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Jul 2, 2017

Canada sets date for implementation of ICH E6 R2
The date shall be the 1st April 2018

Health Canada announced on it homepage the effective date for the new ICH E6R2 Addendum:

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China announced official ICH member
At the ICH Meeting in Montreal, China’s ICH membership was confirmed

The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June 2017. Among other decisions, the ICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a new Observer.

With these new parties, there are now 14 members and 23 observers, and full details are available on the ICH website

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UK’s withdrawal from the EU
EMA publishes first thoughts on implications and mitigating actions.

The Management Board endorsed the mandates of two working groups, one focusing on human medicines and one on veterinary medicines, that will explore options for a robust allocation of the workload across the European medicines regulatory network and ways to streamline work and further increase capacity in the network.

The Board endorsed a business continuity plan on the principles and the methodology that will help EMA prioritize its activities to make available the necessary resources to prepare for ‘Brexit’ and cope with a potentially significant staff loss.

EMA and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the UK's withdrawal from the EU.

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New action plan to support SMEs as drivers of pharmaceutical innovation
16 actions identified for implementation in 2017-2020

The European Medicines Agency (EMA) has published today an action plan for small and medium-sized enterprises (SMEs), which aims to foster innovation and support SMEs in the development of novel human and veterinary medicines.

SMEs are the backbone of Europe's economy. They represent 99% of all businesses in the European Union (EU) and provide two-thirds of total private sector employment. In the pharmaceutical sector SMEs are a motor of innovation and play a major role in the development of new medicines.

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Brookwood Academy launches “PV Training for All” Module
EFGCP GCP Discussion Group reviewed the first module

The module Basic PV for ALL is now available through this link:

The level 2 module “General PV” will soon be ready for another review.

The level 3 module currently in planning will focus on the Role of a national PV safety responsible and the additional aspects when this role is required as a local QPPV.

  • Level 1, PV for ALL, providing the information in how to identify and report safety issues to the PV contact.
  • Level 2, which is a general introduction that provides a common understanding of what PV is all about. This is suited for all those central and affiliate functions who interphase with PV or has activities /information of relevance for PV, and then maybe also for newcomers in PV.
  • Level 3, on what it takes to be local QPPV: This provides information on the role of a Local Safety Contact person and the added aspects and responsibilities when this role is required in form of a Local QPPV.

A big “thank you” to Lisbeth Tofte-Hemmingsen!

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FDA Updates Part 11 Guidance for Clinical Trials to Include Mobile and Wearable Tech
Public Comments are invited until late August 2017

The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting.

In a question-and-answer format, the guidance builds on the FDA’s 2003 Part 11 guidance, explaining how drug sponsors, contract research organizations, institutional review boards and other clinical trial entities must validate systems and audit trails to ensure data integrity.

The guidance suggests using a risk-based approach to validating individual technologies and calls on sponsors to thoroughly examine any product that provides clinical data, such as a wearable sensor that measures blood glucose levels.

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