Posts by Anna Jurczynska

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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New tracking tool for EMA’s relocation to Amsterdam

05/03/2018 New tracking tool for EMA’s relocation to Amsterdam Tool gives transparent overview of main milestones and work stream deliverables*   The European Medicines Agency (EMA) has published a new tool showing the main milestones and deliverables for the Agency’s move to Amsterdam. Because of its important role to safeguard public and animal health in…

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Regulatory information – adjusted fees for applications to EMA from 1 April 2018

05/03/2018 Regulatory information – adjusted fees for applications to EMA from 1 April 2018 Fees expected to increase by 1.7% The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2018 Every year, the European Commission adopts…

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EMA: Evaluation of advanced therapy medicines

01/02/2018 Evaluation of advanced therapy medicines Updated procedural advice clarifies regulatory process for advanced therapy medicinal products The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of…

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EMA: Strengthened guidance on follow-up and risk management for ATMP developers

01/02/2018 Strengthened guidance on follow-up and risk management for ATMP developers Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation The European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management of advanced therapy medicinal products (ATMPs) for a three-month…

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