Announcing the Autumn 2023
SeerPharma UK Symposium

 

In person: Birmingham, 29 November 2023
Online: via Zoom

 

We are looking forward to welcoming you to the annual SeerPharmaUK Symposium: Showcasing Industry-driven GDP Compliance (29 November 2023). We have a range of speakers from industry who are going to be sharing their challenges & solutions to problems & issues within the pharmaceutical supply chain.

AGENDA

Driving Compliance –
The Role of the Responsible Person

Carol McAuley, Ethigen Ltd

Exploring the role of the Responsible Person role looking at examples of some of the challenges faced and how to overcome these.

About Carol McAuley

Carol Joined Ethigen Ltd in September 2019 as Senior Responsible Person. Carol started working in the pharmaceutical industry in 1999 first with the Ministry of Defence and then with AAH Pharmaceuticals Ltd. Carol spent 2 years working in Merck in QC Testing before moving back to Wholesaling. Carol has held senior roles in Quality Control, Quality Assurance and as Responsible Person.

Carol is passionate about driving compliance and continuous improvements. She prides herself in leading by example in all aspects of the role.

Global risks associated with temperature controlled Pharmaceutical Transport

Jenna Cordery, Geodis

Taking a different perspective and looking at risks associated with both ambient and cold chain temperature-controlled transport with a case study on a high risk and difficult route.

About Jenna Cordery

Jenna joined Geodis Freight Forwarding UK in 2017 and works as the company’s Responsible Person and Quality Manager, having previously worked in community & hospital pharmacy. Jenna specialises in pharmaceutical logistics, temperature management and process-controlled distribution. Jenna has a strong focus on the application of quality management principles, especially Quality Risk Management, to international pharmaceutical freight movement.

No one size fits all –
Validating your passive packaging

Josie Morris, Woolcool

With such a big reliance on passive packaging to maintain labelled storage conditions this session looks at the different stages in the qualification/validation process, the common myths and the importance of validation with some top tips.

About Josie Morris

Josie is MD at Woolcool, founded in 2009. Designing and Manufacturing in the UK, they are leading innovators in their sector, producing insulated packaging using Sheep Wool, providing a sustainable alternative to Polystyrene.

Woolcool achieved B Corp certification in 2020, promoting business as a force for good, an ethos the company is passionate about, ensuring that both people and planet are taking into account when making business decisions. Josie is a leading advocate for creativity, diversity and the development of strong cultures within businesses. In 2021 she was awarded an MBE in The Queen’s Birthday Honours List for services to Manufacturing and the Environment, and became a Deputy Lieutenant of Staffordshire in 2023.
She is involved in a number of local, national and international engagement groups including being part of the ICC SME Champion Group, WTO Business Advisory Group, sitting on the Staffordshire Chambers of Commerce Board, and as a DBT Export Champion. She also sits as a trustee for a number of charities in the area.

What’s up?

MHRA Speaker Terence Madigan (Senior GDP Inspector)

Terence Madigan through his interaction with the wide range of companies, systems, processes will be providing examples of compliance solutions he has seen within the industry with a comparison of successful and some not so successful systems.

About Terence Madigan

Terry Madigan is a Senior Good Distribution Practice Inspector with fourteen years’ experience in this team at the Medicines and Healthcare products Regulatory Agency. His previous career was in large and small pharmaceutical manufacturing companies, latterly with nine years in quality assurance teams. These roles provided exposure to a wide variety of problems faced within industry and various means to overcome them. In this presentation, Terry will share examples of solutions he has come across, some more successful than others.

Innovation, digitalisation, tech within the supply chain

Andrew Portess, Alloga

Andrew will be looking at the approach being taken by a wholesaler to assess how changes and advancement in technology can help support systems and processes in the pharmaceutical wholesale supply chain.

About Andrew Portess

Andrew Portess has worked in the pharmaceutical industry for 17 years and is currently Director of Quality within an organisation which provides pharmaceutical logistics, distribution and other value adding services to manufacturers and Marketing Authorisation Holders.  In his current role, Andrew has a wide range of quality and regulatory responsibilities covering pharmaceutical pre-wholesale (including secondary packaging operations within a licensed GMP facility), pharmaceutical wholesale distribution and clinical homecare.  A Responsible Person since 2009 and more recently, Responsible Person (Import), Andrew has a wealth of experience in Good Distribution Practice and the development of the Quality Management System to support, and demonstrate, compliance to Good Distribution Practice.  In recent years Andrew has played a significant role in the development of the Quality Management System and operational processes to support the distribution of Covid-19 vaccines including thaw labelling, repackaging, and final mile delivery.

Everyone’s a critic –
process review & improvement in GDP

Alan Bentley, SeerPharma UK

Having recently left the MHRA, Alan will be exploring the requirement and importance of self-inspection, looking at the process and suggested improvements to ensure robustness and effectiveness.

About Alan Bentley

Alan began his career in the pharmaceutical industry in the early 1990s working in a range of roles from pre-clinical research to full scale manufacture, focusing on quality and compliance. He quickly developed a passion for ensuring that medicines were safe and effective, and worked diligently to build his expertise in regulatory compliance and good practice.
In his last role as Lead Senior GDP Inspector at the MHRA, he played a critical role in protecting public health by ensuring that pharmaceutical products are distributed safely and securely. Alan is highly respected for his deep knowledge, his commitment to quality, and his unwavering dedication to protecting public health.

SeerSurgery

Q&A session between Seer Directors and MHRA Speaker

Opportunity for delegates to ask questions or pre-submit questions related to the topics covered with an opportunity for an open discussion with presenters, former MHRA Inspectors and MHRA Senior GDP Inspector.

Here’s what people have had to say about our Symposiums:

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An overall excellent symposium. The topics were very relevant, the speakers knowledgeable and articulate, and the delivery medium works very well.

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Very informative presentations . Great to share good practice

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Symposium was very good, some very specialist knowledge and it was good to have it from a wider industry perspective rather than just a regulators view of the world.

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Well organised symposium with great speakers.
A lot of GMP specific content and case studies that would not have applied to most attendees but still a useful session.

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Symposium was very interesting and informative. Lot to learn and absorb during the presentations. The best part was being remote. At your comfort, no need to travel or book a hotel and saved running around. Saved money and trouble.

Fantastic idea and well done for organising a wonderful event.

All the best for future!

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Yesterdays symposium was my first exposure to Seer pharma “Gold standard” training and I found it to be very helpful indeed.

I have a shared opinion with many colleagues from other companies that the MHRA are not very approachable (and often contradictory) which makes genuine attempts to improve very difficult.

Your Symposium was far more like the open form discussion and honest opinions needed with in the industry. Presentation followed by a decent amount of question time is the way to go. Please always make time for questions and answer sections after each segment.

I look forward to participating in more Seer Pharma events in future.

Thank you all