2023
Q1 Conference
SCHEDULE
08:30 |
Registration and light breakfast |
The Orangery, Killashee Hotel |
09:00 - 09:05 |
Welcome to the Q1 Scientific Stability Studies 2023 conferenceStephen Delaney, Managing Director at Q1 Scientific - a Cambrex company |
Thompson Suite |
09:05 - 09:45 |
How stability testing impacts the development of drug productsDarryl Souness - Head of Analytical at CambrexHow can you ensure the quality and safety of drugs from start to finish? Analytical testing is essential for ensuring the quality and safety of drugs throughout their development and production stages. It helps to confirm the chemical properties of the drugs and to detect any potential issues that could hinder their progress. Therefore, having reliable, precise and high-quality analytical support for your testing needs is vital. During this presentation, Darryl will cover:
Followed by a Q&A session with Darryl Souness. |
Thompson Suite |
09:45 - 10:00 |
Q1 Scientific Belgium: A new facility for stability storage services in EuropeCecile Jacoby - General Manager, Q1 Scientific BelgiumQ1 Scientific is a leading provider of environmentally controlled stability storage services to the pharmaceutical, medical device and life sciences industries. In 2023, Q1 Scientific opened a new 20,000 square feet facility in Belgium, expanding its offering across Europe and providing faster and more flexible solutions to customers. In this presentation, Cecile Jacoby, the General Manager of Q1 Scientific Belgium, will share her experience and insights on setting up a new facility for stability storage services in Europe. Cecile will cover the:
Followed by a short Q&A session with Cecile Jacoby. |
Thompson Suite |
10:00 - 11:00 |
Product Development and Stability Considerations for Combination products in the EU – A NB Perspective on the key areas to be considered and common gaps in dataTheresa Jeary - Principal Technical Specialist, Medicinal & Biologics at BSIIn this session, Theresa shall cover the complexity of Combination Product legislation in the EU. Provide a summary of the requirements for each type of combination and look at key development considerations for both MDR Article 117 Products and MDR Rule 14 Devices. Followed by a Q&A session with Theresa Jeary. |
Thompson Suite |
11:00 - 11:30 |
Morning break |
Ainsworth Suite |
11:30 - 12:30 |
A practical approach to stability program complianceKate Coleman, Principal ConsultantWith over 20 years of experience in the pharmaceutical industry, Kate is a practising Qualified Person, Principal Consultant, Lead Auditor and an SME in several areas including Quality Control and Stability. In this presentation, Kate will cover the regulations and requirements, common issues with stability programs, the QP perspective and how to navigate the management of different types of stability programs. Followed by a Q&A session with Kate Coleman. |
Thompson Suite |
12:30 - 13:30 |
Lunch and networkingTea, coffee and sandwiches |
Ainsworth Suite |
13:30 - 14:30 |
Stability Studies in support of pharmaceutical developmentDr. Mark Powell, Director at MP ScientificPharmaceutical manufacturers are now expected to adopt a Quality by Design (QbD) approach when developing their drug products. The critical elements to successful QbD are product understanding and risk management, which are achieved by conducting appropriate experiments during development. This presentation will briefly outline the QbD model and then consider key stability studies during pharmaceutical development. During this presentation, Dr. Mark Powell will discuss:
Followed by a Q&A session with Dr. Mark Powell |
Thompson Suite |
14:30 - 15:15 |
Revolutionising Pharma: How AI will Transform Process DevelopmentDr. Niamh Mac Fhionnlaoich, Research Fellow at APCAI in our everyday lives has already become commonplace, from the facial recognition that unlocks our phones to digital assistants like Siri and Alexa. The pharmaceutical industry has already benefitted from AI in drug discovery and clinical trials. Still, as cutting-edge investigations delve into pivotal domains like reaction kinetics and crystallization design, the potential to revolutionize pharmaceutical process design becomes increasingly evident. This talk will review some of the current research being done in:
And how these developments will improve efficiency while reducing waste and cost, ultimately accelerating the delivery of a high-quality product to the patient. Followed by a Q&A session with Dr. Niamh Mac Fhionnlaoich |
Thompson Suite |
15:15 - 15:30 |
Closing Q&AStephen Delaney, Managing Director at Q1 Scientific - a Cambrex companyClosing Q&A with our panel of guest speakers and Christopher Hartnett, Business Development Manager at EMBALL’ISO. |
Thompson Suite |