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Pharmaceutical Education And Research with Regulatory Links. |
Regulatory Science Symposium
21st June 2017, University College Cork, Ireland
PEARRL is a European Training Network (ETN) focused on developing innovative drug formulation strategies and regulatory tools designed to expedite the development of emerging drug molecules into new licensed medicines.
The PEARRL network will host a Symposium on Regulatory Science on Wednesday 21st June 2017 at the School of Pharmacy, UCC, CORK.
The theme for the Open Symposium is 'Regulatory Support of Innovation in the Pharmaceutical Industry'. There is an exciting list of speakers at the event including speakers from the HPRA, EMA, MHRA and BfArM. There will be four distinct sessions, with a round table discussion at then end of each session.
The PEARRL network will host a Symposium on Regulatory Science on Wednesday 21st June 2017 at the School of Pharmacy, UCC, CORK.
The theme for the Open Symposium is 'Regulatory Support of Innovation in the Pharmaceutical Industry'. There is an exciting list of speakers at the event including speakers from the HPRA, EMA, MHRA and BfArM. There will be four distinct sessions, with a round table discussion at then end of each session.
Programme (provisional)
Session 1: Regulatory Pathways adapting to Innovation Chair: Brendan Griffin
Time |
Session |
Speaker |
Notes |
9:10-9:15 |
Introduction to the PEARRL Regulatory science Symposium |
Brendan Griffin, UCC |
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9:15-9:45 |
Identifying and supporting fast track medicines i.e. PRIME, adaptive pathways |
Evangelos Kotzagiorgis, EMA |
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9:45-10:15 |
Supporting innovation through Scientific Advice |
Peter Kiely, HPRA & Sean Jones, MHRA |
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10:15-10:45 |
Orphan medicines – driving development of new (and old) drugs for rare diseases |
Dan O'Connor, MHRA |
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10:45-11:00 |
Discussion followed by coffee |
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Session 2: How the HPRA is dealing with Innovation Chair: MHRA
Time |
Session |
Speaker |
Notes |
11:20-11:45 |
Innovation benefits and risks |
Una Moore, HPRA |
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11:50-12:15 |
Supporting Innovation through Regulation and Science |
Laurence O’ Dwyer, HPRA |
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12:15-12:40 |
Supporting Medical Device Innovation |
Tom Melvin, HPRA |
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12:40-13:00 |
Discussion followed by lunch from 1-2pm |
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Session 3: Innovation and Clinical Trials Chair: Jayne Crowe, HPRA
Time |
Session |
Speaker |
Notes |
14:00-14:30 |
First in Man Studies |
Martin O'Kane, MHRA |
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14:30-15:00 |
An Irish investigator’s experience of Clinical Trials in special populations |
Geraldine Boylan, Irish Centre for Fetal & Neonatal Translational Research, UCC |
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15:00-15:15 |
Discussion followed by coffee |
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Session 4: Innovation in manufacturing Chair: Jayne Crowe, HPRA
Time |
Session |
Speaker |
Notes |
15:30-16:00 |
Quality by Design |
Jobst Limberq, BfArM |
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16:00-16:30 |
Process Analytical Technology and Continuous Manufacturing |
Nick Lee, HPRA |
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16:30-16:45 |
Discussion followed post symposium reception |
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17:00-18:00 Post Symposium reception School of Pharmacy main reception area
Invited Speakers (Provisional list)
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Dr. Evangelos Kotzagiorgis, MPharm
Scientific Administrator, Quality of Medicines, Human Medicines Evaluation Div European Medicine Agency (EMA), London Bibliography |
Dr. Peter Kiely
Clinical Assessment Manager, Health Products Regulatory Authority, (HPRA), Ireland Bibliography |
Dr. Sean Jones
Pharmaceutical Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom Bibliography |
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Prof. Geraldine Boylan
Irish Centre for Fetal & Neonatal Translational Research (UCC), Ireland |
Laurence O'Dwyer
Scientific Affairs Manager, Health Products Regulatory Authority (HPRA), Ireland Bibliography |
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Tom Melvin
Health Products Regulatory Authority (HPRA), Ireland |
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Colm Reddington
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom Bibliography |
About PEARRL
PEARRL is a European Training Network (ETN) funded under the Horizon 2020 Marie Sklodowska-Curie actions. It brings together European Pharma industry, academia and regulatory agency partners in a multisectorial team to deliver a unique research and training programme for 15 Early Stage Researchers (ESR).
The main research objectives of the PEARRL research programme are to deliver novel bio-enabling formulations and new biopharmaceutics tools to predict their in vivo performance as a means to improve efficiency and cost-competitiveness in drug development, thus facilitating earlier access of patients to “breakthrough therapies”.
PEARRL will train 15 Early Stage Researchers (ESR) who can develop such new bio-enabling formulations (“better drugs”), biorelevant and in silico methods to predict formulation performance in vivo (“streamlined development”) and serve as communication bridgers between research and regulatory science (“accelerated approval”), thus bringing Pharma and regulatory objectives to fruition.
Venue
About Cork
Cork, located on Ireland’s south coast, is the Republic of Ireland’s second largest city. The history of Cork dates back to a monastic settlement, founded by St Finbar in the sixth century however the ancestor of the modern city was founded between 915 and 922, when Viking settlers established a trading community. Today Cork is a powerhouse of economic, industrial and business development. Cork is recognised internationally as a major European centre for the life science industry with eight of the top ten pharmaceutical companies in the world located in the greater Cork area. Cork International Airport serves over 50 international destinations. Cork is a vibrant and cosmopolitan city with a population of over 123,000 people yet it still manages to retain the pleasant charm and friendliness of a country town. The surrounding country is also lush and beautiful. Cork County boasts a magnificent coastline scooped and fretted by the Atlantic into great bays, secret coves, rocky headlands and long golden sands.
Cork is the Food Capital of Ireland, home to the birthplace of modern Irish Cuisine at Ballymaloe House, the famed English Market and home to artisan food producers. Don’t just take our word for it - as Lonely Planet themselves said ‘Everything good about Ireland can be found in County Cork’.
Cork, located on Ireland’s south coast, is the Republic of Ireland’s second largest city. The history of Cork dates back to a monastic settlement, founded by St Finbar in the sixth century however the ancestor of the modern city was founded between 915 and 922, when Viking settlers established a trading community. Today Cork is a powerhouse of economic, industrial and business development. Cork is recognised internationally as a major European centre for the life science industry with eight of the top ten pharmaceutical companies in the world located in the greater Cork area. Cork International Airport serves over 50 international destinations. Cork is a vibrant and cosmopolitan city with a population of over 123,000 people yet it still manages to retain the pleasant charm and friendliness of a country town. The surrounding country is also lush and beautiful. Cork County boasts a magnificent coastline scooped and fretted by the Atlantic into great bays, secret coves, rocky headlands and long golden sands.
Cork is the Food Capital of Ireland, home to the birthplace of modern Irish Cuisine at Ballymaloe House, the famed English Market and home to artisan food producers. Don’t just take our word for it - as Lonely Planet themselves said ‘Everything good about Ireland can be found in County Cork’.
