webinar Archives - European Industrial Pharmacists Group (EIPG)

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

Webinar: Oral Colon Drug Delivery – Design Strategies

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EIPG webinar

Next EIPG webinar is to be held on Wednesday 21st of February 2024 at 17.00 CET (16.00 GMT) in conjunction with PIER and University College Cork. Anastasia Foppoli, will discuss on the various approaches and the general aspects relevant to the design and technological features of colon drug delivery systems, for the local treatment of inflammatory bowel diseases the control of colonic bacterial growth and the improvement of the bioavailability of orally administered polypeptides and proteins.

Increasing interest is directed to delivery systems able to control the site of release. In this respect, colon drug delivery has been suggested for the local treatment of inflammatory bowel diseases, the control of colonic bacterial growth and the improvement of the bioavailability of orally administered polypeptides and proteins. Various approaches have been attempted including the use of prodrugs, coatings degraded by microflora enzymatic activity, and polymeric coatings which dissolve at specific pH. Another strategy relies on the exploitation of the relative constant small intestine transit time of pharmaceutical dosage forms. This talk includes the rational basis for various approaches, the general aspects relevant to the design and technological features of colon drug delivery systems, together with their classification and definition.

Anastasia Foppoli is Associate Professor at the School of Pharmacy, University of Milan.
After graduating in Chemistry and Pharmaceutical Technology at the University of Milan in 1998, she earned a PhD from the University of Cagliari. In 1999, she attended the School of Pharmacy of the University of Minnesota as a visiting scientist, dealing with the study of solid-state properties of drugs and excipients. She is the author of more than 60 publications, including research papers, reviews, book chapters and patents in the drug delivery area, and presented numerous lectures at national and international conferences. Her current research interests, within GazzaLaB Research group, concern the design and preparation of conventional as well as modified release oral dosage forms. She serves on the Editorial Advisory Board of Journal of Pharmaceutical Sciences (Elsevier, Amsterdam, NL) and Pharmaceutics (MDPI, Basel, CH), and is peer reviewer for several major journals in the field of pharmaceutical technology. She is member of SITELF, SCI, CRS Italy Local Chapter and AFI.

By the end of this webinar, you will be able to:

  1. Understand the rational for colon delivery.
  2. Define the various physiological determinants to the design of colon delivery systems.
  3. Compare the different approaches proposed, criticalities and limitations.
  4. Be informed on well-established and emerging technologies involved in the manufacturing of colon delivery systems.
  5. Recognize the possible regulatory impact of colon delivery systems

Please register by filling out the Registration Form. Keep a record of the streaming details of the event that will be shown on your screen at the time of your registration.


Webinar: Building a healthier and more environmentally sustainable future

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EIPG webinar

Next EIPG webinar is to be held on Thursday 26th of October 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Kirsty Reid, Director for Science Policy at EFPIA, will discuss the various proactive initiatives and reactive activities undertaken by industry forming the basis behind building a healthier and more environmentally sustainable future within the healthcare sector. Kirsty holds a PhD in biology and for the past 18 years she has worked closely on research, EU public and regulatory affairs covering alternatives to animal testing, environment, health, safety and sustainability issues.

The European Green Deal, launched by the Commission in December 2019, is a package of policy initiatives, which aims to set the EU on the path to a green transition, with the ultimate goal of reaching climate neutrality by 2050. The pharmaceutical sector operations, the supply chain, pharmacies and patients will be impacted by the European Commission’s Green Deal initiative which focuses on climate, zero pollution, chemicals, and circular economy. Furthermore, there are ongoing decisions taking place to restrict certain substances or technologies which can potentially disrupt continuity of supply for specific products or platforms. The pharmaceutical package published on the 26 April, specifically calls out these legislations linking them to the environmental risk assessment of medicinal products.

At the end of this webinar attendees will be able to:

  1. Appreciate the April 2023 Pharmaceutical Package in relation to the European Commission’s Green Deal.
  2. Discuss the multiple ongoing actions to reduce emissions.
  3. Assist in the development of initiatives for your company’s Environmental Risk Assessments of medicinal products.

Please register by filling out the Registration Form. Keep a record of the streaming details of the event that will be shown on your screen at the time of your registration.


The Interface between Pharmaceutical Products and Medical Devices from a Product Development perspective

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EIPG webinar

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.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


Webinar: Pharmacovigilance as a specialization and the role of the Pharmacovigilance Risk Assessment Committee (PRAC)

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EIPG webinar

Next EIPG webinar is to be held on Wednesday 31st of May 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Sofia Trantza, a pharmacist with long experience as a Qualified Person for Pharmacovigilance in the Pharmaceutical Industry, currently representing Greece at the European Medicines Agency (EMA) as a member of the Pharmacovigilance Risk Assessment Committee (PRAC) will present the role and the procedures of the latter as a European body responsible for providing recommendations to EMA on any questions relating to pharmacovigilance activities in respect of medicinal products for human use.

According to the World Health Organization (WHO) pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. During the pandemic, this science went more popular than ever, and many people got familiarized with it. A very important role at the activities of this speciliazation plays the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).

Webinar attendees will gain understanding of:

  1. What is pharmacovigilance and what it represents for the public health.
  2. The process of reporting adverse reactions at national and at European level.
  3. The main activities and procedures in this discipline.
  4. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).
  5. The role and the responsibilities of PRAC Committee.
  6. The processes that PRAC is engaged in and how the work of this Committee is reflected in these processes.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


Webinar: ICH Q12 Product Lifecycle Management – open road or dead end?

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Next EIPG webinar is to be held on Tuesday 18th April 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Graham Cook, former Pfizer’s Quality Intelligence and Compliance Information team leader and chair of EFPIA’s Manufacturing and Quality Expert Group (MQEG) will explain the context for the development of the ICH Q12 guideline on Product Lifecycle Management.

The ICH Q12 Product Lifecycle Management guideline reached step 4 in the ICH process in November 2019 – where are we with the adoption of this guideline? This webinar will provide an overview of the content, and discuss the opportunities and implications for implementation of Q12 by industry and regulators.

Graham Cook is a pharmacist with a Ph.D. in pharmaceutics. He was appointed to the British Pharmacopoeia Commission between 2010 and 2021 and chairs the Medicinal Chemicals (MC2) Expert Advisory Group and the Analytical Quality by Design Working Party. Between 2012-2018 he was Chairman of the American Society for Testing Materials (ASTM) International E55 Technical Committee developing pharmaceutical manufacturing standards and continues to serve as a member of the E55 Executive Committee. He was a past chair of Pfizer’s Quality by Design Council and previous roles include Technical Director supporting Wyeth Europa Manufacturing and External Supply, and Director Formulation Development for Wyeth Consumer Healthcare (Richmond, Virginia, USA).

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


Comments to the draft ICH guidelines Q2(R2) and ICH Q14

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by Giuliana Miglierini

The public consultation on the two draft guidelines ICH Q2(R2) on the validation of analytical procedures and ICH Q14 on analytical procedure development closed at the end of July 2022.The European Medicines Agency published in August two documents summarising comments received (ICH Q2(R2) and ICH Q14).

Many industrial organisations contributed to the consultation with their point of view on the two draft guidelines. In the next phase of the procedure (step 3 of the ICH process), comments will be reviewed by the ICH Q2(R2)/ICH Q14 Expert Working Group (EWG). We summarise for readers some of the main comments received from industrial stakeholders. A webinar organised byEIPG on the implications and opportunities of the revision of ICHQ2 and the ICHQ14 was presented by Dr Phil Borman, Senior Fellow & Director Product Quality at GSK on 15thJune 2022 (recording and slides are available at the webinars page of EIPG’s website).

Key principles from the EIPG’s webinar

During the webinar, Dr Borman gave a comprehensive picture of the process of Analytical Quality by Design (QbD). The systematic approach to method development starts with the identification of the predefined objectives (Analytical Target Profile, ATP). The understanding and control of the analytical procedure are at the core of the process, and they should be pursued according to principles of ICH Q8. Analytical QbD covers both the drug product (ICH Q8) and the active ingredient (Q11). This means that a similar framework to ICH Q8 and Q11 can be applied also for analytical procedures. The ATP is made up of the sum of performance characteristics, precision, range (including sensitivity), and bias/accuracy.

According to ICH Q2(R1), published in 1994, the objective of validation of an analytical procedure is to demonstrate its suitability for the intended scope. Revision of both guidelines started in 2019, based on a Concept paper published in 2018. ICH Q2(R2) covers the validation of the analytical protocols and reports, while ICH Q14 refers to the development of the analytical procedure and its lifecycle management.

Key features of the new drafts include the fact that no additional expectations / mandated requirements for pharmaceutical analytical scientists are present, the possible use of “enhanced approaches” and the clear link between performance characteristics and their related criteria and the validation study. The Q2(R2) guideline shall apply to both small molecules and biologics and includes the possibility to use prior knowledge (e.g., from development or previous validation) as a part of the validation exercise. Assay for the determination of robustness can be conducted, for example, during development. Other key features highlighted by Dr Borman include the possible use of Platform analytical procedures to reduce the number of validation tests and the possibility to use any type of calibration model (including multivariate calibration).

The expected benefits refer to the possibility to reduce the existing burden associated with post-approval changes to analytical procedures and the use of Established Conditions.

As Dr Borman explained, the ATP could form the basis of a Post Approval Change Management Protocol (PACMP), thus favouring the reporting of changes between technologies at a lower reporting category. A more performance driven and flexible approach to validation is expected following the entry into force of the new ICH Q2(R2) guideline. The selection of validation tests shall be based on the concrete objective of the analytical procedure.

Comments to ICH Q2(R2)

The overview of comments relative to the draft ICH Q2(R2) published by EMA consists of a 72-page document, divided into a first section containing general comments and a second focused on specific comments.

APIC, representing manufacturers of active ingredients and API intermediates, focused on the fact that “uncertainty is not part of the validation whereas it has a reality in practice and part of the discussion between laboratories”. The measurement of uncertainty is also considered linked to the Total analytical error (TAE), a concept that would not be adequately addressed in the guideline.

EFPIA, on behalf of the biopharmaceutical industry, asked for a better connection between the two guidelines ICH Q2 and Q14, starting from the alignment of the respective titles. Improved consistency in the use of some terms was also suggested (e.g. ‘performance criteria’). Improved clarity and greater flexibility should be applied to the concept of working and reportable ranges. The association also asked to provide more examples for multivariate analytical procedures using different models to facilitate the understanding of their validation and lifecycle management.

Medicines for Europe, representing manufacturers of generic and biosimilars, asked to provide a more specific methodology for reportable range validation. The association requested some clarification about the possibility of using the minimal requirements of the performance characteristics for the addendum method validation strategy.

The European Association of Nuclear Medicine (EANM) focused its intervention of radiopharmaceuticals, a class of substances that should be considered a special case and therefore be excluded from the scope of the guidance. The request assumes that other approaches different that those discussed may be applicable and “acceptable with appropriate science-based justification”. The same request also applies to the draft ICH Q14 guideline. The EANM contribution also highlighted aspects specific to radiopharmaceuticals that should be considered, including the strength of the radioactivity content, the unavailability of radioactive standards of the active substance, and the need of specific techniques for radioactivity determination. The suggestion is to refer to the specific guideline on the validation of analytical methods for radiopharmaceuticals jointly developed by the EANM and the EDQM.

According to the International Society for Pharmaceutical Engineering (ISPE), there are many sections of the draft Q2(R2) guideline that may pose challenges due to lack of alignment and fragmentation of contents. A revision of the structure is thus suggested, together with the harmonisation of terms with those listed in the Glossary. ISPE also highlighted the opportunity to better clarify the distinction between validation elements and recommended data applicable to multivariate analytical procedures vs traditional analytical methods.

The ECA Foundation/European QP Association reported a very critical position on the two draft guidelines, clearly stating that ICH Q2 and Q14 should integrate with one another. According to ECA, the corresponding US guideline “USP <1220> is far superior”. Many of the points reported above with respect to the general section of the overview are discussed in more deep detail within the part of the document listing specific comments.

Comments to ICH Q14

The same structure of the document also applies to the 54-page overview summarising the results of the consultation on ICH Q14 guideline.

According to the Plasma Protein Therapeutics Association (PPTA), representing manufacturers of plasma-derived and recombinant analog therapies, the draft would be too focused on chemical methods, with just a residual attention to biological methods.

APIC asked for improved discussion of the capability (and uncertainty) of the method of analysis, a fundamental parameter to assess its appropriateness for the intended use within the defined specification range. According to the association, more specific reference should be made in relation to development data that can be/cannot be used as validation data.

ISPE suggested adopting a more detailed title for the guideline; something similar has also been suggested by EFPIA. ISPE also addressed the issue of reproducibility, that may be influenced by external factors across multiple laboratories. Multivariate analysis is also discussed, suggesting adopting additional requirements for the multivariate elements while maintaining the same approach to other analytical procedures.

EFPIA would prefer to avoid the use of the term “minimal” in favour of other expressions denoted by a less negative connotation (e.g., traditional, suitable/historic, classical, fit for purpose) with reference to the validation approach. The availability of training case studies is considered important to support the alignment between industry and regulatory agencies on expectations for regulatory change management, especially with reference to multivariate models. EFPIA asked that the paragraph discussing the relationship between ICH Q2 and Q14 should not address what should be submitted to regulatory agencies. Discussion of OMICS methods used in quality control of complex biological products should be included in the annexes.

ISPE asked to avoid reference to geographic regions, as the final goal is to reach harmonisation. A clearer statement of the scope would be advisable (a possible example is provided), as well as a better linkage to the ICH Q12 guideline on pharmaceutical product lifecycle management.

Specific comments include the suggestion of the PPTA to define all acronyms at first use in text and to include them in the Glossary. According to Medicines for Europe, it would be advisable to add characterisational assays (other than release/stability) for biosimilars. Furthermore, the scope of the guideline should focus on the risk assessment and availability of the analytical knowledge needed to select the most appropriate method for a specific application. Activities deemed to the submission of the regulatory CTD dossier should remain confined to the complementaryQ2 guideline.


Webinar: The impact of pharmaceuticals on the environment

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At the next EIPG webinar to be held on Wednesday 9th November at 17.00 CET (16.00 GMT) in conjunction with PIER and University College Cork, Bengt Mattson will present the impact of pharmaceuticals on the environment and what industrial pharmacists can do to help decrease the potential environmental impact.

Understandable concerns have been expressed regarding the presence of pharmaceuticals in the environment. Environmental protection contributes to safeguarding the health and safety of future generations. However, medicines play a critical role in ensuring a high level of public health.

Bengt has been the co-chair of the European industry’s Inter-Associations Task Force on Pharmaceuticals in the Environment for the past 8 years. He will discuss R&D initiatives, which influence green manufacturing and design safe, rational and effective use of medicinal products and the correct disposal of any unused or expired medicines.

The competence of industrial pharmacists in participating in these initiatives will be discussed.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


Webinar: Implementation of Contamination Control Strategy Using the ECA template

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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.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.

  • European Compliance Academy

 


Webinar: Contamination Control Strategy, an Implementation Roadmap

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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.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.

 


Webinar: Implications and Opportunities of ICHQ2(R2) and ICHQ14

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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.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.