26 April 2023 Seminars

9:15 am - 10:00 am

Challenges of Cold Chain Product in The Global Supply Chain

Speakers

9:15 am - 9:55 am

How to Effectively Manage a Remediation Programme

Speaker

  • Giby George MD, Senior Consultant and QP - GMP Healthcare
9:15 am - 9:45 am

IPEC Excipient Information Package and the New Sustainability Chapter

Speaker

9:15 am - 9:35 am

Safety Considerations in Manufacturing Pharmaceuticals

Speaker

9:15 am - 9:35 am

Screening of Pharmaceutical Polymorphs

Polymorph expert Ruwanthi Gurusinghe will talk Custom Pharma Services' approach to the screening of Pharamceutical Polymorphs.

More than 50% of commercially available drug candidates have more than one polymorphic form. Each morph may show differences in their physicochemical properties such as dissolution rate, bioavailability, physical and chemical stability. Various mechanical and environmental factors may cause unintentional transformations between different polymorphs. The presentation will cover:

An overview to the polymorphism.

  • Factors which affect polymorphic transformations.
  • The impact of polymorphic transformations in pharmaceutical compounds.
  • The importance of identifying the ideal polymorphic phases of drug compounds.
  • Polymorph screening techniques including X-ray crystallography, thermal methods, spectroscopic and microscopic.

Speaker

9:15 am - 10:30 am

Workshop: Helping to Secure the Pharmaceutical Excipient Supply Chain

Back in 1998, the World Health Organisation (WHO) stated that there were more than 500 deaths worldwide in the previous 60 years caused by use of falsified excipients. Since then, even very recently, further examples have occurred within the supply chain with dramatic impact caused for example by criminal activity, contamination, mislabelling, or upgrading of industrial grade material manufactured under non-GMP conditions.

As a result, the supply chain of pharmaceutical starting materials, in this case excipients, has been identified by regulators and industry as an important part of medicinal product safety. In a globalised world, excipients are supplied across continents and handled by an increasing
number of different parties. The increasing complexity of the global supply chain brings with it an increased risk in excipient security.

This workshop will seek to show how all parties within the supply chain can be supported (e.g. pharmaceutical excipient manufacturers, distributors, traders, brokers, re-packers,
carriers, warehouse providers) and detail some tools which are available to ensure supply chain security and support global drug safety.

Format:

Hear from experts on what’s required to adequately secure the storage and distribution of excipients and join in the discussion as to how this can be demonstrated to the satisfaction of all parties involved. The session has these key objectives:

  • To understand that as far as pharmaceutical excipients are concerned, concerns around supply chain security have not gone away.
  • There should be controls in place at each interface to ensure excipient security
    upstream as well as downstream within the supply chain.
  • With increasing complex supply chains, there are tools including third party certification schemes to complement your knowledge of supply chain pedigrees.

Having registered to attend Making Pharmaceuticals, or Distributing Pharmaceuticals, register your place on the workshop HERE

Speakers

9:35 am - 9:55 am

Pharmaceutical Supplier Qualification

Speaker

  • Richard Coe GDP Responsible Person - Protogen Consulting
9:35 am - 9:55 am

Raman Imaging – Not Just a Powerful Research Technique But Also a Fully Validated QC Tool

Speaker

  • Dr Adam Holland Senior Product Manager, Raman and micro-PL spectroscopy - HORIBA
9:45 am - 10:15 am

The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products

Speaker

9:50 am - 10:10 am

Raman Spectroscopy Solutions for In Line and Off Line Monitoring

From raw material qualification, in-process monitoring to finished product analysis, Raman Spectroscopy offers time and cost savings for process and bioprocess quality control. Discover how you can optimize your bioprocess workflows with handheld and portable Raman analysers.

Speaker

9:55 am - 10:15 am

A-TEEM (Absorbance – Transmission Excitation Emission Matrix) – the Future of PAT and QC/QA in Biopharmaceutical Production

Speaker

9:55 am - 10:15 am

Engineers’ Role in Managing Third Party Engineering Service Contracts

Speaker

9:55 am - 10:15 am

Rapid Approval for Parallel Import Submissions

Speaker

  • David Guest Ex-MHRA Part-Time, Independent Consultant - Parallel Import Licencing
10:00 am - 10:45 am

GDP- Building and Maintaining an Effective QMS

Speaker

10:10 am - 10:30 am

Operational Excellence in Contract Manufacturing

Speaker

10:15 am - 11:30 am

Break & Exhibition

10:15 am - 10:35 am

Electronic Work Instructions – A Use Case for Digitalisation Technology

Speaker

10:30 am - 11:00 am

Break & Exhibition

10:35 am - 11:30 am

Break & Exhibition

10:35 am - 10:55 am

Lite MES – A Case Study for Agile Digital Manufacturing

Speaker

10:45 am - 11:30 am

Break & Exhibition

11:00 am - 1:30 pm

Workshop: The Future of the Pharma Industry and What it Will Take to Succeed

Overview:

In 2022 a new word just entered the Collins English Dictionary. ‘Permacrisis – an extended period of instability and insecurity’. This will present unique challenges and opportunities to everyone in the Pharma Industry. Important questions must be answered:

  • How will companies cut costs (by 30% +) and maintain compliance?
  • How will you turn ‘disruptions’ into business advantage?
  • What must you stop doing, start doing and do better?
  • How will you attract, retain, and develop the best talent?
  • How can you educate your team – without a budget?
  • How can leaders make the right decisions despite the pressure, stress, and high levels of uncertainty?

Format:

This will be a PowerPoint free zone! To achieve deep learning and personal development the session will be highly interactive and involve group work and problem solving. The session has three key objectives:

  • To examine the challenges you face and to answer all your questions
  • To summarize what it will take to thrive in a Permacrisis
  • To have fun and leave the session buzzing with new thoughts, ideas, and solutions

Session Duration: 2.5 hours

This workshop must be pre-booked, and by individuals who have already registered to attend Making Pharmaceuticals or Distributing Pharmaceuticals.  Applicants will be notified 2 weeks before the event whether they have a place on the workshop.

Please book your place HERE

Speaker

11:30 am - 12:30 pm

Generation Logistics: Securing the Future of the Logistics Profession

Speakers

11:30 am - 12:30 pm

KEYNOTE ROOM A: Making a Covid 19 Vaccine During a Pandemic – A QP’s Perspective

Richard Tarrant was responsible for the final QP certification of the first batch of COVID-19 vaccine to enter clinical trials in Europe, the Oxford-AstraZeneca vaccine, and provided various support in efforts relating to material supply for clinical trials and emergency use authorisation.  In this talk, Richard will discuss the role of a clinical trial QP and how the small team at the Clinical BioManufacturing Facility (CBF) in Oxford were able manufacture, QP certify and release clinical trial material so rapidly and the various challenges encountered up until the point of emergency use authorisation.

Speaker

  • Richard Tarrant Contract Consultant & Qualified Person (QP) - RTMP Consultancy Ltd
12:30 pm - 2:00 pm

Break & Exhibition

1:30 pm - 2:00 pm

Break & Exhibition

2:00 pm - 2:20 pm

Amorphous Solid Dispersion Formulation and Compaction Process Optimization Using Quality by Design Principles and Tools

Speaker

2:00 pm - 2:20 pm

Applying for a Wholesale Distribution Authorisation (WDA(H))

Presentation looks at exploring the benefits and requirements of holding a pharmaceutical wholesale licence, giving an overview of basic requirements to get set up and maintaining a wholesale licence alongside other business activities.

Speakers

2:00 pm - 2:20 pm

Bio-decontamination Procedures According to the Latest ANNEX – Use of VHP Generators

Speaker

2:00 pm - 2:20 pm

Capsule to Tablet: Excipient Choices for a Flexible Formulation Strategy

Speaker

2:00 pm - 2:20 pm

Innovative and Disruptive Cell Transportation and Storage of Medium Product

CellShip® is a novel and potentially disruptive cell transportation and storage medium developed through a highly successful three-year Knowledge Transfer Partnership (KTP) between Life Science Group (LSG) and Coventry University. The Knowledge Transfer Partnership (KTP) is a national programme, partly funded by Innovate UK, designed to help businesses improve their competitiveness and productivity through partnerships with universities.

The KTP between LSG and Coventry University was awarded the highest grade of “Outstanding” by the KTP Grading Panel for its achievement in meeting KTP’s Objectives.

CellShip® is a liquid buffer that allows for the transport of cells at ambient temperatures without the requirement for cryopreservation. This could allow for the shipment of hybridomas, primary cells and other cells between researchers at ambient temperatures while maintaining the integrity and effectiveness of the cells. This product could also be extremely disruptive for cell and gene therapy manufacturing, allowing cells to be delivered to the patient at ambient temperatures without apoptosis that occurs following freeze/thaw cycles. This would also mean that harmful cryoprotectants would not be required.

An important benefit to note is that the protocol requires minimal cell manipulation.

It also reduces the risk of contamination and improves efficiency within the laboratory. To date, Cellship® is validated for up to 120 h of transport/storage at ambient temperatures. It is a cost-effective, safe, novel, and viable alternative to the storage and transportation of cells using standard cryopreservation methods, a useful tool, not only for research purposes but potentially suitable for biomanufacturing and transportation of Advanced Therapy Medicinal Products (ATMPs).

 

Speaker

2:00 pm - 2:30 pm

The Qualification of Vehicles and Transport Route Validation

Speaker

  • Chris Martin Chris Martin, Director & Senior Consultant - Christa GDP Pharma Ltd
2:00 pm - 2:20 pm

Using the Three Pillars of 3D Printing to Support Pharma Manufacturing

Regardless of technology, there are always considerations for any manufacturing process to get the best from it. This unique presentation, delivered by an internationally recognised 3D print expert with 20 years of experience in 3D printing describes how transformative the power of 3D printing can be when applied correctly and how these same principles are already being adopted by the pharmaceutical industry to drive profitability, productivity, and business risk reduction.

Speaker

2:20 pm - 2:40 pm

An Introduction to Particle Size Analysis Basics for Pharmaceutical Ingredients and Formulations

Speaker

2:20 pm - 2:40 pm

How to Achieve Sustainable GDP Compliance

Speaker

  • Mark King Associate Director, Quality (QP, RP, RPi) - JensonR+ Ltd
2:20 pm - 2:40 pm

Screening and Scale-up Techniques for Pharmaceutical Multi-Component Crystalline Drugs

Speaker

2:20 pm - 2:40 pm

Trends in Microbial Monitoring of Air in Aseptic Manufacturing

Assuring successful aseptic manufacturing of sterile requires an understanding of the difficulties and limitations of test methods employed.
Various current methods are discussed as to their strengths and weaknesses.

Speaker

2:30 pm - 3:00 pm

Partnership in Pharmaceutical Industry Post Covid: Collaboration and Competition Relationship

Covid 19 pandemic changed the dynamics of pharmaceutical companies and how they operate. It facilitated the research-based alliances and changed the perception toward partnership in the industry. The need for collaboration between competitors obligated companies to maintain the balance between collaboration and competition. The distribution of new molecules in different countries and region requires new levels of engagement, mainly in emerging economies. Pharmaceutical companies are seeking to conduct partnership with local partners in different regions to minimise the cost of distribution. The partnership between companies can be assessed to create many opportunities for competitive learning between partners.

Speaker

  • Dr Radi Haloub Associate Professor: Biotech and Pharmaceutical Management - University College London - UCL
2:40 pm - 3:00 pm

Digital CMC: The New Paradigm for Drug Development

Speakers

2:40 pm - 3:00 pm

Effective Training in the Pharmaceutical Industry

An overview of the regulatory requirements for training. GMP and GDP expectations with regards to training. How these requirements can be achieved in practice. Evaluation of an individual’s training needs – what they know already and what they need to be trained in. How to evaluate training and its effectiveness. Different learning styles and catering for these in training sessions.

Speaker

2:40 pm - 3:00 pm

Emerging Technologies for Making Pharmaceuticals at the Point of Care

Speaker

  • Dr Dennis Doroumis Professor in Pharmaceutical Technology and Process Engineering - University of Greenwich
2:40 pm - 3:00 pm

Understanding Regulations – Examining the Impact of the Biocidal Products Regulation (BPR) on Automated Airborne Disinfection Systems and Their Use in Aseptic Processing Facilities

Speaker

3:00 pm - 4:00 pm

Break & Exhibition

3:00 pm - 4:00 pm

Break & Exhibition