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Jun 4, 2020

FDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials During the COVID-19 Public Health Emergency
On 29 May 2020 the FDA announced the availability of the free COVID MyStudies Application (App) for obtaining informed consent remotely.

The FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. The agency is providing this resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were in isolation rooms in health care facilities or could not travel to outpatient clinics.

FDA MyStudies is now referred to as "COVID MyStudies" in the Apple App and Google Play stores. The display name that appears underneath its icon after it has been downloaded is COVID19.

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Qualification of digital technology-based methodologies to support approval of medicinal products: Questions and Answers
On 27 May 2020 the EMA published the Q&A document on qualification of digital technologies.

This Q&A document highlights some of the key points to consider for the successful qualification of digital technology-based methodologies intended to support approval of medicinal products.

The principal focus of the document is to support Qualification of methodologies based on digital technologies in the context of medicinal product development. It may also be of assistance to applicants in the preparation for other types of EMA procedures and interactions, such as Innovation Task Force (ITF) meetings, scientific advice briefing books drafting, and preparation of Marketing Authorisation Applications (MAAs).

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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers
On 26 May 2020 the FDA published this Q&A Guidance for Industry.

This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

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Clinical Pharmacology and Pharmacokinetics: Questions and Answers
On 25 May 2020 the EMA updated the Q&A document on clinical pharmacology and pharmacokinetics.

The EMA added a new Q&A to section 4.12, Clarification on demonstration of bioequivalence for dabigatran etexilate and updated the Q&A to section 7.1, key pharmacokinetic considerations in the assessment of biosimilarity.

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EMA Updates EudraVigilance Registration Manual
On 18 May 2020 the EMA updated the EudraVigilance registration manual.

The EudraVigilance XCOMP (Test system) has been aligned with Production. For more detailed information on the EV XCOMP registration process, please refer to Section 7 of this manual.

To set-up a new organisation in EudraVigilance Production or XCOMP (Test system), a series of steps need to be followed:

1. A person within the organisation needs to be chosen as responsible for managing the organisation and its users in the EudraVigilance Production system. If the organisation is a marketing authorisation holder, the primary responsible person will be a Qualified Person for Pharmacovigilance (QPPV).

2. Register for an EMA user account in the EMA Account Management portal if you do not already have one. See section 2: User registration with EMA Account Management portal (IAM).

3. Check Organisation Management System (OMS). If your organisation is not present in OMS it will need to be registered. See section 4: Create a new Organisation.

4. Submit request to be registered as the responsible person for the organization. See section 3.2: EU QPPV or Responsible Person access request.

5. Complete organisation registration details in the EudraVigilance restricted area. See section 4.1: Finalise organisation information in EV Human Production and XCOMP.

6. Once the QPPV or responsible person is registered for the Production EudraVigilance system, they will automatically be registered for an XCOMP test account for the same organisation.

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European Medicines Agency Post-authorisation Procedural Advice for Users of the Centralised Procedure
On 18 May 2020 the EMA updated the questions and answers on extensions of marketing authorisations.

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication.

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Summary of Stakeholder Engagement to Support the Development of ICH E6(R3)
On 18 May 2020 the ICH announced the availability of the summary of the E6(3) stakeholder engagement approach.

The ICH-E6 GCP guideline is the reference standard for the conduct of clinical trials at a global level, including for non-traditional trial types, such as adaptive trials, trials utilizing master protocols, decentralized clinical trials and others in a clinical environment that is drawing on ever increasing data sources enabled by digitalisation of processes and information. In addition, while ICH-E6 is intended as a guidance for clinical trials that support regulatory submission of drugs, it may be applied to clinical trials in general. Patients, academic clinical researchers, and other stakeholders can provide unique and important insights into the design and conduct of clinical trials, as well as the ethical considerations that should be addressed.

ICH committed to stakeholder engagement with academic clinical researchers and patient representatives in its Reflection paper on Renovation of Good Clinical Practice and in the Concept Paper for the revision of ICH-E6. Understanding these groups’ perspectives as the working group develops ICH-E6(R3) will help to ensure that the guidelines are responsive to the needs of those conducting or participating in clinical trials. ICH considers the benefits from these engagements to be substantial and worth the effort and time to organise them.

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