Posts by Anna Jurczynska

FDA Basics for Industry

  How do i know if my product is regulated by the FDA? It depends on what the product is and how it is marketed. For more information, see FDA’s general navigation guide for manufacturers of FDA-regulated products and start-ups. what should I expect during an inspection? FDA may conduct an inspection of your operation…

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Ten years promoting high-quality scientific research in paediatric medicines

The second day of the workshop is reserved for discussions among the members of Enpr-EMA and its coordinating group. The coordinating group will define priority tasks for 2018–19 based on the feedback received from stakeholders. Individuals interested in attending the first day of the workshop are invited to send a completed registration form to enprema@ema.europa.eu before 28 May 2018.…

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Updated rules for clinical development of vaccines

26/04/2018 EMA launches public consultation on revised guideline on clinical evaluation of vaccines The European Medicines Agency (EMA) has released a revised guideline on the clinical evaluation of vaccines for a six-month public consultation. Stakeholders are invited to send their comments by 30 October 2018 to vwp@ema.europa.eu using the template provided in the guideline. Vaccination is one of the greatest breakthroughs in modern medicine.…

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Civil society representatives wanted…

Civil society representatives wanted for EMA’s Management Board and Pharmacovigilance Committee 30/04/2018 Submission deadline is 8 June 2018 The European Commission has launched a call for expressions of interest for civil society representatives to join the Management Board of the European Medicines Agency (EMA), as well as the Agency’s Pharmacovigilance Risk Assessment Committee(PRAC). This is an opportunity for civil society representatives to…

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EMA 2017 annual report published

02/05/2018 Report highlights major achievements and includes key figures The 2017 annual report published today provides an overview of the work of the European Medicines Agency (EMA) and highlights last year’s major achievements in protecting and promoting public and animal health in the European Union (EU). EMA’s annual report draws attention to some of the Agency’s main…

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The PharmaTrain Syllabus for Pharmaceutical Medicine / Medicines Development Science (Version 2.0) 2018

To all IFAPP National Member Associations (NMAs) and Individual Affiliates  We are pleased to introduce the 2018 PharmaTrain Syllabus (2018 Syllabus).*  IFAPP, The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine, together with The PharmaTrain Federation (PTF) and The Faculty of Pharmaceutical Medicine of the UK Royal Colleges of Physicians (FPM)  jointly sponsored…

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I AM IFAPP: JOHANNA SCHENK

Today we are starting a new section on the IFAPP website, recognizing the value and professionalism of relevant members of IFAPP who have greatly contributed to the growth and development of our Federation: “I am IFAPP”. The first person to talk to all of us and comment on her experience is Dr. Johanna Schenk, Past…

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FDA: E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

Guidance for Industry INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their…

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Support for industry on clinical data publication

Agendas, meeting reports, presentations, question-and-answer documents and available video recordings are provided on the meeting pages. Micro, small and medium-sized enterprises Micro, small and medium-sized enterprises (SMEs) are entitled to a free redaction tool license valid for a period of 12 months to allow companies enough time to prepare the final redacted version. The application…

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EMA: Human medicines highlights 2017

The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorization and post-authorisation applications for human and veterinary medicines that it evaluates. Click the link below to view the report. ema human medicines highlights 2017 This document was originally posted by the EMA here. 

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