by Giuliana Miglierini
The divergent road opened as a consequence of the Brexit, in January 2021, between the European Union (EU) and the United Kingdom (UK) is now converging again as for the possibility for UK researchers to participate to Read more
A concept paper from EIPG Advisory Group on Competencies vol.2, 2023
This paper is an update of the previous EIPG paper and intends to raise awareness of the changing requirements of the professional profile of Industrial Pharmacists for Pharmacists at Read more
by Giuliana Miglierini
The rapidly evolving role of artificial intelligence (AI) and its possible application in the pharmaceutical field led the European Medicines Agency (EMA) to publish a draft Reflection paper on the use of AI along the entire lifecycle Read more
A concept paper from EIPG Advisory Group on Competencies vol.2, 2023
This paper is an update of the previous EIPG paper and intends to raise awareness of the changing requirements of the professional profile of Industrial Pharmacists for Pharmacists at any stage of their career who intend to pursue careers in the Pharmaceutical Industry and those involved in the education of Pharmacists to update the education provided accordingly.
This paper is aimed at Pharmacists at all stages of their careers, including Pharmacy students, early career Pharmacists and Pharmacists working in a sector other than the Pharmaceutical Industry. The considerations presented are based on the collective expertise of the group. Therefore, this paper should be consulted as a starting point and is not a complete discussion of Pharmacist knowledge, competencies and skills nor a comprehensive overview of the Pharmaceutical Industry.
The EIPG with responsibility for the Pharmaceutical World, decided to continue the Project of the Advisory Group of Competencies. They used as a baseline document the first version of the position paper from 2020, in order to update the missing or outdated areas in the Pharmaceutical Industry. By examining some new trends and evolutions in drug science and technology, they explained the opportunities and challenges that are likely to arrive. All this information is intended for those at any stage of their Pharmacy career who want to understand their potential within the Pharmaceutical Industry.
The target of the project is to evaluate and determine the roles where the Industrial Pharmacist will work in the future and what knowledge, competencies and skills are needed to fulfill the requirements in these future roles. It is a shared understanding that there are gaps in the current curricula, but academia cannot cover all the needs of the Pharmaceutical Industry. For this reason, the Advisory Group have made some recommendations and proposals to recognize and fill those gaps. Hence, Pharmacists will have a clear view of the various roles in the pharmaceutical life cycle, and will be able to identify areas to develop on order to secure selected roles in the industry. This document may also be helpful in differentiating Pharmacists from other professions when applying for these roles.
To celebrate the 70th Anniversary of the foundation of the Belgian Association of Industrial Pharmacists (UPIP-VAPI) a Seminar on “The New Pharmaceutical Legislation” was held on 8th September in the European Parliament. The meeting was arranged in conjunction with the General Assembly of the European Industrial Pharmacists Group (EIPG) with attendance from participants of at least 15 European countries.
Frank Peeters, President of UPIP-VAPI opened the meeting and Alexia Rensonnet, a Board Member, described the new legislation as the largest reform in the past 20 years. The existing directive and regulations are to be replaced by new legislation with the objective of creating a single market to ensure all patients have timely and equitable access to safe, effective and affordable medicines whilst continuing to offer an attractive and innovation friendly market for suppliers.
Lilia Luchianov, Policy Officer at DG Sante – European Commission, said that the new legislation envisaged a leaner regulatory environment through simplification, regulatory modernisation and digitalisation. There will be access to both innovative and established medicines and incentives for innovation so that European companies remain globally competitive. Regulatory responsibilities will be shared between the EU and Member States. As well as changes to the General Pharmaceutical Legislation there will be changes to the Orphan and Paediatric legislation. Pre-authorisation support and a faster approval process including “targeted approach” rather than the current “one size fits all” are proposed.
The proposed reduction of protection for innovative products and the market launch conditions were questioned by several participants. Some of the current challenges for the Commission were said to be that pricing, reimbursement and procurement are a national competence.
In response to the current growing concerns on shortages, the Commission’s suggestions include the publication of an EU list of critical medicines, improved coordination of monitoring, earlier industry notification of shortages and withdrawals, improved industry shortage prevention plans, stronger coordination by the EMA and more legislative powers for the Member States and the Commission. During the discussion period Maggie Saykali, Director of the European Fine Chemical Group challenged the Commission to provide economic conditions for the manufacture in Europe of raw materials used by the pharmaceutical industry. Rather than dependence on China or India, European supply of raw materials would enormously improve security of supply of pharmaceuticals as well as improve worldwide environmental sustainability.
Par Tellner, Director of Regulatory, Drug Development and Manufacturing for the European Federation of Pharmaceutical Industries and Associations presented EFPIA’s views on the proposed revision to the pharmaceutical legislation. Whilst he welcomed the opportunities for regulatory modernisation such as simplification of the EMA structure by reducing the Scientific Committees from 5 to 2 and abolishing product licence renewals there are a number of challenges ahead. These include the notable reduction of research and development incentives, the added burden for industry to implement environmental risk assessments and the actual root causes of non-availability of medicinal products in the markets of Europe.
Jean-Paul Pirnay, head of LabMCT, Queen Astrid Military Hospital presented the past present and future of bacteriophage therapy. Wherever you find bacteria, you find phages which have been used since 1923 with the establishment of the Phage Institute in Tblisi (GEO). Although abandoned in the West many years ago, the Russian USSR has kept using phage therapy. Some isolated laboratories have been further developing and using phages and it has been shown that you need a handful of phages to target one bacterial spp.
Jean-Paul’s laboratory has helped establish a phage bank in a controlled environment. A single phage API can be produced according to a monograph. Individual phages can then be mixed together to target a particular bacterium. 100 seriously ill patients with resistant bacteria have been treated in 35 hospital of 29 cities and 26 phages were found to be needed. Eradication of the target bacterial infection was found in 61% of cases. In addition, phages were found to be synergistic when used with antibiotics. Jean-Paul considers commercially viable broad spectrum phage cocktails may be produced in the future.”
Geert Verniers (Lector SCM and Researcher BM-expertise center VIVES University) and his colleague described the use of Drones in the transportation of medicinal products,biological samples and tissues. With traffic congestion on roads causing gridlock around many hospital centres and personalised medicines needing urgent delivery from one area to another, the use of drones for professional transportation is compelling. Various significant points for consideration were discussed. These included the type of drone, drone pilots and Cargo Ports, the design of routes and the complexity of regulation, environmental impact, vibration problems and temperature control.
Following a lengthy discussion period, Frank Peeters thanked the speakers for their interesting contributions and all those responsible for this meeting being held in the European Parliament.
At the General Assembly held on 10th September in Brussels, voting took place for the positions of EIPG Treasurer and Vice-Presidents of Communications, European Affairs and Education and Careers.
The delegates present at this annual meeting elected Maurizio Battistini as Treasurer for the next two-year mandate. Giorgos Panoutsopoulos was elected to the position of Vice-President of Communications for the next 3 years, Anni Svala as Vice-President of European Affairs for 1 year and Astrid Thorissen as Vice-President of Education and Careers for 3 years.
Piero Iamartino presented the Past- Presidents award to Claude Farrugia for his exceptional contribution as President for two mandates. Jean-Pierre Paccioni was presented with a President’s Award for his valuable support with administrative operations in EIPG. In their absence from the meeting, an Outstanding Services award was made to Brigitte Saunier for her contribution to the financial management and a President’s award was made to Patrick O’Dwyer for his flawless technical support in the organisation of our webinars from University College Cork.
President Piero Iamartino together with the rest of the Bureau highlighted the main strategic objectives and confirmed their commitment to developing and promoting the position of the industrial pharmacist in Europe.
Next EIPG webinar is to be held on Monday 26th of June 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork and is entitled “The Interface between pharmaceutical products and medical devices from a product development perspective“ by Janet Halliday.
Janet qualified as a pharmacist and has spent her whole career in the Pharmaceutical Industry. After 10 years working in various technical roles in formulation and process development Janet moved into senior leaderships roles. This involved both Scottish based projects and leadership of a global team examining novel Drug Delivery technologies from academic groups and startups. Janet retired from Ferring Controlled Therapeutics in December 2022 and continues to pursue interests in startup companies and guidance for Life Scientists at the beginning of their careers.
The webinar will address the following topics: – An overview of the classification systems for devices in Europe and the USA; – Definition of combination products; – Challenges to consider when developing prefilled pens, polymer controlled delivery systems and patches; – Definitions of standard terminology that can cause confusion in product development teams; – Timings of development steps in Devices and Pharmaceutical products.
At the General Assembly held on October 15-16 in Athens, voting took place for the positions of EIPG President and Vice-President of Technical and Professional Development.
The delegates present at this annual meeting elected Piero Iamartino as President for the next three-year mandate. Rebecca Stanbrook was elected to the position of Vice-President of Technical and Professional Development. Brigitte Saunier completed her term of office as Treasurer and was thanked for her valuable support. Maurizio Battistini, Vice-President of European Affairs will act as EIPG Treasurer until the next General Assembly.
Claude Farrugia who has been President for two mandates and previously Vice -President of Communications was warmly thanked for his significant contribution to the progress EIPG has made in recent years as a reputable professional association recognised by the European Health Authorities.
The new President together with the current Vice-Presidents highlighted their main strategic objectives confirming their full commitment to developing and promoting the position of the industrial pharmacist in Europe.
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.