Are you joining us at the Q1 Scientific Stability Studies 2024 Conference? This event is a must attend for analytical and quality professionals working for pharmaceutical and medical device companies. As the Q1 Scientific Stability Studies Conference 2024 approaches, you may have common questions about making the most of this valuable event.
Here are some common questions attendees have about the conference, along with what you can expect to learn at the event.
When is the conference?
The third annual stability studies conference is taking place on Thursday 17th of October 2024 from 08:30 am to 15:30 pm at the Killashee Hotel, Naas.
Registration and Logistics
How do I register for the conference? Registration is simple! Visit the conference registration page and follow the steps to secure your spot.
What is the deadline for registration? Make sure to register before the event date, October 17, 2024. Early registration is recommended to take advantage of any discounts and to ensure your place.
Are there any discounts available for early registration or group bookings? Yes, early bird discounts are available if you register before September 30th, 2024. Additionally, group discounts are offered for companies purchasing three or more tickets.
What is the exact location of the conference venue? The conference will be held at the Killashee Hotel, Naas, Co. Kildare, Ireland.
Is there parking available at the Killashee Hotel? Yes, the Killashee Hotel offers ample parking for all attendees.
Conference Agenda
What time does the conference start and end? The conference begins at 08:30 with registration and a light breakfast, and it concludes at 15:30.
Can I get a detailed agenda of the sessions and speakers? A detailed agenda will be provided closer to the event date. Keep an eye on the conference website for updates.
Will there be breaks for networking and refreshments? Yes, there are scheduled breaks throughout the day for networking and refreshments. You can look forward to building connections with peers and experts in the field, sharing experiences, and potentially collaborating on future projects.
Speakers and Sessions at Stability Studies 2024 Conference
Who are the speakers? The conference features an incredible lineup of distinguished speakers, including:
- Nuala Calnan, PhD, CEO of BioPharm Excel, discussing Stability testing from bench to bedside – understanding the why. Nuala is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and includes research for FDA(USA) and HPRA(Ireland) on risk surveillance, patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end proactive risk management, implementing knowledge excellence strategies, behavior-based quality excellence and enhancing performance management through people. She is the founder of the Quality Risk Management Institute and CEO at BioPharm Excel. Nuala co-leads the ISPE Cultural Excellence Team, acted as Technical Author on the ISPE Advancing Pharmaceutical Quality (APQ) Guide series. At TU Dublin, Ireland, Nuala leads a number of patient focused regulatory science research projects at Masters and PhD level.
- Stan O’Neill, Managing Director of The Compliance Group, sharing insights on GMP considerations for Stability Testing. After qualifying as a Pharmacist, Stan spent over five years working in the pharmaceutical industry in Regulatory Affairs, Marketing and Quality Assurance (as a QP). He then joined the Irish Medicines Board (IMB, now the HPRA). As a Senior Inspector, he performed GMP inspections throughout the world and represented Ireland at European level for the negotiation of standards of inspection for medicinal products. During his time with the IMB Stan trained Inspectors for Sterile Medicinal Products, non-Sterile Medicinal Products and Good Distribution Practice and Pharmacovigilance. Since founding The Compliance Group in 2009 Stan has consulted for many Pharmaceutical Companies, Hospitals, Governments, the World Health Organisation, and NGOs. Stan holds the positions of Adjunct Assistant Professor, School of Pharmacy and Pharmaceutical Sciences in Trinity College Dublin and Honorary Associate Professor, RCSI, University of Medicine and Health Sciences.
- Catherine McHugh, Owner and Director of Imbolc Pharma Consulting, offering practical approaches to stability data challenges in regulatory submissions. A Pharmacist by training, Catherine started her career in the pharmaceutical industry in product development with 3M Healthcare and subsequently spent >8 years as a Pharmaceutical Assessor with the Health Products Regulatory Authority (HPRA) in Ireland assessing all types of applications for small molecule drug products (e.g. Clinical trials, CHMP scientific advice, National, MRP, DCP, and Centralised marketing authorisation applications, variations, renewals). During this time, she was a designated national expert at the EMA and a member of the Joint CHMP / CVMP Quality Working Party. Catherine spent the last 10 years as a Regulatory / CMC consultant with global consulting organisations providing leadership to the consulting team and technical support to international clients and set up Imbolc Pharma Consulting in May 2024 to provide personalised services to the Pharma and Biotech industry in Europe.
- Dr. Mark Powell, Director of MP Scientific, is addressing out-of-trend and variable stability data. Dr. Mark Powell is a Fellow of the Royal Society of Chemistry with over 30 years of experience as a senior analytical chemist. He is an expert in stability studies, sampling, chromatography, and pharmaceutical dissolution testing. Mark has held senior roles in both academia and industry, contributing significantly to analytical development and quality assurance.
- Kate Coleman, Vice President of Regulatory Affairs, Quality and Compliance at Arriello. Kate Coleman brings over 20 years in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a Qualified Person, Principal Consultant, Lead Auditor and an SME in several areas including Quality Control and Stability. Kate’s expertise in regulatory affairs and compliance make her a valuable asset to the conference.
- Stephen Delaney, Managing Director at Q1 Scientific, is providing an overview of outsourcing stability storage. Stephen Delaney has been leading Q1 Scientific since 2018 and became Managing Director in 2022. Under his leadership, Q1 Scientific has expanded its facilities and won several industry awards. Stephen’s background in materials technology and business management equips him with the knowledge to oversee critical pharmaceutical storage and logistics.
What topics will be covered in the sessions? Topics include regulatory requirements, stability testing and storage – from both an analytical and quality perspective. You can expect to gain practical guidance on optimising your stability study processes, designing studies, working with regulators and managing data. Listen to real-world examples and case studies for valuable insights allowing you to learn from the experiences of others and understand how to apply these lessons to your own work.
Will there be opportunities to ask questions during the sessions? Yes, there will be Q&A sessions where attendees can engage with the speakers and ask questions.
Can I get access to the presentation materials after the conference? Presentation materials are available to attendees after the conference. Details on how to access these will be provided during the event.
Accommodation and Travel
Are there any hotels nearby for attendees who are staying? The Killashee Hotel is the primary accommodation option, but there are other nearby hotels.
Is there a special rate for conference attendees at the Killashee Hotel? Yes, there is a special rate for conference attendees. Be sure to mention the conference when booking your room.
What are the best transportation options to get to the venue? The Killashee Hotel is accessible by car, and there are public transportation options available. Detailed directions and transportation information are available on the hotel’s website.
General Information about the Stability Studies 2024 Conference
What is the dress code for the conference? The dress code is business casual. Comfortable attire is recommended for a full day of sessions and networking.
Will there be Wi-Fi available at the venue? Yes, complimentary Wi-Fi will be available for all attendees.
How can I contact Q1 Scientific if I have more questions? For any additional questions, you can contact us through the contact form on the conference website.
Register for Stability Studies 2024
We hope this answers your questions and helps you prepare for a productive and enjoyable experience at the Q1 Scientific Stability Studies 2024 Conference!