by Giuliana Miglierini
Digitalisation is rapidly advancing also in the regulatory field, as a tool to improve the efficiency and accuracy of processes used for the generation and use of data to inform the regulatory decision-making. To this instance, real-world Read more
The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 21st of October 2022 (16.00 CEST), on the implementation of Contamination Control Strategy (CCS) using the ECA* template. This is the second Read more
by Giuliana Miglierini
The implementation phase of the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched in January 2022 by the European Commission, started with the publication of the2022-2026 Workplan jointly drafted by the Commission, the European Medicines Read more
The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 21st of October 2022 (16.00 CEST), on the implementation of Contamination Control Strategy (CCS) using the ECA* template. This is the second presentation on the CCS, given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.
Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality. Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulate contamination.
The presentation explains the implementation of a CCS across a facility and deep dive into the ECA guideline on CCS. An example of CCS implemented by various manufacturers and the ECA CCS template will be presented. This will be followed by a discussion around the future challenges manufacturers may face with the principle of a holistic approach and how novel technology and data science combined with statistics may help in overcoming the future challenges.
The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 23rd September 2022 (16.00 CEST), on the implementation roadmap of Contamination Control Strategy (CCS). This presentation is given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.
Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality (EU Annex 2, EU Annex 14, USP1115, USP1116, FDA aseptic guideline, ICH Q10, Q11). The draft Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulates contamination.
The presentation explains the implementation of a CCS across a facility. It proposes an implementation roadmap to formulate and deploy a successful CCS. Also, it discusses the processes and environments that must be scanned to formulate a CCS. Then, the presentation proposes a method to make the strategy work as intended by implementing the correct control strategies. Finally, it discusses how a company can assess its CCS level over time and improve it. During the presentation, an online survey will be launched to assess CCS implementation practices amongst the attendees.
The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 15th June 2022 (17.00 CEST), on the implications and opportunities of the revision of ICHQ2 (on validation of analytical procedures) and the ICHQ14 (on analytical procedure development). Our speaker Phil Borman, Director and Senior Fellow at GlaxoSmithKline, pioneered the adaptation of Quality by Design principles to analytical procedures and currently co-leads the EFPIA ICH Q2(R2) and ICH Q14 guidance on Quality by Design, will explain why these guidelines are being developed and will highlight their implications and opportunities.
The revision of ICHQ2(R1): Validation of Analytical Procedures and the development of ICHQ14: Analytical Procedure Development reached the key ICH milestone of Step 2 publication for public consultation in March 2022. The combined topic Q2(R2)/Q14 represents an opportunity to provide guidance on how to apply enhanced development approaches (‘Quality by Design’) to analytical procedures and how to use the knowledge obtained to support routine use of procedures. Q2(R2)/Q14 will also have the potential to facilitate the selection or identification of development approaches that will reduce the risk incurred by post-approval changes to analytical procedures discussed in ICHQ12: Pharmaceutical product Lifecycle Management. This webinar will explain why these guidelines are being developed as well as highlighting the implications and opportunities.
The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 30th March 2022 (17.00 CEST), on Continuous Manufacturing of Pharmaceuticals. Giustino Di Pretoro a subject matter expert and drug product development lead will provide his expert practical experience of continuous manufacturing. Our speaker is Giustino Di Pretoro the Scientific Director at Janssen Pharmaceutica, a Johnson & Johnson Company. He is a subject matter expert and drug product development lead for continuous manufacturing, and coordinator for a series of academic collaborations within the field.
For more than 50 years, pharmaceuticals have been produced using a method known as “batch manufacturing,” a multi-step, lengthy process that usually involves the use of large-scale equipment. However, recent advances in manufacturing technology have prompted the pharmaceutical industry to consider moving away from batch manufacturing to a faster, more efficient process known as “continuous manufacturing”. The Regulatory Agencies are taking proactive steps to facilitate the pharma industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and to address many of the underlying causes of drug shortages and recalls. Our speaker will provide his expert practical experience of continuous manufacturing.
Our first EIPG Webinar of 2022 will be held in conjunction with PIER and University College Cork on Tuesday 18th January 2022 (17:00 CET). It is entitled: «Antimicrobial Resistance – How do we make Antibiotics Economically Viable again? ».
Our speaker is Professor Philip Howard, a hospital pharmacist who is the immediate past President of the British Society of Antimicrobial Chemotherapy. He is a member of the UK Department of Health’s advisory group on Antimicrobial Resistance & Healthcare Associated Infections and the NICE Common infections guidelines group, NICE living CoVID guidelines group and the NICE New models of antimicrobial funding committee. He is a spokesman for the Royal Pharmaceutical Society on Antimicrobials and for the Antibiotic-Action and British Society of Antimicrobial Chemotherapy charities. The webinar chairman is Dr Luigi Martini former Chief Scientist at the Royal Pharmaceutical Society.
Antibiotic sales during the golden era of antibiotic discovery of the 1960s and 1970s outstripped most other therapeutic areas. As soon as antimicrobial resistance became an issue, there was a focus on using them more prudently. Antimicrobial resistance (AMR) in the high-income countries is driven by over-consumption, so antimicrobial stewardship initiatives to avoid starting or stopping or de-escalating antibiotics as soon as possible have seen diagnostic scoring systems or point of care tests flourish. Other challenges seen are the lack of transparency in the supply chain, coupled with low prices and these have made antimicrobial shortages common. New antimicrobials are needed to combat AMR. The pharmaceutical industry should be able to play an important role in antimicrobial stewardship whilst still marketing economically viable new products.
As representatives of the European Union’s health community, we are united in our call for the United Kingdom’s association to Horizon Europe to be formalised as soon as possible.
Horizon Europe aims to tackle the major global challenges of our time but achieving this aim will be impossible without international collaboration. The COVID-19 pandemic has clearly highlighted the critical value of global partnerships to advance scientific discovery and innovation, especially where speed is of the utmost importance. The depth and strength of successful international collaborations resulting from the relationships built up over many years with the UK is long established.
We have all reaped the mutual health benefits of these collaborations. Together, we have significantly advanced health care across Europe, saving and improving citizens’ lives. Clinical trials, particularly on diseases with limited patient populations, have been heavily reliant on EU-UK collaboration, while close research and innovation partnerships continue to accelerate life-changing medical research.
Going forward, we must continue to work together in order to meet the challenges of our swiftly changing world. Our ability to respond to the threat of climate change and outbreaks of new diseases like COVID-19 has been greatly improved by close scientific and clinical partnerships across Europe. Knowledge and discovery do not stop at borders: the shared global challenges we face require joint solutions. Collaboration through the research framework programmes is a springboard to productive partnerships across the world.
As a community, we welcomed the provision in Protocol I of the EU-UK Trade and Cooperation Agreement for the UK to associate to Horizon Europe. The subsequent Q&A document from the European Commission provided us with confirmation that we could apply with UK entities for the first multi-beneficiary calls. Based on these reassurances, EU health research organisations have been working with UK partners on the understanding that they would shortly become full associate members. However, the absence of a clear timeframe for formalising UK association is now causing increasing concern. We notice too with regret that while the specialised committees for other policy areas are already established, the Specialised Committee on Participation in Union Programmes has not yet even had its first meeting.
This continuing uncertainty risks jeopardising current and future research partnerships, and time is fast running out. With the first Horizon Europe grant agreements nearing finalisation and new calls expected imminently, UK association must be formalised. Now is the time to act. Further delays or the spectre of non-association would result in a missed opportunity to tackle the major challenges of our time, diminish our collective research capabilities and weaken Europe’s position in the highly competitive global market.
Many profound and long-lasting EU-UK research partnerships are at stake. These are of high value to Europe as a whole – and to the world at large. We owe it to future generations in the EU and beyond to ensure that the new EU-UK relationship best serves them through research.
In November 2020, the Commission published a Communication on a Pharmaceutical Strategy for Europe. The Pharmaceutical Strategy identifies flagship initiatives and other actions to ensure the delivery of tangible results: https://ec.europa.eu/health/sites/default/files/human-use/docs/pharma-strategy_report_en.pdf As part of the implementation of the strategy, the Commission is evaluating the general pharmaceutical legislation and assessing the impacts of possible changes in the legislation as described in the relevant inception impact assessment.
This consultation aims to collect views of stakeholders in order to support the evaluation of the existing general pharmaceutical legislation and the impact assessment of its revision. A summary on the outcome of the public consultation will be published by the Commission services on the ‘Have your say’ portal. The Commission’s questionnaire is under consideration by our Bureau members and the link is as follows: https://forms.office.com/r/EUHkxBN3Sk. The deadline to participate in this consultation call is the 10th December.
The next EIPG’s and PIER’s webinar to be held on Thursday 18th November 2021 (17.00 CET) will be chaired and the subject introduced by Irene Gonzales-Conde, Board Member of AEFI (Spanish Association of Industrial Pharmacists).
The main speaker, Luciano Gambini has spent most of his working life in global R&D quality assurance, setting up internal policies for the quality of Investigational Medicinal Products (IMPs). He is the coordinator of the AFI (Italian Association of Industrial Pharmacists) working group on manufacture of IMPs.
There has been extensive debate about the Clinical Trial Regulation which finally enters into force on 31st January 2022. However, little has been discussed about manufacture of the IMPs. The aim of this webinar is to raise questions and provide preliminary answers to any differences between the current and new manufacturing and labelling requirements.
Over the last 20 years Physiologically – Based Pharmacokinetic (PBPK) Modelling and Simulation has developed and is now used extensively within Discovery and Development in the Pharmaceutical Industry. Its adoption has been driven by the availability of commercial software platforms and a realisation of the benefits to be gained including the potential to reduce the number of in vivo studies performed.
In EIPG’s and PIER’s next webinar, to be held on 21st October 2021 (17.00 CEST), Jonathan Brown will cover an introduction to PBPK modelling, what it is and how it can be applied to support Chemistry, Manufacturing and Controls (CMC) development. It will provide an overview of usage in oral, small molecule development, supported by examples from the areas of biopharmaceutics and formulation development. Current and potential future applications of PBPK modelling in Quality and Regulatory fields will also be discussed.