The 16th Conference of Council of Europe Ministers responsible for Sport, organised in the framework of the Greek Chairmanship of the Committee of Ministers, will focus on the revision of the European Sports Charter and a specific highlight on Human Rights in Sport. It consists of five different sessions all held via an online video platform, spread out over a period of several weeks (see programme). The first two sessions took place on 5 November. The opening session (5 November at 10-11 a.m. CET) started with a video message from Secretary General Marija Pejčinović Burić which was screened at the beginning of the conference, followed by Miltiadis Varvitsiotis, Alternate Minister for Foreign Affairs of Greece, who made a live statement. A Leadership Dialogue (“Championing values in sport”) then took place, moderated by Council of Europe Director General of Democracy, Snezana Samardžić-Marković. Lefteris Avgenakis (Deputy Minister of Sport, Greece), Roxana Maracineanu (Minister of Sport, France), Christophe De Kepper (International Olympic Committee Director General), Alexandra Shelton (Olympic fencer) and Jonas Baer-Hoffmann, Secretary General, Global FIFPro took part in the debate. This session was open to the public/media and streamed live online, with an attendance of 320 people. The session also saw the launch of a new EPAS video, showing that sport must be accessible to everybody – it must be safe, fair, built on high ethical values, protective of human dignity and against any kind of exploitation of those involved in sport – the video is a call to all key stakeholders to act as a community in the interest of sport and society..
Council of Europe and OSCE discuss how to enhance anti-trafficking action in the light of the pandemic
National Anti-Trafficking Co-ordinators and Rapporteurs from over 50 countries across Europe, North America and Central Asia gathered online on 3 and 4 November 2020 for the largest annual meeting of its kind focused on human trafficking at the international level. The event, jointly organised by the Council of Europe and OSCE, focused on challenges posed by the COVID-19 pandemic to anti-trafficking responses.Participants underscored how the COVID-19 pandemic has created more favourable conditions for traffickers by exacerbating pre-existing vulnerabilities and creating new ones, pushing people in difficult economic circumstances into risky and exploitative situations. They shared promising practices in the prevention of human trafficking, the protection of victims, and the prosecution of traffickers amid the pandemic and highlighted the need for enhanced anti-trafficking action across all sectors.
Observatory on History Teaching in Europe: a new flagship project of the Education Department
GREEK PRESIDENCY OF CM - EDUCATION
On 12 November 2020, the Committee of Ministers of the Council of Europe decided to create the Observatory on History Teaching in Europe. Initially with 17 member States*, the Observatory will operate as an enlarged partial agreement. It will build on the Council of Europe's decades-long experience in history education, while complementing and strengthening its intergovernmental programme. The initiative for the Observatory was taken in May 2019, under the French Presidency of the Council of Europe ."It is a project for the future of young people that can help consolidate peace and European unity that is taking shape today", stressed Ambassador Marie Fontanel, Permanent Representative of France to the Council of Europe when the Committee of Ministers adopted the resolution establishing the Observatory. Together with the declaration on the education response to COVID-19, adopted by the European Ministers of Education on 29 October, the creation of the Observatory will also be an important legacy of the Greek Presidency of the Council of Europe and "a valuable tool in the fight against dangerous revisionism and attempts to falsify historical truth", as underlined by Miltiadis Varvitsiotis, Alternate Minister for Foreign Affairs of Greece. The Observatory’s main purpose will be to collect and make available, through a series of regular and thematic reports, factual information on the state of history teaching in all participating countries. The main aim will be to facilitate exchange of good practice and mutual learning. It will also serve as a platform for professional development and networking for European professional associations and institutes active in the field of history teaching.
(*) Albania, Andorra, Armenia, Cyprus, France, Georgia, Greece, Ireland, Luxembourg, Malta, Portugal, Republic of North Macedonia, Russian Federation, Serbia, Slovenia, Spain and Turkey.
Further progress made in ensuring vaccine preparedness
EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES AND HEALTHCARE
The first three Official Control Authority Batch Release (OCABR) guidelines for pandemic COVID-19 vaccines were published on the EDQM website on 6 November and will come into force on 12 November. These product-specific guidelines have been elaborated by a panel of experts from various OMCLs under the aegis of the EDQM and will facilitate OMCLs in meeting the legal requirements related to OCABR testing. They ensure a common approach to testing in all OMCLs throughout the EU/EEA and transparency for all users of the system. The guidelines are adopted only after consultation within the network and, where appropriate, after a public enquiry involving interested parties. The procedures and guidelines for running OCABR apply equally in all member states.The availability of these guidelines at an early stage will help anticipate the launch of the first vaccines and allow OMCLs and manufacturers to take the necessary steps to prepare for OCABR, thus preventing delays in availability while still ensuring their quality and safety. This is an important step in assuring independent control and to facilitate access to these important vaccines, which will be critical in the fight against the pandemic.
Youth Knowledge Hub on the impact of Covid-19 on the youth sector
Launched on 29 October, the Youth Knowledge Hub of the EU-Council of Europe youth partnership is an access and reference point for youth sector stakeholders, bringing together various research initiatives on this topic. It includes 80 references and their findings on how Covid-19 and related measures have impacted young people, youth organisations, youth policies and youth work at national and trans-national levels in Europe. It also contains briefings on the main topics and gaps identified, thus making it an invaluable tool to support policy- and decision-makers channel the findings into their work. The Knowledge Hub will be updated on a regular basis with further resources and analyses.
CDCPP The 9th session of the CDCPP (10, 12 and 13 November) had highlights including three thematic sessions with presentations by leading experts, the launch of the Manifesto on Arts, Culture and Freedom of Expression in the Digital Era and the exhibition concept “Free to Create, Create to be Free”.
EUR-OPA Major Hazards Agreement (Natural and technological disasters) The Joint Meeting of the Committee of Permanent Correspondents and Directors of Specialised Centres (DSC) was held on 3-4 November by videoconference. Recommendations: Enabling and protecting persons with disabilities during a viral or other pathogenic pandemic as well as another biological disaster; and Inclusion of migrants, asylum seekers and refugees in preparing for and responding to biological disasters, based on expert papers drafted in advance, were discussed with a view to their adoption in a written procedure, after appropriate national consultations. The Permanent Correspondents also held a preliminary exchange of views on the draft Medium-Term Plan 2021-2025 to be adopted at the 2021 Ministerial Conference. The Permanent Correspondents discussed and adopted a revised Programme of Work 2020-2021 and discussed with the Directors of Specialised Centres the outcomes of the Centres’ projects carried out in 2020 and proposals for projects for 2021.
The Steering Committee of the EU/CoE Joint Programme Quality Education for all in Montenegro met on 27 October to discuss the progress of project activities and supported the initiative of creating a Digital Democracy Classroom in pilot schools.
On 5 November, the working group on History Education held its second online meeting. The Group considered the development of the intergovernmental programme on history education, its relationship to the Observatory, and its relationship to Competences for Democratic Culture
HUMAN RIGHTS MATTER: Educate, Promote and Protect
From 3 to 8 November, 24 youth workers and youth leaders committed to human rights education and youth work, took part in an online Compass national training course on Human Rights Education organised by the Portuguese Red Cross (Youth section) in partnership with the Council of Europe, Amnesty International and the Portuguese Institute of Sports and Youth. The course resulted in some 20 local projects and partnerships for human rights education which will be followed up by the co-organisers.
European Youth Card
A webinar organised by the Greek Presidency of the Committee of Ministers on 5-6 November gathered youth NGO representatives, youth activists, youth card organisations, experts and researchers, as well as governmental officials and policymakers from all over Europe, both in Athens and online. Themes such as supporting young people, including youth workers and students, during the pandemic and digital youth work and youth services to help build resilient communities were discussed. The role of young people using the European Youth Card under the Council of Europe Partial agreement on youth mobility was a special priority for the event.
Certification of new Cultural Routes of the Council of Europe
EPA Cultural Routes
At its meeting of 7-8 October, the Governing Board of the Enlarged Partial Agreement on Cultural Routes of the Council of Europe awarded “Cultural Route of the Council of Europe” certification to two new networks:
thus bringing the programme to 40 certified Cultural Routes.
Manifesto “Free to Create, Create to be Free”
Marking the 70th anniversary of the European Convention on Human Rights (ECHR), Giuliana de Francesco, Committee Chair, unveiled a Manifesto on Freedom of Expression of Arts and Culture in the Digital Era, and a concept for a digital #exhibition called “Free to Create, Create to be Free” at the 9th Plenary Session of the Steering Committee for Culture, Heritage and Landscape (CDCPP) on 10 November.
EUROPEAN LANDSCAPE CONVENTION
Preparation of the Information Platform of the European Landscape Convention of the Council of Europe. The Platform is designed to facilitate access to information on work carried out for the implementation of the European Landscape Convention and its basic texts, regarding five topics: definition of landscape; landscape policies; landscape integration; international co-operation; exemplary projects.
15th Anniversary of the Faro Convention
At the Ceremony marking the 15th anniversary of the adoption of the Faro Convention, organised on 26 October by the municipality of Faro, Portugal, the Council of Europe’s Secretary General, Marija Pejčinović Burić, delivered an inspiring speech by video, emphasising the importance of the Faro Convention in ensuring active engagement by all actors, especially citizens and heritage communities, in the management of cultural heritage ( see short video)
TRAINING AND CAPACITY BUILDING
Right to Remember – a handbook for education with young people on the Roma Genocide The Youth Department’s educational resource for all those wishing to promote a deeper awareness of the Roma Genocide and to combat discrimination is now available in Hungarian and Russian. As well as educational activities, the publication contains information about the Genocide and its relevance to the situation of the Roma people today.
EYF consultancy service gets under wayFollowing the recent launch of a new consultancy service to offer advice to youth organisations struggling to remain afloat because of the Covid-19 pandemic, advice has been given to the first NGO to apply and five others will receive guidance in the coming days. This service is free of charge and is available for all youth organisations with EYF-funded activities. NGOs are encouraged to take advantage of this service which will be available until the end of this year.
The youth sector is at the Internet Governance Forum (IGF)Human rights questions such as data protection and security, artificial intelligence, internet regulations and policies, cybercrime, online hate speech and access to services, will be the main focus of a group of activists, including members of the Advisory Council on Youth, who are participating in the IGF online until 25 November. Youth participation in Internet Governance is a priority in the Youth for Democracy programme which aims to develop young people’s competences for influencing decision-making processes in youth e-participation and for promoting human rights online.
A new look for the EYCB lobby!The reception area of the European Youth Centre in Budapest (EYCB) and the fourth-floor conference zone have had a facelift! The EYCB has undergone some renovation work, financed by the Hungarian Ministry of Foreign Affairs and Trade, especially with a view to the upcoming Hungarian presidency of the Committee of Ministers (May-November 2021) when the Centre will play host to a number of activities.
The new ECML resource website - A guide to teacher competences for languages in education– was launched. The resource platform has been developed for teacher educators and those responsible for teacher education programmes. It provides an overview of frameworks and descriptions of language teacher competences in various contexts, as well as national and regional standards and guidelines. A workshop for ECML National Authorities – Governing Board, Nominating Authorities and Contact Points – will take place on 17 November. The focus of the event will be on helping member states become familiar with activities in the new programme 2020-2023 and to consider how to promote, implement and evaluate resources and capacity-building activities from the 2016-2019 programme.
Under the SIDA-funded project “Strengthening Democratic Citizenship Education in Albania”, 4 online focus groups were organised. Feedback was received on the findings of the two studies carried out within the project: on the level of Democratic Citizenship Education in the school curricula and on teacher preparedness to teach it. Representatives of Ministry of Education, Sports and Youth endorsed the reports’ recommendations.
In the context of the Swiss Development Co-operation-funded project "Education for Democracy in the Republic of Moldova", online training sessions were organised between 23 October and 10 November for 1200 civic education teachers on the competence-based civic education subject.
On 3-4 November, the Council of Europe organised a videoconference on Digital Citizenship Education Days as a contribution to the French Etats Généraux du Numérique. Some 250 participants from all over Europe considered the impact of digital citizenship on the changing structure of educational technology use as well as how the COVID-19 pandemic changed digital citizenship.
Recent new measures to slow the spread of Covid-19 have resulted in the closure of cinemas in several countries. The medium- and long-term consequences for the film industry in the member States are still uncertain. In these circumstances, the priority for Eurimages is to maintain fully the Fund’s functioning in order to help independent producers through this very difficult period.The Secretariat is currently evaluating the eligibility the co-production projects submitted on 20 October for the last call of the year. The online working groups with the national delegations for the assessment of the projects will take place during the month of December. On 23 October, the “Junior Co-production Market” at the youth-content focused Cinekid for Professionals event announced its winners including the recipient of the Eurimages Co-production Development Award, worth €20 000, which was awarded to the project “Tiger Martindale’s Survival Experts” to be directed by Pavel Gumennikov and produced by the company Baltic Pine Films (LV). Following calls for tender, Ernst & Young Advisory was selected to carry out a study on how Eurimages might best support the distribution of films receiving co-production support and Tatino, a consortium of experts, was commissioned to propose an innovative redesign of the Eurimages awards made to projects exploring new forms expression.
NORTH SOUTH CENTRE
As part of the #SolidAction campaign the North-South Centre launched a series of video-interviews which launch a reflection around international solidarity today, its scope, its values, its main agents and its effectiveness;
Preparations for the two main flagships events of the North-South Centre are underway: The XXV Award Ceremony of the North-South Prize will take place with a hybrid format on 2 December while the Lisbon Forum will be organised fully online from the 1 to 3 December.
This year’s Forum will be devoted to “Learning from our global challenges: Enhancing Solidarity” and, to address the main question, the Lisbon Forum will look into three specific problematics through concrete examples from the ground and three thematic workshops;
Following the cancellation of the Summer Universities 2020 (UYD and MedUni) and considering the current pandemic crisis, which is challenging traditional spaces for dialogue and accelerating the process of shrinking space for civil society, the North-South Centre organised the Meta University on 4 and 5 November. It counted on 163 participants from all over the world and served as a space to connect and re-connect among different organisations at global level while reflecting about the recent critical circumstances, sharing the current challenges and drawing plans for the future.
The North-South Centre participated in the second meeting of the 4.7 Policy Working Group of the Bridge 47 Network, on 2 November. The meeting was an opportunity to look back on what has happened in the last year at the level of the European Union and the road ahead, as well as delve a bit into the EU’s European Education Area policy area. Some updates about North-South Centre work were also shared, namely the upcoming Global Education Week and the expert online meetings.
DIRECTORATE OF HUMAN DIGNITY, EQUALITY AND GOVERNANCE
Launching of the 9th edition of the WFD: Can Democracy Save the Environment?
The Forum will be launched on 18 November by video message of: Ms Marija Pejčinović Burić, Secretary General of the Council of Europe; Ms Barbara Pompili, Minister for Ecological Transition of France; Mr Jean Rottner, President of the Region Grand Est; Mr Frédéric Bierry, President of the Departmental Council of Bas-Rhin; Ms Jeanne Barseghian, Mayor of Strasbourg. At 14.30, an expert workshop will discuss the main topics of the Forum. The experts will be Virag KAUFER, Senior Portfolio Manager Climate and Energy, Greenpeace International; Prof Dominique BOURG, Directeur de la publication La Pensée Ecologique ( https://lapenseeecologique.com/); Mr Aron CRAMER, CEO BSR (Business for Social Responsibility).
COMMITTEES, MONITORING BODIES, WORKING GROUPS
The Istanbul Convention and the Committee of Ministers’ recommendation on preventing and combating sexism were presented on 12 November at a webinar on “Cyberviolence against women”, organised in the framework of the joint EU/COE CyberEast project. The webinar was designed to encourage an interactive participation, and to facilitate information-sharing among participants, exchanging relevant experiences and good practices, and discussing challenges and opportunities amongst officials and policy-makers responsible for cybercrime, cybersecurity, violence against women and domestic violence, criminal justice authorities, civil society and academia.
Gender Equality Rapporteurs (GERs) and members of the secretariat of Council of Europe intergovernmental committees took part to a 2-days training session on gender mainstreaming, aimed at enhancing their capacity to mainstream gender equality, intersectionality and women’s rights in their overall work. Gender Equality Rapporteurs are appointed within steering committees and other intergovernmental structures of the Council of Europe to ensure the effective integration of a gender equality perspective in the policies and activities of their respective structures.
Launching of South Programme IVThe launching event of the South Programme IV will take place online on 23 November 2020. The event is aimed at presenting the objectives and challenges of the Programme, as well as ensuring its visibility among a wide public. A virtual panel will be dedicated to the issue of combating violence against women and will engage the key stakeholders of the region, in particular the Minister of Women, Family, Children and Seniors of Tunisia, the President of the National Commission for Lebanese Women, the President of the National Commission for the protection of women victims of violence of Morocco, as well as a GREVIO member and high-level representatives of the European Union and of the Council of Europe. The event will be followed, on 26 November, by a first (online) seminar on action against trafficking in human beings in the Southern Mediterranean region, with participation of national authorities in charge from Tunisia, Morocco, Lebanon, Jordan and Libya. Participants will discuss the experiences and the state of play of reforms in the various countries, as well as the ways of setting-up a regional anti-trafficking platform.
The Board of the project "Delivering Good Governance in Slovakia” held its second meeting on 22 October 2020, online. It brought together representatives of the Ministry of the Interior, the Ministry of Finance, the Supreme Audit Office, the European Commission's DG REFORM, local partner institutions and the Council of Europe. The members of the Board discussed progress in the implementation of the project as well as new developments and challenges, notably related to the Covid-19 pandemic.
The Centre of Expertise for Good Governance cooperates with UNDP-Tunisia and the National Association of Municipalities of Tunisia (FNVT) in order to help build capacities of the Association to provide better advocacy and services for its members. Several workshops will be organised in order to prepare the implementation of the toolkit on Modern Local Government Associations, which includes development of specific financial, communication, and advocacy strategies. The first workshop for the FNVT Leadership took place on 3 November.
ELECTIONS AND CIVIL SOCIETY
New Toolkit on “Participation of young women and girls from disadvantages groups in political and public decision-making processes at local level”The publication offers a curriculum that can be used as a model but should be tailored to the needs of the selected target group. It offers practical tools, exercises, training methods and good practices from Ukraine and other countries on greater engagement of women and girls in public and political processes at local level.
Toolkit for strengthening electoral jurisprudence is available in Georgian language and publishedThe toolkit on “Electoral dispute resolution: strengthening electoral jurisprudence” developed in cooperation with the Venice Commission and the Central Election Commission of Georgia is now available in Georgian language both electronically and in print. The document is based on the rule of law perspective focusing on ECtHR case law the good practices and experience of Georgia and Bosnia and Herzegovina. It offers a variety of training materials to be used by the professionals.
Nothing about the community without the community: urban public spaces planned based on an innovative civic engagement mechanism in Ukraine City public spaces (parks, streets, squares) in Kyiv will be designed based on citizens’ preferences as a result of the Council of Europe project “Promoting civil participation in democratic decision-making in Ukraine”. 115 citizens, representing different social groups and stakeholders contributed to public consultations around the reconstruction of the Tverskyi blind Alley in Kyiv. The new mechanism for citizen engagement in the process of urban public spaces planning has been already implemented in Drohobych and Ternopil cities, as well as in Tbilisi, where a pilot project is based on the implementation of this mechanism.
DIRECTORATE OF ANTI DISCRIMINATION
On 5 November 2020, the Children's Rights Division took part in an online exchange of views between the Greek authorities and the Secretariat of the Council of Europe on the reception and protection of unaccompanied children in the context of the execution by Greece of the M.S.S. and Rahimi judgments of the ECHR.
A Webinar on 'Educational measures to prevent risks associated with child self-generated sexual images/videos' was held on 12 November in the framework of the European Day on the Protection of Children against Sexual Exploitation and Sexual Abuse and the Council of Europe project to End Online Child Sexual Exploitation and [email protected] ([email protected]) under the Greek Chairmanship of the Committee of Ministers. Two sessions were led by Ms Dunja Mijatović, Council of Europe Commissioner for Human Rights and Ms Christel De Craim, Chair of the Lanzarote Committee, with key experts to address the importance of sex education, including "to prevent children from falling prey to sexual offenders online”. This was addressed in the context of the work carried out by the Lanzarote Committee which collected information on challenges related to the increasing trend of child self-generated sexual images/videos.
To foster and concretely support positive digital parenting approaches, the Council of Europe has published a new guidance tool on “Parenting in the digital age” containing “positive parenting strategies for different scenarios”. The guide promotes the idea that positive parenting practices, based on open communication and trust, should be extended into the online world, and provides hands-on advice on how to react, as a parent or caregiver, to critical situations encountered by children. Likewise, parents and caregivers are called upon to closely watch their own behaviours as they share online (images for example) or regularly use digital technologies throughout the day.
The Intercultural Cities Index is an assessment tool to measure cities’ performance in the implementation of intercultural policies and strategies. On 6 November the ICC programme launched the new ICC Index Charts to allow for the graphical display of all ICC members’ index results, including the level of achievement of each city, progress over time, and comparison with other cities through filtering by size, demographic diversity, population, country and policy areas. The ICC charts are available here.
COMMITTEES, BOARDS AND WORKING GROUPS
CDADI On 15 October 2020, the working group of the CDADI in charge of preparing a guidance document of the CM on responses to the COVID-19 and other crises in the fields of non-discrimination, diversity and inclusion met for the first time and agreed on a structure for this document.
ECRI ECRI held a meeting of its Working Group on the fight against antisemitism on 26 October 2020. The Working Group notably discussed the IHRA Working Definition of Antisemitism following exchanges on the matter at ECRI’s 83rd plenary meeting.
ECRI’s Task Force on LGBTI issues held a meeting on 27 October 2020. It was the second meeting of the kind. These meetings took place with the Secretariats of the PACE Equality Committee, the CoE Congress Current Affairs Committee, the Commissioner for Human Rights Office, the CoE Department for Execution of ECHR judgments, and the secretariats of the European Social Charter and of the Steering Committee on Anti-discrimination, Diversity and Inclusion (CDADI).
On 9-16 November 2020 - The “Fight against discrimination, hate crime and hate speech in Georgia” project and partner institutions will organise the second Equality Week online in Georgia. The Equality Week aims to raise awareness about the importance of diversity and equality in Georgia as well as to provide information on redress mechanisms for the victims of discrimination. The Equality Week activities can be followed on the I Choose Equality campaign’s Facebook page: https://www.facebook.com/IChooseEquality/.
On 28 October, a roundtable in Tirana/online took stock of the follow-up by Albanian institutions in implementing the recommendations from the ECRI 2020 report. Thematic sessions focused on the development and application of the legal framework for combating racism and racial discrimination as well as on the solutions for the housing problems of Roma and Egyptian minorities.
On 4 November 2020, the high-level conference "I want to go to school! On the need for inclusive and quality education" took place in Bucharest, Romania, with the participation of the Council of Europe’s Director General for Democracy, Snežana Samardžić‑Marković. The conference focused on inclusive quality education and gathered representatives of major political parties. By the end of the event, all parties had signed declarations of commitment to the inclusive education agenda. The Joint EU/CoE Project “Inclusive Schools: Making a Difference for Roma Children (INSCHOOL)” co-organised the conference. This event was streamed online by one of the main media broadcasters in the country. The link to the video message of the Director General for Democracy can be found here
On 5 November 2020, on the occasion of the World Day of Romani Language, the European Roma Institute for Arts and Culture (ERIAC) in partnership with the Council of Europe and the University of Graz, Austria, organised the International Conference Safeguarding our Romani Language. The event aimed to promote the European Curriculum Framework for Romani, to develop teaching materials based on that Framework, to support initiatives aiming at Romani language re-learning, and to organise trainings for Romani language teachers.The conference was opened by Timea Junghaus, Executive Director of ERIAC, Jeroen Schokkenbroek, Director of Anti-Discrimination of the Council of Europe, and Dieter Halwachs from Graz University.
The SOGI Unit participated in the Congress of Local and Regional Authorities of the Council of Europe’s fact-finding mission on 2 and 3 November 2020 on the situation of LGBTI persons in Poland. This mission followed a request from members of the Polish parliament regarding the increasing attacks and discrimination against LGBTI persons. The Unit supported the whole process, including offering contacts with stakeholders with whom SOGI has ongoing cooperation.
On 6 November, results and key recommendations of the public consultation process of the draft law on Barnahus in Slovenia were discussed in an online event organised by the joint EU DG Reform-Council of Europe project on supporting the implementation of Barnahus (Children House) in Slovenia. The draft law presents a major step towards the establishment of a first Barnahus in Slovenia by 2021. At international level, it is the first attempt to comprehensively regulate the establishment and operations of Barnahus in a single legally binding act. The seminar was be opened by Mag. Lilijana Kozlovič, Minister of Justice of Slovenia and involved Slovenian authorities and professionals
EDQM - THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE
Supporting vaccine developers
A broad range of technologies are being evaluated in the development of COVID-19 vaccines, from conventional approaches, such as live attenuated and inactivated vaccines, to more recent technologies, such as nucleic acid vaccines and recombinant viral vectored vaccines. Currently, limited guidance is available covering the quality of such new technologies. The EDQM has drafted a text on the control of viral vectored vaccines in order to support COVID-19 vaccine developers currently working on candidate vaccines based on this technology. This work was accomplished in collaboration with the European Pharmacopoeia (Ph. Eur.) Group of Experts on vaccines for human use (Group 15), which is composed of experts from licensing authorities, national control laboratories, academia and industry from Europe and beyond (including the United States Food and Drug Administration, Health Canada and the Therapeutic Goods Administration, Australia). This new text provides a series of analytical strategy options for the control of recombinant viral vectored vaccines. It includes recommendations on tests that may be conducted at different manufacturing stages of viral vectored vaccines and can be used by COVID-19 vaccine developers as an aid in building appropriate analytical strategies during the development of their candidate vaccines. The principles described in this document can also be used for other recombinant viral vectored vaccines. This document, entitled “Recombinant viral vectored vaccines for human use”, is not binding and will be updated to adapt to the evolving situation and to take into account experiences with new constructs or products. It has been published on the EDQM’s website on 3 November and shared with international stakeholders, including the World Health Organization’s Expert Committee on Biological Standardisation, CEPI, the Coalition for epidemic preparedness innovations, and the Biologicals Working Party of the European Medicines Agency.
Following the monthly meetings with European industry associations the EDQM has been organising since the beginning of the first confinement to keep the finger on the pulse of developments, it has now been agreed to hold monthly meetings on topics related to COVID-19 vaccines and quarterly ones on all other EDQM activities relevant for industry. The continued dialogue and the information shared by the EDQM are very much appreciated.
Continued demand for the EDQM’s reference standards
A review of the 2020 distribution figures until the end of October unsurprisingly showed a continued and increased demand for the reference standards established by the EDQM – quality medicines are more important than ever in the pandemic situation! However, while we see an increase in the number of vials distributed, the number of orders dropped compared to October 2019 as users seem to group their orders to take account of issues related to shipment and increasing prices for shipment. The most important clients are currently located in Germany, where a number of major resellers are based, followed by China and India.
GMP inspections in a lock-down situation
More than 80% of the active pharmaceutical ingredients (APIs) used in medicines for the European market are produced outside Europe, mainly in China and India. The EDQM’s Certification of suitability procedure offers a centralised assessment of the quality of APIs and is accepted in all member States of the European Pharmacopoeia Convention and many other countries around the world. In addition to the documentation-based assessment, the procedure foresees risk-based inspections of compliance with the documentation filed in the dossier and Good Manufacturing Practices (GMP) on site. The EDQM normally covers around 40 sites by on-site inspections every year. Since 2010, a complementary system of paper-based (“desk-top”) GMP assessment is carried out, either based on inspections performed by trusted authorities or by evaluating core GMP documents submitted by companies that had already been inspected by the EDQM. However, due to worldwide lock-down situations and travel restrictions, the EDQM has not been able to perform on-site inspections since the beginning of the first lock-down in March, as is the case for other international inspectorates. In order to fill the gap and to further increase surveillance in the pandemic situation, the EDQM has now conducted a first real-time remote inspection of an API manufacturer as part of a pilot project (RTEMIS) to investigate the feasibility and added value of this approach. The scope of such inspections could be to counteract travel restrictions, as is currently the case, to cover sites which have demonstrated a good level of GMP compliance during previous EDQM inspections, to verify the implementation of specific parts of a corrective and preventive action (CAPA) plan issue following an inspection, or in case of an urgent need to evaluate the GMP status, for example the evaluation of a specific aspect. The outcome of the first RTEMIS inspection carried out of an API manufacturer in India in the first week of November provided promising results and showed that this approach could be a third pillar for the supervision of GMP compliance of pharmaceutical manufacturers.
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