Product development 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

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: 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.