2023


Q1 Conference

SCHEDULE

08:30
08:30
Registration and light breakfast
The Orangery, Killashee Hotel
The Orangery, Killashee Hotel
09:00 - 09:05
09:00 - 09:05
Welcome to the Q1 Scientific Stability Studies 2023 conference
Stephen Delaney, Managing Director at Q1 Scientific - a Cambrex company
Thompson Suite
Thompson Suite
09:05 - 09:45
09:05 - 09:45
How stability testing impacts the development of drug products
Darryl Souness - Head of Analytical at Cambrex
Thompson Suite

How 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:

  • The importance of early method development with regard to stability testing
  • The role of forced degradation and its impact on method development
  • Initial elucidation of unknown impurities during early-stage development to assist in method development

Followed by a Q&A session with Darryl Souness.

Thompson Suite
09:45 - 10:00
09:45 - 10:00
Q1 Scientific Belgium: A new facility for stability storage services in Europe
Cecile Jacoby - General Manager, Q1 Scientific Belgium
Thompson Suite

Q1 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:

  • Rationale and vision behind Q1 Scientific’s expansion in Europe
  • Challenges and opportunities of establishing a new facility in Belgium
  • Design and operation of the state-of-the-art temperature-controlled and monitored storage facility
  • Quality and regulatory aspects of providing stability storage services in Europe

Followed by a short Q&A session with Cecile Jacoby.

Thompson Suite
10:00 - 11:00
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 data
Theresa Jeary - Principal Technical Specialist, Medicinal & Biologics at BSI
Thompson Suite

In 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
11:00 - 11:30
Morning break
Ainsworth Suite
Ainsworth Suite
11:30 - 12:30
11:30 - 12:30
A practical approach to stability program compliance
Kate Coleman, Principal Consultant
Thompson Suite

With 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
12:30 - 13:30
Lunch and networking
Tea, coffee and sandwiches
Ainsworth Suite
Ainsworth Suite
13:30 - 14:30
13:30 - 14:30
Stability Studies in support of pharmaceutical development
Dr. Mark Powell, Director at MP Scientific
Thompson Suite

Pharmaceutical 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:

  • Introduction to Quality by Design
  • ICH Q8 (Pharmaceutical Development) – stability requirements
  • API and drug product stress studies
  • Excipient compatibility and prototype stability studies
  • In-use/reconstitution stability studies

Followed by a Q&A session with Dr. Mark Powell

Thompson Suite
14:30 - 15:15
14:30 - 15:15
Revolutionising Pharma: How AI will Transform Process Development
Dr. Niamh Mac Fhionnlaoich, Research Fellow at APC
Thompson Suite

AI 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:

  • Reaction design
  • Crystallisation
  • Particle property prediction

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
15:15 - 15:30
Closing Q&A
Stephen Delaney, Managing Director at Q1 Scientific - a Cambrex company
Thompson Suite

Closing Q&A with our panel of guest speakers and Christopher Hartnett, Business Development Manager at EMBALL’ISO.

Thompson Suite

Conference 2023

SPEAKERS

Dr. Mark Powell

Dr. Mark Powell

Director at MP Scientific
Theresa Jeary

Theresa Jeary

Principal Technical Specialist, Medicinal & Biologics at BSI
Kate Coleman

Kate Coleman

Vice President Regulatory Affairs, Quality and Compliance (Principal Consultant) at Arriello
Dr. Niamh Mac Fhionnlaoich

Dr. Niamh Mac Fhionnlaoich

Research Fellow at APC
Darryl Souness

Darryl Souness

Head of Analytical at Cambrex
Christopher Hartnett

Christopher Hartnett

Business Development Manager at EMBALL'ISO
Cecile Jacoby General Manager at Q1 Scientific Belgium

Cecile Jacoby

General Manager at Q1 Scientific Belgium
Stephen Delaney

Stephen Delaney

Managing Director at Q1 Scientific – a Cambrex company