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PDA Ireland Chapter

Ann McGee

President:Anne McGee

PharmaLex Ireland Limited

Overview

Thank you for connecting to the PDA Irish Chapter page.

As a registered non-profit affiliate of PDA International; our aim is to serve as a networking forum for manufacturers, young professionals, academia and service providers engaged in the pharmaceutical/ biopharmaceutical industry in Ireland.

The activities of our chapter can be summarised as follows:

  • Provide events and processes to facilitate sharing of best practices, technologies and regulations to meet the tactical and strategic needs of you; our members.
  • Facilitate collaboration with regulators and other representative bodies to achieve alignment and cohesiveness across the industry.
  • Provide a great networking opportunity for you; our members to connect with like-minded professionals, subject matter experts and regulators.

Our success depends on the willingness of our volunteers to share experiences, plan & organise events, engage in PDA interest groups or contribute to future technical reports.

Remember we all face similar opportunities and challenges; our chapter network can strengthen our ability to face these with confidence.

Le chéile tá muid níos láidre (Together we are stronger),

Join today!!!
Declan Quinlan, President Irish Chapter

 

Thank you to our 2019 Chapter Sponsors

Diamond Sponsors

  • Bioquell
  • Cherwell
  • Elis
  • PMT
  • Source Bioscience
  • Thermal Compliance

Bronze Sponsors

  • Charles River
  • Fraser Technologies
  • Pharmalex
  • SteriTech Limited
  • Veltek
 

Upcoming Chapter Events

Coming soon.

PDA Signature Events

 

Officers

President

Declan Quinlan

Declan Quinlan
Operations Director
MSD Ireland (Carlow)
[email protected]

President-Elect
Ann McGe

Ann McGee
Managing Director
PharmaLex Ireland
[email protected]

Secretary
Aidan Harrington

Aidan Harrington
Senior Consultant
DPS Global
[email protected]

Treasurer
Paul Hawkins

Paul Hawkins
Quality Director
Theratechnologies
[email protected]

Sponsorship and Events Manager
Elizabeth Hunt

Elizabeth Hunt
Marketing Specialist
PharmaLex Ireland
[email protected]

 

Chapter News

Hope you are all refreshed after the Summer and ready for the usual sprint to year-end!!.

Since our last Newsletter, we have had many very successful activities engaging both our young professionals and professionals.

This was the third year of our student bursary, and we had the most significant number of applications to date. We sponsor two students to attend the annual PDA meeting each year. Our two winners in 2019 were Rebecca Kelly and David O'Loughlin – hopefully, you have seen the excellent articles they wrote documenting their experiences at the meeting.

Additionally, our research workstream has been working with UCC school of Pharmacy to sponsor a research thesis assessing the impact of Annex 1 changes.

Our first event of the year was the Annex 1 event on 03rd May in the Crown Plaza Blanchardstown, Dublin. The interest in this event was tremendous, and it was sold out weeks in advance – a first for our chapter. Not surprising given the line-up of speakers and diversity of perspective which included regulators, ex-regulators, industry experts, and vendors resulting in excellent debate/ discussion and exchange of ideas.

The second event which took place at the Radisson Blu Hotel in Cork on 20th June was " A practical approach to Quality Risk Management'. We had several speakers present on the challenges and successes they faced in implementing Quality Risk Management at their sites. I found the honesty and openness of the presenters in sharing what worked and as important – what didn't work. This is at the core of what our chapter needs to be – a forum where we can openly share and discuss our successes and challenges and learn together.

Our keynote speaker for this event was Kevin O'Donnell who gave a very thought-provoking presentation and challenged us as an industry to ask the question; are the risk assessments we complete in our companies really helping us to understand and mitigate our risks and if they are; why are the number of recalls, customer complaints and quality events on the increase?

Our communication & marketing workstream, driven by Elizabeth continues to exceed our expectations. This has led to continued engagement by sponsors allowing us to invest further and improve our events. Additionally, we continue to see significant growth in our LinkedIn and Twitter presence.

In the spirit of giving; we donated to the "Barretstown" charity. The reason we selected this charity is we feel their mission to rebuild the lives of children affected by cancer and severe illness is very aligned with what many of us do every day in making medicines to improve and sustain the lives of our patients.

Looking forward to the next three months; our Young Professionals committee have organised a great event at MSD Carlow on 18th October, which is titled "Meeting the Digital Challenge." This event discusses the benefits of augmented reality, and digitisation can bring to our industry. The event is limited to forty attendees, so if you are a YP and interested; book today!!.

Our final event of the year is Visual Inspection on 22nd November in Carton House, Kildare - this promises to be a fantastic event addressing current requirements (including recent HPRA observations), practical implementation and future emerging technologies in the visual inspection space. This event also incorporates our AGM.

None of the above would be possible without our dedicated committee/ event organising teams who continue to raise the bar ever higher to ensure we meet the expectations of our members, attendees, and sponsors.

Finally, as always a heartfelt thanks to you; the members of our Irish chapter who continue to contribute to our success and provide us with feedback to ensure we continue to strive to meet and exceed your expectations,

Le chéile tá muid níos láidre (Together we are stronger),

Declan Quinlan,
President Irish Chapter

Thank you to our 2019 Chapter Sponsors

David O’Loughlin Shares PDA Europe Annual Experience

David O’Loughlin

Earlier this year, I was honoured to be one of two students awarded a bursary to attend the 4th PDA Europe Annual meeting in the beautiful city of Amsterdam. The theme of this year's conference was "Global Healthcare of the Present and the Future." Having just finished my third year on the BSc in Pharmaceutical and Biomedical Chemistry at Maynooth University, I was keen to see how technology is advancing in an increasingly digital and paperless age.

On the first day, I met the members of the Irish PDA chapter and had an opportunity to see the many stalls from exhibitors.

One of the sessions I especially enjoyed was Derek Duncan's talk on "Ensuring Container Closure Integrity of Gene Therapy Products Needing Deep Cold Storage" Dr. Duncan was from LIGHTHOUSE Instruments who design and develop non-destructive analysis equipment for determining the gas composition of the headspace. Their instruments can determine if CO2 has leached into gene therapy vials during storage on dry ice. CO2 ingress shows that during storage, the vial has been compromised, which could lead to contamination of the product.

The highlight of the conference for me was Jose Castillo's talk on "Low-footprint, Intensified, Single Use Platform for the Production of Viral Vaccines. The team in Univercells have developed 'NevoLine,' a viral vaccine production technology that cuts the footprint of a facility from 5000-10,000m2 to 1500m2 and they estimate the cost per dose will fall from US$1.2-1.5 to US$0.3. In a world facing into a shortage of vaccines with a supply gap for IPV of around 50 million doses/year, any system which can reduce the footprint required to develop these vaccines is extremely valuable.

Other sessions were highlighting the potential for new technology, including one on the implementation of BlockChain technology into the pharmaceutical industry. It was fantastic to get exposure to regulation in the industry. We had been told about the importance of regulation but had no first-hand experience of it. So I found the keynote speeches from the FDA, EMA, MHRA and WHO especially interesting.

I want to thank the PDA Ireland chapter for this wonderful opportunity, and I hope to stay involved with them in the future.

 

Rebecca Kelly Shares PDA Europe Annual Experience

Rebecca Kelly

I was honoured to be present at the 2019 PDA Europe meeting which took place on the 25th and 26th of June in Amsterdam. Below is a summary of my experience at the event. The first day of the conference began with a regulatory update consisting of information on the most recent changes in the pharmaceutical industry especially in relation to developments regarding the EMA, the FDA, the WHO, and PIC/S. For the remainder of day one and the majority of day two, the event was split into three parallel tracks with different topics at the centre of each track. The options had a wide variety and included discussions on Virtual Reality, Manufacturing Technologies, Robotics in Pharma, Implementing Technologies, Blockchain Technology, Decontamination, Sterilization Technologies, Artificial Intelligence in Pharma, Young Professionals in PDA and Personalised and Precision Medicine. As a biotechnology student, I was immediately drawn to Robotics in Pharma. I also attended the Virtual Reality and Artificial Intelligence presentations as I believe this will be the future of biotech and Pharma industries, and I am keen to gain additional knowledge on these topics. Throughout the Virtual reality presentations, the speakers conveyed how industries need to update training methods to keep up with evolving technologies. I learned that this is already being applied in the form of E-learning, but more recently, a concept called 'Deep Training' has come into use with the help of virtual reality. This type of training could be used to train manufacturing associates in a controlled manner as there would be no risk of losing product due to simple errors. The trainees would wear virtual reality goggles and carry out tasks in an area that is set up similar to a clean room. The equipment would also monitor the speed at which the user operates at; this has the potential to be very useful as it would make the user more informed and conscious about how many particles they are creating when they are moving in the cleanroom. This option also makes it possible to simulate situations that would rarely happen in the real cleanroom leading to operators being more prepared and confident in challenging situations. I enjoyed this section of the event as it shows how training will become more exciting and encourage more involvement. The speaker displayed how effective this technique is by giving us the following statistics related to different methods of training:

Training Method Percentage of Information Remembered
Reading 10
Hearing 20
Stimulating the activity 90

Next, I attended the Robotics in Pharma talk. During this presentation, we were shown a real example of a robot that could be used in many industries in the future. It could recognise obstacles in its path and re-divert in a safe way to avoid them. The speakers talked about how robotics could eventually take over specific important roles that humans currently play in the industry. As humans create up to 80 percent of contamination in clean rooms, this could be revolutionary. As well as carrying out tasks effectively and efficiently, the robots would free up time for workers to carry out other activities. The final presentations I attended were those on Artificial Intelligence in Pharma. An interesting point that was made in this section was that 'Artificial Intelligence is not always correct, but it is less incorrect than humans.' I found it hard to believe that computer systems could perform tasks that previously required human input, but I now know this is the direction many businesses will be moving towards as there are many benefits to this type of technology. An example of where this could be used in industry is in the visual inspection process. This is a time-consuming task which requires complete concentration from the inspector, so I can see the benefits of this being carried out by a computer system. Apart from the tracks, there were also exhibitions at each break where the newest technologies, methods, and equipment were displayed and explained in great detail.

The PDA conference has opened my eyes to all the new possibilities which are being developed all over the world at this moment. No doubt, in a few years, the technologies mentioned above will be taking over operations in industry and making workplaces more efficient and productive. It was a privilege to listen to each of the speakers as they shared an abundance of valuable knowledge surrounding the most recent introductions and changes to the world of medicine, science, and healthcare. I am so grateful to PDA Ireland for providing me with this fantastic opportunity, and I would like to say a special thank you to all of the Irish delegates who made me feel so welcome to the event and also those who helped to organise the trip. It was so enjoyable, and I loved every second of the beautiful Amsterdam!

 

PDA Ireland sponsors the Salters' Festival of Chemistry – hosted by Trinity College, May 18, 2019

Salters Festival of Chemistry

The Salters Institute hosted The Salters' festival to promote the appreciation of chemistry and related sciences among adolescent students. The initiative also showcases careers in the chemical and allied industries and teaching field.

On May 18th, 2019 students from 20 schools from the province of Leinster enjoyed an exciting day of scientific exploration at the Salters' Festival of Chemistry, at the Salters Institute, School of Chemistry.

Teams of four 11-13 year-olds represented their school in three chemistry focused experiments and challenges.

Our 2019 Salters' Festival winners were:

  • Loreto Secondary School, Balbriggan, Dublin
  • Holy Child Secondary School, Killiney, Dublin
  • St. Leo’s College, Dublin Road, Carlow
 

PDA Ireland made a charity donation to Barretstown - the official charity partner for 2019

PDA Ireland Sponsor Barrerstown
 

Biocidal Products Regulation – ‘cleaning’ up the marketplace

Author: John Chewins, BSc, MBS Director, Scientific and Regulatory Affairs, Bioquell UK Ltd.

This article is your guide that provides important insights into the new regulations covering bio-decontamination claims and processes in Europe.

 

PDA Ireland announce Bursary Winners

In partnership with PDA Europe, we have continued our commitment to provide educational development opportunities for students by producing our 3rd Bursary.

This year, we accepted applications to third level students (undergraduate and postgraduate). The bursary included a free ticket to the PDA EU Annual Meeting on 25 - 26 June 2019 I in Amsterdam, The Netherlands and €800.00 towards travel expenses and accommodations..

We are proud to announce the names of our 2019 Bursary recipients: Rebecca Kelly and David O'Loughlin.

Rebecca Kelly
Rebecca Kelly

Rebecca Kelly is twenty years of age from a town called Glenamaddy in Galway, Ireland. She is currently undergoing her third year of study in Biotechnology at the National University of Ireland, Galway. At this time, Rebecca is interning at Alexion Athlone.

Rebecca learned about this opportunity on the PDA Ireland Chapter's LinkedIn page.

She is interested in the industry placement session and desires to learn more about this topic during the PDA Europe (PDA EU) Annual Conference.

David O'Loughlin 
David O'Loughlin

David O'Loughlin is currently completing his third year BSc in Pharmaceutical and Biomedical Chemistry at Maynooth University. In July, he will begin the Human Toxicology student placement programme at The State Laboratory in Kildare, Ireland. David's interests include toxicity, glycobiology, and personalised medicines.

David learned about the bursary from his University's Placement Office, who posted the flyer on the student forum. "I applied because I wanted to take the opportunity to get a feel for the developing world of Pharmaceuticals and to see how some of our in-class material refers to the real world."

He is interested in several sessions at the upcoming (PDA EU) Annual conference as they may assist him in exploring future Ph.D. opportunities.

 
 

Presentations

Key Takeaways from the Annex 1 Conference in Dublin on May 3rd, 2019

 
 
 

Photos & Video

Visual Inspection, November 22, 2019
Meeting the Digital Challenge in Pharma, October 18, 2019
Practical Implementation of QRM, June 20, 2019
Annex 1, May 3, 2019
 

Sponsorship

Exhibit at PDA Ireland Events

Maximize your company's exposure to key decision-makers in the pharmaceutical and Bio-pharmaceutical industries as an exhibitor and/or sponsor at PDA Ireland events.

 Meet potential buyers and take advantage of the opportunity to:

  • Gain access to industry leaders to establish and develop important relationships
  • Get exposure in front of your target audience
  • Showcase new products and services
  • Generate visibility and valuable leads
  • Convert leads into new business
  • Create brand awareness

Diamond Sponsor

(Maximum 3 sponsors)
3,000

Per Year

  • A full exhibitors table at all PDA Events (approx 3-4 per year)
  • Company name & logo & weblink on PDA Ireland website
  • Company name & logo on promotional material for PDA events
  • Company name & logo in PDA quarterly newsletter plus 50 word statement
  • 4 x Complimentary event registrations
  • Special thank you by event MC
  • Logo appearance on hold screens during coffee and lunch breaks
  • 6 Social media promotions on PDA social media platforms
Purchase

Gold Sponsor

(Maximum 5 sponsors)
1,500

Per Year

  • Exhibitor table at 1 PDA Event
  • Company logo and name & weblink  on PDA Ireland website (1 month)
  • Company name & logo on PDA promotional material
  • Company name & logo in PDA quarterly newsletter plus 50 word statement
  • 4 Social media promotions
  • 2 x complimentary event registrations
  • Special thank you by event MC
Purchase

Bronze Sponsor

 
500

Per Year

  • Exhibitors table at 1 PDA Event
  • Company name & logo on PDA promotional material
  • 2 Social media promotions
  • 2 x complimentary event registrations
  • Special thank you by event MC
Purchase

 

Ireland Member Spotlight

Shane Costigan

Shane Costigan

Product and Logistics Manager, Reagent Genie
Member since 2018
Featured Volunteer, September
 
 

President's Message

Untitled Document

Hope you are all refreshed after the Summer and ready for the usual sprint to year end!!.

Since our last Newsletter we have had a number of very successful activities engaging both our young professionals and professionals.

This was the third year of our student bursary and we had the largest number of applications to date. We have sponsored two students to attend the PDA Annual meeting each year. Our two winners in 2019 were Rebecca Kelly and David O’Loughlin – hopefully you have seen the excellent articles they wrote documenting their experiences at the meeting.

Additionally,  our research work-stream has been working with UCC school of Pharmacy to sponsor a research thesis assessing the impact of Annex 1 changes.

Our first event of the year was the Annex 1 event on 03rd May in the Crown Plaza Blanchardstown, Dublin. The interest in this event was tremendous and it was sold out weeks in advance – a first for our chapter!! Not surprising given the line-up of speakers and diversity of perspective which included regulators, ex-regulators, industry experts and vendors resulting in excellent debate/ discussion and exchange of ideas.

The second event which took place at the Radisson Blu hotel in Cork on 20th June was “ A practical approach to Quality Risk Management’. We had a number of speakers present on the challenges and successes they faced in implementing Quality Risk Management at their sites. What was really striking for me at this event was the honesty and openness of the presenters in sharing what worked and as important – what didn’t work. This is at the core of what our chapter needs to be – a forum where we can openly share and discuss our successes and challenges and learn together.
Our keynote speaker for this event was Kevin O’Donnell who gave a very thought provoking presentation and challenged us as an industry to ask the question; "Are the risk assessments we complete in our companies really helping us to understand and mitigate our risks and if they are; why are the number of recalls, customer complaints and quality events on the increase?"

Our communication & marketing work-stream driven by Elizabeth Hunt continues to exceed our expectations. This has led to continued engagement by sponsors allowing us to further invest and improve our events.  Additionally, we continue to see significant growth in our LinkedIn and Twitter presence.

In the spirit of giving; we made a donation to the “Barretstown” charity. The reason we selected this charity is we feel their mission to rebuild the lives of children affected by cancer and serious illness is very aligned with what many of us do every day in making medicines to improve and sustain the lives of our patients.


Looking forward to the next three months; our Young Professionals committee have organised a great event at MSD Carlow on 18th October which is titled “Meeting the Digital Challenge”. This event discusses the possible benefits of augmented reality and digitization can bring to our industry. The event is limited to forty attendees so if you are a YP and interested; book today!

Our final event of the year is Visual Inspection on 22nd November in Carton House,  Kildare  - this promises to be a fantastic event addressing current requirements (including recent HPRA observations), practical implementation and future emerging technologies in the visual inspection space. This event also incorporates our AGM.

None of the above would be possible without our dedicated committee and event organization teams who continue to raise the bar ever higher to ensure we meet the expectations of our members, attendees and sponsors.

Finally, as always, a very sincere thanks to you; the members of our PDA Ireland Chapter who continue to contribute to our success and provide us with feedback to ensure we continue to strive to meet and exceed your expectations.

Le chéile tá muid níos láidre (Together we are stronger),
Declan Quinlan
President, PDA Ireland Chapter
Thank you to our 2019 PDA Ireland - Chapter Sponsors