules consist of formal teaching and personal assignments and are run over five terms on a part-time basis (approximately two modules per term). Some of the modules are undertaken by way of distance learning. In addition, the students are assigned a research project (including field work), to be submitted as a dissertation for the MSc degree only.

Closing date for applications is 31st July 2019. 

See course flyer TCD Pharmaceutical Medicine flyer.