To mark the 16 Days of Activism against Gender-based Violence the Council of Europe is offering through a new webpage information on action taken by the organisation to prevent and combat violence against women.
On the occasion of the International Day for the Elimination of Violence against Women ( 25 November) the Secretary General of the Council of Europe issued a statement stressing the need to learn lessons from the first lockdowns this past spring, to face increasing calls to domestic violencehotlines since new restrictions have been put into place in much of Europe. She also addressed increasing online forms of sexual harassment, such as stalking and sexting, as more people stay online at home.
The Director of Human Dignity, Equality and Good governance also issued a video-message to mark the International Day.
GREVIO, adding its voice to that of the other monitoring mechanisms of the EDVAW Platform, endorsed the statement made by Dubravka Šimonović, UN special rapporteur on violence against women, its causes and consequences.
Successful Launch of the 9th Edition of the World Forum for Democracy "Can Democracy Save the Environment?"
WORLD FORUM FOR DEMOCRACY
The ambitious programme of the 9th Edition of the WFD was officially launched on 18 November through messages addressed by the main partners and an opening expert Round Table discussing the principal issues of this Forum. The next 12 months will be taken up with exploring the many questions raised by this theme in more depth and breadth. The special page for the 12 Months, 1 Question campaign will be frequently updated with new and exciting elements, from upcoming online events to videos and interviews, from Council of Europe and our partners' news to monthly illustrations from Cartooning for Peace.
European Day on the Protection of Children against Sexual Exploitation and Sexual Abuse
On 18 November, the European Day on the Protection of Children against Sexual Exploitation and Sexual Abuse was the occasion to promote a large variety of awareness raising tools (videos, communication material, information websites, brochures, …) prepared by our partners in various languages, and to launch the new guidance tool on "Parenting in the digital age" and the new awareness-raising tool “Kiko and the Manymes”. The webpage dedicated to this year’s edition on “Preventing risky behaviour by children: child self-generated sexual images and/or videos” display information and links to the many activities carried out by partners on this occasion. Of particular importance are the Joint statement made by the outgoing and the incoming CM Chairs, the Secretary General and PACE President, the Joint statement issued by six Council of Europe member States and supported by the 41 other, the Declaration by the Chairperson of the Lanzarote Committee and that by the Chairperson of the Steering Committee for the Rights of the Child (CDENF).
11th European Platform for Youth Centres in the Quality Label network
The European Platform dedicated this year’s annual meeting to discussing the impacts of the pandemic on quality-labelled youth centres. More than 60 participants from 20 youth centres met online on 19 and 20 November to share initiatives and innovative approaches to the challenges they have been facing this year, to exchange good practices on shaping new youth work spaces and developing digital youth work, and to identify support and partnership. The Council of Europe Quality Label for youth centres programme was launched more than a decade ago, with the main aim to enhance quality in youth work and networking among youth centres across Europe which aspire to the values of the Council of Europe.
9th CDCPP Plenary Session The 9th CDCPP session (10, 12 & 13 November) featured three thematic debates: Covid-19 and culture; AI, culture, creativity and cultural heritage; Sustainable Development and climate change. This generated insight and action proposals for future Committee work. The CDCPP launched the Manifesto, Freedom of Expression of Arts and Culture in the Digital Era, and plans for a new digital CoE arts exhibition, “Free to Create - Create to be Free”, as a contribution to the 70th anniversary of the European Convention on Human Rights. Future CDCPP work will include preparation of new CM Recommendations on topical issues, AI, culture and creativity.
Qualitications Passport for refugees
The European Qualifications Passport for Refugees was presented at a Forum of experts on migration and refugee policy as a practical way of applying non-discrimination principles and equal treatment so that refugees can continue their studies or find a job relevant in their field. The EQPR was also identified as a way to support the implementation of the UN Global Compact on Refugees.
Online living library in schools
First online living library in schools in HungaryA pilot project on the online version of the Living Library in Schools programme was launched on 12 November. The very first online Living Library in Schools in Hungary was organised with the participation of two classes of the Lauder Javne High School in Budapest. Two teams of nine living books and 50 students took part in this new format of the long-running project.
Meeting of the Italian Faro Convention Network
The second meeting of the Italian Faro Convention Network took place online (11 November) to discuss the Covid-19 impact on initiatives, and their enhancement, given the recent ratification of the Faro Convention by the Italian Parliament. The participants agreed to reinforce exchanges between the increasing initiatives, through improved technological tools, and launched the intention to organise an online celebration of the recent Faro Convention ratification (12 December), through diverse contributions from initiatives, illustrating current work;
Workshop for ECML National Authorities
A workshop for ECML National Authorities took place on 17 November. In addition to providing participants from 28 of the 33 member states with an insight into new programme activities, the event focused on the promotion, implementation and evaluation of the 2016-2019 Programme, Languages at the heart of learning. Following a request from the European Commission for innovative methodologies and assessment in language learning for 2021, the ECML submitted an application for the action with a total budget of € 656.000. The action will complement the standard capacity building in the areas of Supporting Multilingual Classrooms and RELANG
Democratic Citizenship Education
EDUCATION - ALBANIA
Under the SIDA-funded project Strengthening Democratic Citizenship Education in Albania, a conference on “Democratic Citizenship Education” took place on 19 November. Over 100 representatives from the Parliament, the Ministry of Education, Youth and Sports, education institutions and CSOs debated the future of citizenship and human rights education. Participants recognised the need to make use of lessons learnt from the pandemic to improve education institutions’ functioning. The conference also served to launch the network of 25 democratic and inclusive schools which will act as a community of practice and peer exchange
A framework for establishing a European Youth Work Agenda
Under the German EU Presidency, on 20 November, member states approved Council Resolution 13185/20 on the Framework for establishing a European Youth Work Agenda. The document sets the framework for the development of a future European Youth Work Agenda, highlighting the added value and importance of enhancing co-operation with the Council of Europe in this youth sector priority for both the EU Youth Strategy 2019-2027 and the Council of Europe youth sector strategy 2030. In addition to referencing the key role the Council of Europe plays in youth work development in Europe
The Secretariat is actively preparing the 161st plenary meeting of the Board of Management, which will be held once again online on 10 and 11 December with interpretation via the KUDO software and digital voting.
Co-production projects submitted on 20 October for the last call of the year will be examined by online working groups composed of national delegations from 7 to 9 December.
In parallel the implementation of the first set of changes to the Fund’s operation, as approved by its Board of Management in October 2019, is being prepared and the revised working methods communicated to potential beneficiaries. The implementation of the second set of changes, to the governance of the Fund and the methods of selection of projects, will be prepared during 2021.
The Fund’s Gender Equality Working Group is currently discussing its action plan for the period 2021 to 2023 with a view to Board adoption in December and the launch of activities in early 2021.
The 21st edition of the “Etoiles et Toiles du Cinéma Européen” event, which showcases international co-productions supported by Eurimages, concluded on 17 November 2020. In an exceptional context of lockdown, the closing ceremony was recorded in the presence of the President of Eurimages, the President of the Jury (Michele Giacomelli, Ambassador of Italy) and the rest of the jury, composed principally of Ambassadors to the Council of Europe and the Deputy Secretary General of the Council of Europe. Two prizes and a special mention were awarded, the Odyssée – Council of Europe prize for Artistic Creation to the film “Arrhythmia”, a Russian, Finnish and German co-production directed by Boris Khlebnikov, the Odyssée – Council of Europe Prize for Human Rights to Radu Jude’s “I Don’t Care if We Go Down in History as Barbarians”, a co-production led by Romania, and the special mention went to the French-led co-production “It Must Be Heaven”, directed by Elia Suleiman.
The second #Solidaction webinar took place on 19 November. João Mareco, Lawyer specialised in media literacy (Portugal), Latifa Akharbach, President of the High Authority of audiovisual communication (Morocco) and Mbuki Mburu, Civic engagement officer at Pawa254 (Kenya), took part in an interactive discussion moderated by Ms Cathie Burton to respond the question: INTERNATIONAL SOLIDARITY: Which paths to guarantee long lasting changes?Central to the #SolidAction campaign is the understanding that one powerful way to ensure international solidarity is to develop resilient and critical societies of self-motivated and well-informed citizens. This is why this second series’ webinar merged with another flagship initiative of the North-South Centre: the Global Education Week.
The North-South Centre is joining the campaign “16 days of Activism Against Gender-based Violence”, and developing a campaign that raises awareness on the (de)normalisation of violence against women and girls “It is not normal”. It consists on the publication of several different cartoons/comic strips representing various forms of violence that very often are not even identified as violence, leaving no place for combating it. The cartoons are made by women artists from Zimbabwe, Sudan, Spain, Colombia and Algeria, young and more experienced, who work upon different topics such as son preference, sexual harassment or forced marriage, always on the ground of intersectionality.
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. The 2019 Prize Laureates are Ms Nabila Hamza and Mr Leoluca Orlando and will be delivered by the Portuguese President Marcelo Rebelo de Sousa. The Secretary General of the Council of Europe, the President of the Parliamentary Assembly of the Council of Europe, the President of the Portuguese Assembly of the Republic and the President of the Executive Committee of the North-South Centre will also participate in this hybrid event, which will take place during the 2020 Lisbon Forum. This year’s Forum will be devoted to “Learning from our global challenges: Enhancing Solidarity”. In line with the #Solidaction Campaign, and on the 70th anniversary of the European Convention of Human Rights, the Lisbon Forum 2020places life, people, and the planet at the core of a debate under the theme : Learning from our global challenges: Enhancing Solidarity.
The North-South Centre organised a session in partnership with the Union for the Mediterranean during their Regional Forum on “Civil society & gender equality” on 16 November.
DIRECTORATE OF HUMAN DIGNITY, EQUALITY AND GOVERNANCE
Women in Local Government in Greece: Equal Participation for Stronger Democracy
Why so few women participate in political life at local level in Greece? To answer this question, the Greek Ministry of Interior asked the Centre of Expertise for Good Governance to conduct a Study on Participation of Women in Political Life at Local Level in Greece”. The results of this study, conducted under the project "Delivering Good Governance in Greece", were presented on 9 November under the auspices of the Greek Chairmanship of the Committee of Ministers of the Council of Europe, during the online event on “Women in Local Governments: Equal Participation for Stronger Democracy”.As underlined by Snežana Samardžic-Markovic, Director General of DG Democracy of the Council of Europe, “A more diverse representation in positions of responsibility increases the legitimacy and efficiency of policy-making processes and, in general, leads to better, more democratic and representative governance”. Other speakers at the event included Miltiadis Varvitsiotis, Alternate Minister of Foreign Affairs, Panagiotis Theodorikakos, Minister of Interior, and Anne Brasseur, former President of the Parliamentary Assembly of the Council of Europe. A recording of the event is available on YouTube.
COMMITTEES, MONITORING, WORKING GROUPS,
GRETA held its 39th meeting on 18-20 November. It adopted final reports on Bulgaria, Denmark and Georgia as part of the third evaluation round of the Convention. Further, GRETA adopted a guidance note on preventing and combating trafficking in human beings for the purpose of labour exploitation, which will be transmitted for consideration to the Committee of the Parties and published, as part of the Secretary General Roadmap on strengthening action against trafficking in human beings for the purpose of labour exploitation. In light of the sanitary and travel restrictions related to COVID-19, GRETA also updated its timetable of evaluation visits.
The Committee of the Parties to the Convention will hold its 27th meeting on 4 December. In addition to the consideration of the work carried out by GRETA in the implementation of the Secretary General Roadmap, the CoP will inter alia discuss draft recommendations concerning Albania, Croatia and the Republic of Moldova, for adoption, and a draft resolution on financial arrangements for the participation of non-member States in the Convention. It will also elect eight GRETA members.
Publication of three new GREVIO reports GREVIO published the first baseline evaluation reports on MaltaSpain and Andorra. The reports contain a comprehensive analysis of the implementation of the provisions of the Istanbul Convention by the countries concerned, welcoming the action carried out so far, highlighting relevant good practices, and drawing attention on the issues where improvements are warranted to reach higher levels of compliance with the requirements of the convention.
CEB marks a record volume of project approvals At its recent meeting, the Bank’s Administrative Council approved four new loans for social infrastructure projects in Germany, Lithuania, and Serbia. Cumulatively, the CEB’s 2020 approvals thus slightly exceed €6 billion, which represents an increase by €2 billion compared to those recorded in 2019.
Several services of the Council of Europe joined forces to organise an internal virtual photo exhibition “Orange the World! Orange your Home!”, which will be launched on 25 November and run throughout the 16 Days of Activism. Staff members and members of Permanent Representations are invited to send their pictures to [email protected] until 10 December
A social media campaign focusing on disseminating infographics and brochures on the 4 pillars of the Istanbul Convention will be launched in Azerbaijan.
The project in Kosovo* will feature an online campaign on preventing and combating sexism, information sessions with women organisations and an online roundtable on women journalists, and a joint OSCE/Council of Europe High-Level Conference “Applying the Istanbul Convention: What does it mean in practice?”.
In Turkey, an international webinar is organised on 30th November 2020 on administrative data collection and analysis on violence against women, in co-operation with the Ministry of Family, Labour and Social Services, the Ministry of Interior and the Ministry of Justice. The webinar aims at increasing understanding of relevant international standards on data collection and analysis on violence against women, at sharing experiences and lessons learnt and at encouraging co-ordinated data collection and dissemination among relevant public authorities.
In Tunisia, the launch of a Booklet of rights of women victims of violence and of the HELP course on violence against women will take place respectively on 8 and 9 December. Awareness raising materials aiming at providing more visibility to the law on the elimination of violence against women will support these initiatives.
Two awareness-raising spots will be broadcasted in Morocco, one on the law related to the fight against violence against women and another on the National commission for the protection of women victims, accompanied by leaflets in Arabic and French. The premises of the Council of Europe in Rabat will be illuminated in orange during this period of mobilisation to maximise the visibility of these topics among the general public.
Training of labour inspectors and education professionals on human trafficking under the Horizontal Facility programme in 3 countries A workshop on human trafficking for labour exploitation was organised in Serbia for 15 labour inspectors from 8 cities, focusing on their role in preventing, detecting and referring potential victims of human trafficking for labour exploitation. The National Anti-trafficking Co-ordinator, representatives of the Centre for Human Trafficking Victims’ Protection and civil society organisations took part in it. Similar workshops will be organised in Bosnia and Herzegovina in December. 3-day training sessions on trafficking in children, targeting education advisors and professionals have been organised in Serbia and in North Macedonia. The trainings highlight of the role of school administrations and their employees in preventing and detecting child trafficking, and include the presentation of indicators for the detection of potential child victims of trafficking.
Two new infographics have been published in Ukraine explaining respectively myths and facts about the Istanbul Convention and the needed changes to the Ukrainian system of assistance for victims of violence against women and domestic violence if the Istanbul Convention is ratified. The infographics are accompanied by explanatory brochures and a video based on these materials is forthcoming.
Developing a National Action plan for combating Domestic Violence in Armenia
Building resilience to tackle emergencies: ReBus, the new toolkit for local authorities
The COVID-19 pandemic has left Council of Europe member States facing an emergency unprecedented in both scale and scope.
A major lesson learnt from this experience is that public authorities should be better equipped to prevent, identify and manage emergencies, of any kind. The Centre of Expertise for Good Governance has developed ReBus, a new toolkit aimed at helping local authorities enhance institutional and community resilience, robustness and a strategic approach to reduce risk, manage emergencies and focus on recovery. ReBus is at the disposal of all member States who would like to test it.
New Council of Europe toolkit for civil society organisations "Monitoring of media coverage of elections" now available
The toolkit provides civil society organisations with detailed methodology, practical guidelines and useful tips on how to give professional, comprehensive and objective assessment of political diversity and balance in the news and current affairs coverage during elections.
Republic of Moldova: Role and status of the permanent electoral body in ATU Gagauzia discussed
To make clear the role and the status of the Central Electoral Commission of the Autonomous Territorial Unit of Gagauzia (CEC Gagauzia) in the electoral management system of the Republic of Moldova is an aim of the Working group set up in July 2020.The Working Group consists of the representatives of the Central Electoral Commission of the Republic of Moldova (CEC), CEC Gagauzia, the People’s Assembly and the Executive Committee of ATU Gagauzia. The Council of Europe experts supporting the Working Group came up with several alternative proposals as to change the national election-related legislation and brought out the associated advantages and disadvantages
Ukraine:Participatory budgets for school meet with substantial interest
95 % of school students of grades 7-11 in Ternopil and 98 % of grades 5-11 in Krolevets have recently voted for School participatory budgeting projects, piloted thanks to the support of the project “Promoting civil participation in democratic decision-making in Ukraine”. Currently the project is implementing the Council of Europe toolkit on School participatory budgeting in a range of Ukrainian municipalities. 235 school students and 100 local officials and teachers gained skills and knowledge in the application of this tool as a result of the online capacity building initiatives implementation – a series of online webinars, online practical courses and coaching. As a result, 7800 school students in Ternopil and Krolevets developed their ideas into projects that will enhance school infrastructure, the quality of the educational process and leisure of schoolchildren.
DIRECTORATE OF ANTI DISCRIMINATION
EVENTS on the occasion of the European Day on the Protection of Children against Sexual Exploitation and Sexual Abuse
Amongst the activities organised on 18 November was a flash-mob with participation of 50 children Chisinau organised within the framework of the Council of Europe project Combating violence against children in the Republic of Moldova and launching a wide-ranging awareness raising campaign to last until the end of 2021. The project also organised an online event on 23 November 2020 to launch the Kiko and the Hand Training for Trainers manual for kindergarten teachers in the Republic of Moldova. The manual has been endorsed by the Ministry of Education, Culture and Research of the Republic of Moldova and is a milestone in developing methodological guidelines for training kindergarten teachers on detecting and reporting sexual abuse cases. Training sessions based on the manual are foreseen in 2021.
On 20 November on the occasion of the World’s Children’s Day, the Council of Europe and the European Asylum Support Office (EASO), launched jointly an animation that explains to children undergoing age assessment procedures in the context of migration the processes and professionals involved, and what it entails for the process to be conducted in a manner that respects their human rights and dignity. The animation is released in English,French, Spanish and Portuguese, and the Council of Europe will soon release it also in Arabic, Pashto, Dari, Tigrinya, Somali and Punjabi. This tool is primarily aimed at children and should also be used by professionals working with children, especially guardians.
Also to mark World Children’s Day (20 November), the Government of Andorra launched an ambitious child consultation process in support of the drafting of its National Plan for Children and Adolescents. The government plans to consult and involve the entire child population of Andorra, approximately 11,000 children, in this process. At the request of the government, the Council of Europe provides technical support for this National Plan process, including through carrying out mapping, review of the regulatory framework, provision of guidance and recommendations for stakeholder consultations and drafting of the Action Plan.
Intercultural Cities publishes: “Creative bureaucracy: from a "No, because..." to a “Yes, if” culture” briefing paper
How do we create a civic city in a digital, globalised society fragilised by the sanitary and economic crisis? How to make the shift from a vision of the city as “mine” to “our” city? Where do we belong when people are constantly moving around, and the city is itself in motion and transformation?The creative bureaucracy notion is fundamental for the intercultural city which needs to create the conditions for people and their systems to be able to think, plan and act with imagination to solve problems and create opportunities by harnessing the talents of their diverse citizens.
On 12 November, the CDADI Working Group on COVID-19 responses held its second meeting and worked on the draft for a CM guidance document on the promotion of equality and the protection from discrimination and hate during the COVID-19 and similar crises.
On 16-18 November, the Steering Committee for the Rights of the Child (CDENF) held its second plenary meeting online. The governments and observer organisations represented on the Committee had fruitful discussions on a number of issues, including an upcoming draft Declaration by the Committee of Ministers on the need to intensify efforts to respect and protect children’s privacy in the digital environment. Exchanges were held with several high-level officials and experts: Mr Adrien Taquet, Secretary of State on children and families at the French Ministry of Solidarity and Health, and Ms Najat Maalla M’jid, Special Representative of the UN Secretary General on Violence against Children respectively addressed the Committee on the preparation of the draft Council of Europe Strategy for the Rights of the Child (2022-2027) and topical challenges of violence against children.
On 16 November, the representatives of the Parties to the Lanzarote Convention held an informal exchange to share information on their legal frameworks with reference to the automatic detection and reporting of online child abuse material. Parties appreciated the possibility of openly discussing the potential impact of imminent decisions to be taken in the EU framework in this regard and asked the Secretariat to organise another exchange with legal and technical specialists to go deeper in the complex issues at stake. This further exchange will be held on 1 December. It will be open to the Committee’s observers and participants (not only to the representatives of Parties).
On 23 November, the Lanzarote Committee held its 29th plenary meeting which was entirely dedicated to the examination of the legal chapters of its forthcoming 2nd monitoring round report. It is recalled that this monitoring round is meant to shed light on how Parties may best address the challenges raised by child self-generated sexual images and/or videos. As such challenges are numerous and the related legal issues are very complex, the Committee will have to pursue their examination in a forthcoming meeting.
Following the launch conference of 4 November 2020, with the participation of Snežana MARKOVIC-SAMARDZIC, Director General of Democracy of the Council of Europe, a series of debates among main political parties continued on 11 November with a session on early education and on 18 November 2020 with a session on vocational education and training. The events, supported by UNICEF, were organised under the auspices of the “Educated Romania” project and co-organised by the Foundation “Impreuna”, the University of Bucharest, the European Commission Representation in Romania and the EU/CoE Joint Project “INSCHOOL”.
On 17 November, the Department for National Minorities of Lithuania organised a follow-up meeting to discuss the implementation of the FCNM Advisory Committee’s 4th cycle recommendations with a broad range of stakeholders. More than 35 representatives of national and local authorities, national minorities, civil society and academia attended the meeting virtually. The discussion focused on the development of a legal framework on national minorities and on several issues concerning the Roma minority in Lithuania. The Lithuanian authorities were congratulated by the experts representing the Advisory Committee on the progress made in the past years and on the development of a new draft law on national minorities in close consultation with minority representatives
On 21 November an online training course was organised for 20 volunteers to conduct a survey about hate speech across Morocco. The training on the interview guide and questionnaires was followed by a practical workshop on hate speech and Council of Europe standards. The survey is part of the research for a study on hate speech in Morocco which is being carried out under the “Combating discrimination in Morocco” project.
A Webinar on “Intersex persons and the challenges they face in Serbia” was held on 20 November 2020. The event - organised by the Council of Europe SOGI Unit in partnership with the No hate speech and cooperation unit and XY Spectrum Serbia, - provided an overview of relevant legal and policy frameworks, and addressed the current social and legal situation of intersex persons in Serbia. The public webinar was followed by dozens of participants around Europe
EPAS - Enlarged Partial Agreement on Sport
The International Partnership Against Corruption in Sport (IPACS) held its Steering Committee meeting via virtual means on 16 November 2020. More than 200 participants from 50 governments (including most EPAS member states), 14 intergovernmental organisations and 25 sports organisations attended, clearly confirming their commitment towards international co-operation for values-based sport, the eradication of corruption in sport and their readiness to work together in IPACS. The opening up of the Steering Committee to any state interested in participating, and the creation of its Bureau are welcome steps and respond to a wish expressed by European governmental experts. As co-ordinator of Task Force 3, EPAS particularly welcomes the work done so far on creating a sports governance benchmark, a particular step towards a better governance in sport which will inspire the building of trust-based partnerships between public authorities and the sports organisations.
The EPAS Consultative Committee organised a virtual workshop on 19 November called “Raising Awareness of Human Rights in Youth Sports: the Role of Sport Organisations and Educational Institutions”. The workshop was led by Mr Kole GJELOSHAJ (Chair of the Consultative Committee and Deputy Secretary General of the International School Sports Federation) and was moderated by Mr Louis MOUSTAKAS (Secretary General of the European Network of Sport Education). An array of speakers addressed issues such as “which human rights are currently challenged in youth sport?” and “how can we educate practitioners to support human rights in sport?”; this was followed by a 30-minute Q&A session with the public.
Europe at the World Anti-Doping Agency’s Foundation Board and Executive Committee Meetings
The first weeks of November were marked by intensive consultations between the Heads of Delegations of the Council of Europe Ad Hoc European Committee for the World Anti-Doping Agency (CAHAMA) regarding the European position on different substantial matters on the agenda of the World Anti-Doping Agency’s (WADA) statutory meetings. Positions approved following the 51st and 52nd (extraordinary) CAHAMA meetings were implemented by the European representatives appointed to the WADA Executive Committee and Foundation Board https://www.wada-ama.org/en/foundation-board. Among the most important decisions were the review of the WADA reform, 2021 Budget, membership of the statutory bodies and advisory committees, Covid-19 impact on anti-doping programs worldwide. As a result majority of positions expressed and agreed by the CAHAMA were adopted by the WADA Executive Committee and Foundation Board; the summary of decisions is available: https://www.wada-ama.org/en/media/news/2020-11/wada-executive-committee-and-foundation-board-expand-upon-agencys-governance
Webinar on the impact of COVID-19 on safety, security and service at sports events (S4)
The secretariat of the Spectator Violence and Saint-Denis Conventions of the Council of Europe held a restricted webinar last 19 November with the aim, on one hand, to discuss the findings of the survey on the impact of COVID-19 on safety, security and service at sports events (S4) and, on the other land, to exchange on the latest developments and measures envisaged to tackle the current second wave of the pandemic. This webinar, which was attended by around 70 experts from States and sports and supporters organisations, covered the following issues: findings of the survey on the Impact of COVID-19 on S4 policies and practices; experiences and challenges of national football championships; impact on UEFA and FIFA competitions; impact on international police cooperation; relations with supporters across Europe; and also, of course, the challenges ahead for the safe and secure return of spectators to sports grounds. Conclusions and recommendations taken from this webinar should be published soon.
EDQM - THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE
New pharmacopoeial texts adopted to protect patients’ health
During its November session, the European Pharmacopoeia (Ph. Eur.) Commission adopted more than 100 new and revised texts, including new general chapters on the control of N-nitrosamines in active pharmaceutical ingredients (APIs) and on contaminant pyrrolizidine alkaloids (PAs) in herbal products. N-nitrosamines are classified as probable human carcinogens based on animal tests. While they occur at low levels in certain foods, e.g. smoked/cured meat and fish, their presence in medicines has to be avoided and if this is not possible, tightly controlled and limited – only very low amounts are acceptable according to current regulatory requirements. Their detection requires highly sensitive analytical methods. Following the identification of N-nitrosamines in certain antihypertensive medicines containing APIs of the sartan class in 2018 and later on in other APIs and medicines, the EDQM and the Ph. Eur. Commission immediately took a number of measures, in close co-operation with European and international regulators, including the development of analytical methods for their control. The newly adopted general chapter was initially elaborated with the objective of developing validated limit tests for N-nitrosamine impurities in sartan active substances with a tetrazole ring. It provides a toolbox of analytical procedures using different instruments as it was considered important to cover the diverse needs of many quality control laboratories in Europe and worldwide. To further support users in the application of these tests, seven reference standards have been established by the EDQM. When adopting the chapter on Nov. 24, the Ph. Eur. Commission decided to go for an immediate revision to further enhance the text with a framework for the testing of medicinal products. This decision was taken as it has been demonstrated, in the meantime, that other factors than the API can lead to the appearance of N-nitrosamines in medicines, e.g. interactions between the API and excipients used in the formulation, or interactions with the medicine’s primary packaging material, e.g. lidding foils used in the production of blisters. In view of the global use of medicines that have been found to contain nitrosamine impurities, the Ph. Eur. also works with the United States Pharmacopoeia towards convergence to ensure that the public quality standards of the two pharmacopoeias are consistent. While the chapter will be included in Ph. Eur. Supplement 10.6, to be published in July 2021, the EDQM has decided to immediately make the text available to users on its website filling a gap in the public availability of robust and validated analytical procedures for the control of N-nitrosamines.Pyrrolizidine alkaloids (PAs) are nitrogen-containing compounds that occur naturally in plants - several hundred structurally distinct PAs have been found in several thousand different plant species. Many of these plants are common weeds, which can contaminate raw plant materials used for the production of herbal medicinal products. This results in contamination of raw plant materials by PAs, usually at very low levels. PAs have been known for many years for their acute toxic, genotoxic and carcinogenic potential The new general chapter on Contaminant pyrroliozidine alkaloids covers trace analysis of target PAs in herbal drugs, preparations thereof and medicinal products. It does not cover the determination of PAs that occur naturally in plant materials. The chapter represents an important contribution to the safety of herbal medicinal products and the protection of patients’ health.
ACTIVITIES AT AN INTERNATIONAL LEVEL
A number of EDQM scientists participated in the autumn meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), an association under Swiss law, which brings together regulatory authorities, regional harmonisation initiatives, international organisations and pharmaceutical industry from around the globe to discuss scientific and technical aspects of the marketing authorisation of medicines. The EDQM is an observer to the ICH Assembly, the ICH’s governing body, and currently participates in nine ICH Expert Working Groups (EWGs) tasked with the elaboration of new or revision of existing harmonised guidelines on the quality of medicines. Topics covered by these EWGs include the definition of requirements for the implementation of new approaches to the manufacture and control of medicines, such as continuous manufacture of APIs and medicines and quality by design principles in the development of analytical procedures. Two of the EWGs with EDQM participation serve as a “think tank” for the Assembly to reflect on future needs regarding quality guidelines and on specific needs for generics. The next meeting of the Assembly will take place in June 2021, and the different EWGs will report on the progress made and submit finalised guidelines for adoption. The EDQM also participated in the autumn meeting of the International Pharmaceutical Regulators Programme (IPRP) on 19-20 November. The IPRP currently has 30 regulatory members – 24 regulatory authorities and 6 regional harmonisation initiatives from all continents – and the EDQM and the WHO as observers. It provides a forum to exchange information on issues of mutual interest and to enable regulatory co-operation. It assists in maximising potential efficiencies in addressing the increasingly complex global regulatory environment, facilitates the implementation of ICH and other internationally harmonised technical guidelines for medicines for human use, promotes collaboration and regulatory convergence, and contributes to the coordination of a range of international efforts related to regulation of medicinal products for human use. In its update on significant regulatory developments, the EDQM reported on its support to COVID-19 vaccine developers and the publication of the text on recombinant viral-vectored vaccines and the product specific OCABR guidelines. The IPRP also received reports from its nine working groups and adopted their respective work programs for 2021. The IPRP Quality Working Group is co-chaired by the EDQM. Both ICH and IPRP meetings were initially planned to take place in Athens, but had to be converted into virtual meetings due to the sanitary crisis.
* « This designation is without prejudice to positions on status and is in line with UNSCR 1244 and the ICJ Opinion on the Kosovo Declaration of Independence. »
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