wanyu/IteraTeR_v2 huggingface dataset:
Original:  Indeed, the risks that are documented in a pre-authorization RMP will inevitably become part of the product's post-marketing labeling.
Revised:  Indeed, the risks that are documented in a pre-authorization risk management plan will inevitably become part of the product's post-marketing labeling.
Edit intent: clarity
Original:  Since a drug, once authorized, may be used in ways not originally studied in clinical trials, this potential "off-label use", and its associated risks, is also described within the RMP. RMPs can be very lengthy documents, running in some cases hundreds of pages and, in rare instances, up to a thousand pages long.
Revised:  Since a drug, once authorized, may be used in ways not originally studied in clinical trials, this potential "off-label use", and its associated risks, is also described within the risk management plan. Risk management plans can be very lengthy documents, running in some cases hundreds of pages and, in rare instances, up to a thousand pages long.
Edit intent: clarity
Original:  In the US, under certain circumstances, the FDA may require a company to submit a document called a Risk Evaluation and Mitigation Strategies (REMS) for a drug that has a specific risk that FDA believes requires mitigation.
Revised:  In the US, under certain circumstances, the FDA may require a company to submit a document called a Risk Evaluation and Mitigation Strategy (REMS) for a drug that has a specific risk that FDA believes requires mitigation.
Edit intent: fluency
Original:  While not as comprehensive as an RMP, a REMS can require a sponsor to perform certain activities or to follow a protocol, referred to as Elements to Assure Safe Use (ETASU) , to assure that a positive risk-benefit profile for the drug is maintained for the circumstances under which the product is marketed.
Revised:  While not as comprehensive as a risk management plan, a Risk Evaluation and Mitigation Strategy can require a sponsor to perform certain activities or to follow a protocol, referred to as Elements to Assure Safe Use (ETASU) , to assure that a positive risk-benefit profile for the drug is maintained for the circumstances under which the product is marketed.
Edit intent: clarity
Original:  While not as comprehensive as an RMP, a REMS can require a sponsor to perform certain activities or to follow a protocol, referred to as Elements to Assure Safe Use (ETASU) , to assure that a positive risk-benefit profile for the drug is maintained for the circumstances under which the product is marketed.
Revised:  While not as comprehensive as an RMP, a REMS can require a sponsor to perform certain activities or to follow a protocol, referred to as Elements to Assure Safe Use , to assure that a positive risk-benefit profile for the drug is maintained for the circumstances under which the product is marketed.
Edit intent: clarity
Original:  The International Council for Harmonisation (ICH) The ICH is a global organization with members from the European Union, the United States and Japan;
Revised:  The International Council for Harmonisation The International Council for Harmonisation is a global organization with members from the European Union, the United States and Japan;
Edit intent: clarity
Original:  overseeing harmonization URL Established in 1990, each of its six co-sponsors—the EU, the European Federation of Pharmaceutical Industries and Associations (EFPIA) , Japan's Ministry of Health, Labor and Welfare (MHLW) , the Japanese Pharmaceutical Manufacturers Association (JPMA) , the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)—have two seats on the SC.
Revised:  overseeing harmonization URL Established in 1990, each of its six co-sponsors—the EU, the European Federation of Pharmaceutical Industries and Associations , Japan's Ministry of Health, Labor and Welfare (MHLW) , the Japanese Pharmaceutical Manufacturers Association (JPMA) , the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)—have two seats on the SC.
Edit intent: clarity
Original:  overseeing harmonization URL Established in 1990, each of its six co-sponsors—the EU, the European Federation of Pharmaceutical Industries and Associations (EFPIA) , Japan's Ministry of Health, Labor and Welfare (MHLW) , the Japanese Pharmaceutical Manufacturers Association (JPMA) , the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)—have two seats on the SC.
Revised:  overseeing harmonization URL Established in 1990, each of its six co-sponsors—the EU, the European Federation of Pharmaceutical Industries and Associations (EFPIA) , Japan's Ministry of Health, Labor and Welfare , the Japanese Pharmaceutical Manufacturers Association (JPMA) , the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)—have two seats on the SC.
Edit intent: clarity
Original:  overseeing harmonization URL Established in 1990, each of its six co-sponsors—the EU, the European Federation of Pharmaceutical Industries and Associations (EFPIA) , Japan's Ministry of Health, Labor and Welfare (MHLW) , the Japanese Pharmaceutical Manufacturers Association (JPMA) , the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)—have two seats on the SC.
Revised:  overseeing harmonization URL Established in 1990, each of its six co-sponsors—the EU, the European Federation of Pharmaceutical Industries and Associations (EFPIA) , Japan's Ministry of Health, Labor and Welfare (MHLW) , the Japanese Pharmaceutical Manufacturers Association , the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)—have two seats on the SC.
Edit intent: clarity
Original:  Other parties have a significant interest in ICH and have been invited to nominate Observers to the SC;
Revised:  Other parties have a significant interest in the International Council for Harmonisation and have been invited to nominate Observers to the SC;
Edit intent: clarity
Original:  three current observers are the WHO, Health Canada, and the European Free Trade Association (EFTA) , with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) participating as a non-voting member of the SC.
Revised:  three current observers are the WHO, Health Canada, and the European Free Trade Association , with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) participating as a non-voting member of the SC.
Edit intent: clarity
Original:  three current observers are the WHO, Health Canada, and the European Free Trade Association (EFTA) , with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) participating as a non-voting member of the SC.
Revised:  three current observers are the WHO, Health Canada, and the European Free Trade Association (EFTA) , with the International Federation of Pharmaceutical Manufacturers Association participating as a non-voting member of the SC.
Edit intent: clarity
Original:  The International Society of Pharmacovigilance (ISoP) The ISoP is an international non-profit scientific organization, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries.
Revised:  The International Society of Pharmacovigilance The International Society of Pharmacovigilance is an international non-profit scientific organization, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries.
Edit intent: clarity
Original:  China's regulation of PV is through its National Center for Adverse Drug Reaction (ADR) Monitoring, under China's Ministry of Health.
Revised:  China's regulation of PV is through its National Center for Adverse Drug Reaction Monitoring, under China's Ministry of Health.
Edit intent: clarity
Original:  PV efforts in the EU are coordinated by the European Medicines Agency (EMA) and are conducted by the national competent authorities (NCAs).
Revised:  PV efforts in the EU are coordinated by the European Medicines Agency and are conducted by the national competent authorities (NCAs).
Edit intent: clarity
Original:  The main responsibility of the EMA is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed in the European Community;
Revised:  The main responsibility of the European Medicines Agency is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed in the European Community;
Edit intent: clarity
Original: "Safety monitoring of medicines" European Medicines Agency The EMA requires the individual marketing authorization holders to submit all received adverse reactions in electronic form, except in exceptional circumstances;
Revised: "Safety monitoring of medicines" European Medicines Agency The European Medicines Agency requires the individual marketing authorization holders to submit all received adverse reactions in electronic form, except in exceptional circumstances;
Edit intent: clarity
Original:  For instance, in Spain, PV is regulated by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), a legal entity that retains the right to suspend or withdraw the authorization of pharmaceuticals already on-market if the evidence shows that safety (or quality or efficacy) of an agent are unsatisfactory.
Revised:  For instance, in Spain, PV is regulated by the Agencia Española de Medicamentos y Productos Sanitarios , which can suspend or withdraw the authorization of pharmaceuticals already on-market if the evidence shows that safety (or quality or efficacy) of an agent are unsatisfactory.
Edit intent: clarity
Original:  In Japan, with ~12\% of all global 2011 pharmaceutical expenditures, PV matters are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA)
Revised:  In Japan, with ~12\% of all global 2011 pharmaceutical expenditures, PV matters are regulated by the Pharmaceuticals and Medical Devices Agency 
Edit intent: clarity
Original:  and the Ministry of Health, Labour, and Welfare MHLW . In Canada, with ~2\% of all global 2006 and 2011 pharmaceutical expenditures, PV is regulated by the Marketed Health Products Directorate of the Health Products and Food Branch (MHPD) . Canada was second, following the United States, in holding the highest total prescription drug expenditures per capita in 2011 at around 750 US dollars per person.
Revised:  and the Ministry of Health, Labour, and Welfare . In Canada, with ~2\% of all global 2006 and 2011 pharmaceutical expenditures, PV is regulated by the Marketed Health Products Directorate of the Health Products and Food Branch (MHPD) . Canada was second, following the United States, in holding the highest total prescription drug expenditures per capita in 2011 at around 750 US dollars per person.
Edit intent: clarity
Original:  and the Ministry of Health, Labour, and Welfare MHLW . In Canada, with ~2\% of all global 2006 and 2011 pharmaceutical expenditures, PV is regulated by the Marketed Health Products Directorate of the Health Products and Food Branch (MHPD) . Canada was second, following the United States, in holding the highest total prescription drug expenditures per capita in 2011 at around 750 US dollars per person.
Revised:  and the Ministry of Health, Labour, and Welfare MHLW . In Canada, with ~2\% of all global 2006 and 2011 pharmaceutical expenditures, PV is regulated by the Marketed Health Products Directorate of the Health Products and Food Branch . Canada was second, following the United States, in holding the highest total prescription drug expenditures per capita in 2011 at around 750 US dollars per person.
Edit intent: clarity
Original:  It was also accessed that Canada was one of the top countries that increased its yearly average per capita growth on pharmaceutical expenditures the most from 2000-2010 with 4 percent a year (with taking inflation into account) The MHPD mainly collects adverse drug reaction reports through a network of reporting centers to analyze and issue possible warnings to the public, and currently utilizes newsletters, advisories, adverse reaction centers, as well as electronic mailing lists.
Revised:  It was also accessed that Canada was one of the top countries that increased its yearly average per capita growth on pharmaceutical expenditures the most from 2000-2010 with 4 percent a year (with taking inflation into account) The Marketed Health Products Directorate mainly collects adverse drug reaction reports through a network of reporting centers to analyze and issue possible warnings to the public, and currently utilizes newsletters, advisories, adverse reaction centers, as well as electronic mailing lists.
Edit intent: clarity
Original:  The Republic of Korea, with ~1\% of all global 2011 pharmaceutical expenditures, PV matters are regulated in South Korea by the Ministry Of Food And Drug Safety (MFDS) Rest of world (ROW) ROW accrued ~7\% of global 2011 pharmaceutical expenditures.
Revised:  The Republic of Korea, with ~1\% of all global 2011 pharmaceutical expenditures, PV matters are regulated in South Korea by the Ministry Of Food And Drug Safety Rest of world (ROW) ROW accrued ~7\% of global 2011 pharmaceutical expenditures.
Edit intent: clarity
Original:  The Republic of Korea, with ~1\% of all global 2011 pharmaceutical expenditures, PV matters are regulated in South Korea by the Ministry Of Food And Drug Safety (MFDS) Rest of world (ROW) ROW accrued ~7\% of global 2011 pharmaceutical expenditures.
Revised:  The Republic of Korea, with ~1\% of all global 2011 pharmaceutical expenditures, PV matters are regulated in South Korea by the Ministry Of Food And Drug Safety (MFDS) Rest of world ROW accrued ~7\% of global 2011 pharmaceutical expenditures.
Edit intent: clarity
Original:  The Republic of Korea, with ~1\% of all global 2011 pharmaceutical expenditures, PV matters are regulated in South Korea by the Ministry Of Food And Drug Safety (MFDS) Rest of world (ROW) ROW accrued ~7\% of global 2011 pharmaceutical expenditures.
Revised:  The Republic of Korea, with ~1\% of all global 2011 pharmaceutical expenditures, PV matters are regulated in South Korea by the Ministry Of Food And Drug Safety (MFDS) Rest of world (ROW) The rest of the world accrued ~7\% of global 2011 pharmaceutical expenditures.
Edit intent: clarity
Original:  Some examples of PV regulatory agencies in ROW are as follows.
Revised:  Some examples of PV regulatory agencies in the rest of the world are as follows.
Edit intent: clarity
Original:  (Ecopharmacovigilance EPV ) Despite attention from the FDA and regulatory agencies of the European Union, procedures for monitoring drug concentrations and adverse effects in the environment are lacking.
Revised:  (Ecopharmacovigilance (Ecopharmacovigilance ) Despite attention from the FDA and regulatory agencies of the European Union, procedures for monitoring drug concentrations and adverse effects in the environment are lacking.
Edit intent: clarity
Original:  A concept combining pharmacovigilance and environmental pharmacology, intended to focus attention on this area, was introduced first as pharmacoenvironmentology in 2006 by Syed Ziaur Rahman and later as ecopharmacology with further concurrent and later terms for the same concept (ecopharmacovigilance %DIFDELCMD < [%%% EPV , environmental pharmacology, ecopharmacostewardship).
Revised:  A concept combining pharmacovigilance and environmental pharmacology, intended to focus attention on this area, was introduced first as pharmacoenvironmentology in 2006 by Syed Ziaur Rahman and later as ecopharmacology with further concurrent and later terms for the same concept (ecopharmacovigilance %DIFDELCMD < [%%% , environmental pharmacology, ecopharmacostewardship).
Edit intent: clarity
Original:  The first of these routes to the environment, elimination through living organisms subsequent to pharmacotherapy, is suggested as the principal source of environmental contamination (apart from cases where norms for treatment of manufacturing and other wastes are violated), and EPV is intended to deal specifically with this impact of pharmacological agents on the environment.
Revised:  The first of these routes to the environment, elimination through living organisms subsequent to pharmacotherapy, is suggested as the principal source of environmental contamination (apart from cases where norms for treatment of manufacturing and other wastes are violated), and ecopharmacovigilance is intended to deal specifically with this impact of pharmacological agents on the environment.
Edit intent: clarity
Original:  Activities of EPV have been suggested to include: Increasing, generally, the availability of environmental data on medicinal products;
Revised:  Activities of ecopharmacovigilance have been suggested to include: Increasing, generally, the availability of environmental data on medicinal products;
Edit intent: clarity
Original:  Using Environmental Risk Management Plans (ERMPs) to manage risk throughout a drug's life cycle;
Revised:  Using environmental risk management plans to manage risk throughout a drug's life cycle;
Edit intent: clarity
Original:  As such, pharmacovigilance heavily focuses on adverse drug reactions  , which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation).
Revised:  As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR) , which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation).
Edit intent: clarity
Original:  its goal is to recommend global standards for drug companies and drug regulatory authorities around the world, with its activities overseen by the Steering Committee overseeing harmonization activities.
Revised:  its goal is to recommend global standards for drug companies and drug regulatory authorities around the world, with its activities overseen by the Steering Committee overseeing harmonization 
Edit intent: clarity
Original: The activity that is most commonly associated with pharmacovigilance (PV), and which consumes a significant amount of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting.
Revised: The activity that is most commonly associated with pharmacovigilance (PV), and which consumes a significant number of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting.
Edit intent: clarity
Original:  The activities involved in pharmacovigilance are: Case-control study (Retrospective study).
Revised:  Case-control study (Retrospective study).
Edit intent: coherence
Original:  Черкесогаи Северо-Западного Кавказа в XIX в. are ethnic Armenians who have inhabited Russia's Krasnodar Krai and Republic of Adyghea since the end of 15th century and spoke the Adyghe language (currently, most of them speak Russian as their first language), apart from other Armenians living in the region.
Revised:  Черкесогаи Северо-Западного Кавказа в XIX в. are ethnic Armenians who have inhabited Russia's Krasnodar Krai and Republic of Adyghea since the end of 15th century and spoke the Adyghe language (currently, most of them speak Russian as their first language), in contrast to other Armenians living in the region.
Edit intent: clarity
Original:  The formation of the present-day Armenian diaspora in the North Caucasus took place during the 17th and 18th centuries, although the first Hemshin Armenians arrived during the 8th century.
Revised:  Most of the present-day Armenian diaspora in the North Caucasus took place during the 17th and 18th centuries, although the first Hemshin Armenians arrived during the 8th century.
Edit intent: clarity
Original:  The formation of the present-day Armenian diaspora in the North Caucasus took place during the 17th and 18th centuries, although the first Hemshin Armenians arrived during the 8th century.
Revised:  The formation of the present-day Armenian diaspora in the North Caucasus arrived in the 17th and 18th centuries, although the first Hemshin Armenians arrived during the 8th century.
Edit intent: clarity
Original:  The formation of the present-day Armenian diaspora in the North Caucasus took place during the 17th and 18th centuries, although the first Hemshin Armenians arrived during the 8th century.
Revised:  The formation of the present-day Armenian diaspora in the North Caucasus took place during the 17th and 18th centuries, though the first Hemshin Armenians arrived during the 8th century.
Edit intent: fluency
Original:  The formation of the present-day Armenian diaspora in the North Caucasus took place during the 17th and 18th centuries, although the first Hemshin Armenians arrived during the 8th century.
Revised:  The formation of the present-day Armenian diaspora in the North Caucasus took place during the 17th and 18th centuries, although the first Hemshin Armenians arrived in the 8th century.
Edit intent: fluency
Original:  The first took place from the late 1780s to the 1860s, when around 3,000 Armenians came to the region from the Russian towns of Astrakhan, Kizlyar and Mozdok, as well as around 300 Persian Turkish Armenians.
Revised:  The first took place from the late 1780s to the 1860s, when around 3,000 Armenians came from the Russian towns of Astrakhan, Kizlyar and Mozdok, as well as around 300 Persian Turkish Armenians.
Edit intent: clarity
Original:  Armenian communities were also established in larger towns such as Novorossiysk, Anapa and Ekaterinodar.
Revised:  Armenians also established communities in larger towns such as Novorossiysk, Anapa and Ekaterinodar.
Edit intent: clarity
Original:  The second wave of migrants came during the end of the 19th and the beginning of the 20th centuries, when around 30,000 mostly Turkish Hemshin Armenians arrived in the region, along with a few from Persia and Transcaucasia.
Revised:  A second wave of migrants came during the end of the 19th and the beginning of the 20th centuries, when around 30,000 mostly Turkish Hemshin Armenians arrived in the region, along with a few from Persia and Transcaucasia.
Edit intent: fluency
Original:  During this period two different types of migrants can be identified: those who came for economic reasons who were attracted by Russian government and those who were forced to leave due to the oppression and genocide by the Ottoman government.
Revised:  Some came for economic reasons who were attracted by Russian government and those who were forced to leave due to the oppression and genocide by the Ottoman government.
Edit intent: clarity
Original:  During this period two different types of migrants can be identified: those who came for economic reasons who were attracted by Russian government and those who were forced to leave due to the oppression and genocide by the Ottoman government.
Revised:  During this period two different types of migrants can be identified: those who came for economic reasons and were attracted by Russian government and those who were forced to leave due to the oppression and genocide by the Ottoman government.
Edit intent: coherence