Executive director is commonly the title of the chief executive officer (CEO) of a non-profit organization , government agency or international organization .
38-470: The Common Technical Document ( CTD ) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by
76-564: A centralised (or "community") marketing authorisation (MA) valid in all European Union member states and in Iceland , Liechtenstein and Norway . The centralised procedure is compulsory for all medicines derived from biotechnology and other high-tech processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for veterinary medicines for use for growth or yield enhancers. It
114-405: A high-level strategic plan, but it is the role of the executive director to create implementation plans that support the strategic plan. The executive director is a leadership role for an organization and often fulfills a motivational role in addition to office-based work. Executive directors motivate and mentor members, volunteers, and staff, and may chair meetings. The executive director leads
152-469: A managerial position with the corporation. In this context the role is usually contrasted with a non-executive director who usually holds no executive, managerial role with the corporation. There is much national and cultural variation in the exact definition of an executive director. The title is used for the chief executive officer of several UN agencies, such as UN Women . In the US, an executive director
190-535: A number of scientific working parties. The Secretariat is organised into five units: Directorate, Human Medicines Development and Evaluation, Patient Health Protection, Veterinary Medicines and Product Data Management, Information and Communications Technology and Administration. The Management Board provides administrative oversight to the Agency: including approval of budgets and plans, and selection of executive director . The Board includes one representative of each of
228-508: A product. Executive director The title is widely used in North American and European not-for-profit organizations, though in the United States many have adopted the title ' president ' or CEO. It generally has the same meaning as CEO or managing director . The title may also be used by a member of a board of directors for a corporation , such as a company , cooperative or nongovernmental organization , who usually holds
266-441: Is a chief executive officer (CEO) or managing director of an organization , company , or corporation . The title is widely used in North American not-for-profit organizations , though many United States nonprofits have adopted the title president or CEO. Confusion can arise because the words executive and director occur both in this title and in titles of various members of some organizations' boards of directors. In
304-446: Is also compulsory for advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines and for orphan medicines (for rare diseases). The centralised procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health. As a result, the majority of genuinely novel medicines are authorised through
342-759: Is carried out through the Committee for Medicinal Products for Human Use (CHMP). If the Committee concludes that the quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the European Commission to be transformed into a marketing authorisation valid for the whole of the EU. A special type of approval is the paediatric-use marketing authorisation (PUMA), which can be granted for medical products intended exclusively for paediatric use. The CHMP
380-647: Is obliged by the regulation to reach decisions within 210 days, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data. The review process of the European Medicines Agency regarding medical issues has been criticized for its lack of transparency. In a rebuttal of an EMS review that included her work, Louise Brinth, a Danish physician, noted that "experts" reviewing data remain unnamed and seem to be bound to secrecy. Minutes are not released and diverging opinions are not reported suggesting that all
418-741: The Coalition for Epidemic Preparedness Innovations ' Joint Coordination Group. It is also a benefactor of Health Level Seven International , a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Pharmaceutical Regulators Programme (IPRP), and a partner of the Society for Immunotherapy of Cancer and Vaccine Confidence Project . A single evaluation
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#1732793754645456-602: The European Commission had to decide on the fate of the EMA's location. The EU ministers met to vote on their preferred successor. The EU's Health Commissioner Vytenis Andriukaitis said that the preferred choice would be a location where an "easy set up and guarantee of smooth operations" would be available. Member states who had expressed their bid for the new EMA location were Austria , Belgium , Bulgaria , Croatia , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hungary , Ireland , Italy , Malta ,
494-606: The European Medicines Agency (EMA, Europe), the Food and Drug Administration and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). After
532-473: The European Union and the pharmaceutical industry , as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not only reduce the €350 million annual cost drug companies incurred by having to win separate approvals from each member state but also that it would eliminate
570-675: The Netherlands , Poland , Portugal , Romania , Slovakia , Slovenia , Spain , and Sweden (or in other words all remaining member countries except for the Baltic States and Luxembourg). It had also been speculated that the Strasbourg -based seat for the European Parliament could be moved to Brussels, in exchange for the city to host the EMA. Others speculated on the merits of Amsterdam, well before
608-448: The protectionist tendencies of sovereign states unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EMA was founded after more than seven years of negotiations among EU governments and replaced the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, though both of these were reborn as the core scientific advisory committees. The agency
646-575: The "experts" are of the same opinion. In her view the process is unscientific and undemocratic. The Committee for Medicinal Products for Veterinary Use (CVMP) operates in analogy to the CHMP as described above. The Committee on Orphan Medicinal Products (COMP) administers the granting of orphan drug status since 2000. Companies intending to develop medicinal products for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than five in 10,000 persons in
684-655: The 27 Member States, two representatives of the European Commission , two representatives of the European Parliament , two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations. The Agency decentralises its scientific assessment of medicines by working through a network of about 4500 experts throughout the EU. The EMA draws on resources of over 40 National Competent Authorities (NCAs) of EU Member states. The EMA additionally engages with international agencies and non-governmental organizations on areas of mutual interest, such as its participation on
722-657: The CTD requirements. European Medicines Agency The European Medicines Agency ( EMA ) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products . Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ). The EMA was set up in 1995, with funding from
760-675: The Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, though both of these were reborn as the core scientific advisory committees. The agency was located in London prior to the United Kingdom's vote for withdrawal from the European Union , relocating to Amsterdam in March 2019. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ). The EMA contributed to
798-419: The EMA. For products eligible for or requiring centralised approval, a company submits an application for a marketing authorisation to the EMA. The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry , as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope
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#1732793754645836-748: The European Union , seeking to expedite the development and approval of COVID-19 vaccines and treatments . It participated in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public–private partnership hosted by the Foundation for the National Institutes of Health , collaborating with international government agencies and corporations to coordinate a research strategy for prioritizing and speeding up development of COVID-19 vaccines and pharmaceutical products. While in
874-506: The European Union can apply for 'orphan medicinal product designation'. The COMP evaluates the application and makes a recommendation for the designation which is then granted by the European Commission . The Committee on Herbal Medicinal Products (HMPC) assists the harmonisation of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in
912-530: The European regulatory framework since 2004. The Paediatric Committee (PDCO) deals with the implementation of the paediatric legislation in Europe Regulation (EC) No 1901/2006 since 2007. Under this legislation, all applications for marketing authorisation of new medicinal products, or variations to existing authorisations, have to either include data from paediatric studies previously agreed with
950-797: The Global Vaccine Action Plan developed by the Decade of Vaccines Collaboration, endorsed by the 194 Member States of the World Health Assembly in May 2012, and published on the World Health Organization 's website in February 2013. Following the 2016 decision of the United Kingdom to leave the European Union (" Brexit "), the EMA chose to search for another base of operations. According to EU Law
988-450: The PDCO, or obtain a PDCO waiver or a deferral of these studies. The Committee for Advanced Therapies (CAT) was established in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products (ATMPs) such as gene therapy , somatic cell therapy and tissue engineered products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in
1026-406: The US nonprofit sector, the executive director role is the highest ranking position within the organization. It corresponds to a CEO position in a for-profit corporation. The role of the executive director is to design, develop and implement strategic plans for the organization in a manner that is both cost and time-efficient. The executive director is also responsible for the day-to-day operation of
1064-591: The United States, European Union and Japan, the CTD was adopted by several other countries including Canada and Switzerland. Paper CTDs are destined for replacement by their electronic counterparts, the eCTDs . The Common Technical Document is divided into five modules: Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to
1102-621: The evaluation and monitoring of centrally authorised products and national referrals, develops technical guidance and provides scientific advice to sponsors. Its scope of operations is medicinal products for human and veterinary use including biologics and advanced therapies, and herbal medicinal products . The agency is composed of the Secretariat (ca. 600 staff), a management board, seven scientific committees (human, veterinary and herbal medicinal products, orphan drugs , paediatrics, advanced therapies and pharmacovigilance risk assessment) and
1140-577: The field. A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) has come into function in 2012 with the implementation of the new EU pharmacovigilance legislation (Directive 2010/84/EU). The Agency carries out a number of activities, including: The centralised procedure allows companies to submit a single application to the agency to obtain from the European Commission
1178-540: The final decision was made. The decision on the relocation was made on 20 November 2017, during the EU General Affairs Council meeting, after three voting rounds and finally drawing of lots. After the first round of voting, Milan (25 votes), Amsterdam (20 votes) and Copenhagen (20 votes) were the only contenders left. After the second voting round, two cities were left: Milan (twelve votes) and Amsterdam (nine votes). These two cities tied in
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1216-474: The organization and develops its organizational culture . In the UK, an executive director is a member of a board who is also an employee with a senior role. It is common for boards to have several executive directors, e.g. for different departments. There is no legal difference between an executive and a non-executive director (NXD or NED), but there are considerable differences in the expectations associated with
1254-406: The organization, which includes managing committees and staff as well as developing business plans in collaboration with the board. In essence, the board grants the executive director the authority to run the organization. The executive director is accountable to the board of directors and reports to the board on a regular basis as defined by the organization's bylaws. The board sets the vision through
1292-579: The process of evaluating the Pfizer–BioNTech COVID-19 vaccine in December 2020, the EMA suffered a cyberattack , resulting in the leak of classified regulatory documents to journalists, academics and the public via the dark web . The documents revealed internal concerns about low production quality in the mRNA vaccine candidate, and regulators' efforts to have Pfizer and BioNTech rectify these deficiencies. The EMA ultimately authorized
1330-588: The subsequent vote (thirteen votes each), after which a drawing of lots identified Amsterdam as the host city of EMA. EMA staff left its London premises in March 2019 to relocate to a temporary building in Amsterdam, and by January 2020 the relocation to the permanent building in Amsterdam Zuidas district was finalised. The EMA played a significant role in the response to the COVID-19 pandemic in
1368-469: The vaccine on 21 December 2020, satisfied that the product quality was "sufficiently consistent and acceptable." As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), but without centralisation . The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate
1406-505: Was located in London prior to the United Kingdom's vote for withdrawal from the European Union , relocating to Amsterdam in March 2019. The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority ) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. More specifically, it coordinates
1444-445: Was that this plan would not only reduce the €350 million annual cost drug companies incurred by having to win separate approvals from each member state but also that it would eliminate the protectionist tendencies of Sovereign states unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EMA was founded after more than seven years of negotiations among EU governments and replaced
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