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Change control is a critical component of regulatory affairs in various industries, particularly in pharmaceuticals, medical devices, and biotechnology. This research paper explores the challenges associated with traditional change control processes and presents best practices for streamlining these processes to improve efficiency, compliance, and overall product quality. Through a comprehensive literature review and analysis of case studies from leading organizations, we identify key strategies for optimizing change control workflows, leveraging technology, and fostering a culture of continuous improvement. The paper also examines the impact of streamlined change control processes on regulatory compliance, product lifecycle management, and organizational performance. Our findings suggest that implementing these best practices can lead to significant reductions in change implementation time, improved regulatory compliance, and enhanced product quality and safety.

Change control is a critical component of regulatory affairs in various industries, particularly in pharmaceuticals, medical devices, and biotechnology. This research paper explores the challenges associated with traditional change control processes and presents best practices for streamlining these processes to improve efficiency, compliance, and overall product quality. Through a comprehensive literature review and analysis of case studies from leading organizations, we identify key strategies for optimizing change control workflows, leveraging technology, and fostering a culture of continuous improvement. The paper also examines the impact of streamlined change control processes on regulatory compliance, product lifecycle management, and organizational performance. Our findings suggest that implementing these best practices can lead to significant reductions in change implementation time, improved regulatory compliance, and enhanced product quality and safety.

Change control is a critical component of regulatory affairs in various industries, particularly in pharmaceuticals, medical devices, and biotechnology. This research paper explores the challenges associated with traditional change control processes and presents best practices for streamlining these processes to improve efficiency, compliance, and overall product quality. Through a comprehensive literature review and analysis of case studies from leading organizations, we identify key strategies for optimizing change control workflows, leveraging technology, and fostering a culture of continuous improvement. The paper also examines the impact of streamlined change control processes on regulatory compliance, product lifecycle management, and organizational performance. Our findings suggest that implementing these best practices can lead to significant reductions in change implementation time, improved regulatory compliance, and enhanced product quality and safety.

The market placing of a medical device in compliance with the requirements of EU Regulation 2017/745 (Medical Device Regulation) demands advanced regulatory expertise and a high level of detail and depth, inevitably leading to significant human and time resources. In an era where Artificial Intelligence (AI) is already present in various aspects of daily life, the potential and opportunity to use AI tools in the scientific field, such as the CE marking process of medical devices, are being explored. This process consists of several phases and related activities, some of which have been chosen as significant examples to evaluate how and to what extent AI can add value in achieving their compliance. The article presents the overall results in terms of performance and reliability derived from generative AI tests using Large Language Models, such as ChatGPT, applied to some of the processes necessary for the market placing of a medical device. The method used focuses on the relationship between prompt quality and output quality, demonstrating the importance of prompt engineering in using these tools effectively alongside regulatory processes. It also emphasizes the need for end-users to have education, training, and understanding of the mechanisms of generative AI to optimize performance.

Regional administrative data may help public administrations in organizing their information, identifying problems, defining solutions and verifying results of the actions taken. The objective of this work is to present the discussion output of the working group (GDL) “The use of regional pharmaceutical data to facilitate health planning and outcome monitoring” which was held during the Regional Pharmaceutical Policy Forum of 2023. The GDL focused on identifying a model for planning, programming and monitoring health resources based on the data-driven approach and on the use of already existing regional administrative data, defining some gaps and developing proposals to implement this strategy. In particular, were highlighted the needs to adopt a broader perspective that considers healthcare costs as a whole (and not, specifically, oriented towards the governance of pharmaceutical assistance), to create ad-hoc training courses focused on the use of real-world data, and, similarly to some European Countries, to move towards an open access policy (accessible data) that can be useful to improve citizens’ health protection services, in compliance with the GDPR.

Se presenta una guía para la integración del sistema de gestión de calidad de dispositivos médicos clase I y IIA y los aspectos regulatorios en el marco colombiano, aplicables en el diseño, desarrollo, fabricación, comercialización y exportación de Dispositivos Médicos. Se efectuó una investigación del normograma vigente en las bases de datos del Invima y el Ministerio de Salud y Protección Social, se revisó el estándar NTC-ISO 13485:2016; se hicieron indagaciones en artículos en bases de datos electrónicas, consultas técnicas al Invima respecto a la interpretación de la regulación y a expertos en el sector. Este estudio y la guía de aplicación permitieron identificar metodologías y recomendaciones prácticas para el sector, al otorgar las recomendaciones basadas en comentarios de expertos en el mismo, además lleva a fortalecer los conocimientos como guía a las empresas fabricantes de dispositivos médicos en Colombia., A guide is presented for the integration of the quality management system of class I and IIA medical devices and the regulatory aspects in the Colombian framework, applicable in the design, development, manufacture, commercialization and export of Medical Devices. An investigation of the current normogram was carried out in the databases of Invima and the Ministry of Health and Social Protection, the NTC-ISO 13485:2016 standard was reviewed; Inquiries were made in articles in electronic databases, technical consultations with Invima regarding the interpretation of the regulation and experts in the sector. This study and the application guide made it possible to identify methodologies and practical recommendations for the sector, by granting recommendations based on comments from experts in it, also leading to strengthening knowledge as a guide to medical device manufacturing companies in Colombia.

Climate is the average weather of an area. It is the general weather conditions, seasonal variations of a region. The average of such conditions over a long period is called climate. The earth’s average surface temperature and climate have been changing throughout the world. Sometimes the temperature has changed gradually and at other times quickly. We have relatively stable climate for thousands of years due to which we have practiced agriculture. Even a small changes in climate conditions may disturb agriculture that would lead to migration of human, birds and animals. High CO2 level in the atmosphere have a negative effects on crop production and forest growth. Climate change may upset the water cycle results in floods and droughts in different parts of the world. Presence of greenhouse gases in the atmosphere increases the global temperature. Depletion of ozone layer also increases the global temperature. As the earth becomes warmer, there would be increase in waterborne diseases, infectious diseases carried by mosquitoes. The climate change might cause decline in ecosystem. Human health has always been influenced by climate and weather. Changes in climate and climate variability affect the environment that provides us with clean air, food, freshwater, shelter security. Climate change threatens human health in numerous ways. Some of these health impacts are already being experienced in the world. Adverse health effects attributed to climate change can have many economic and social consequences, including direct medical costs, work loss, increased care giving and other limitations on everyday activities. In addition, the effects of global climate change on mental health. Human influencehas been the dominant cause of this observed climate change resulting increases in the intensity of some extreme weather events, rising sea levels andmelting snow are already disrupting people’s lives and damaging economy. The impacts of climate change are projected to increase ove

Climate is the average weather of an area. It is the general weather conditions, seasonal variations of a region. The average of such conditions over a long period is called climate. The earth’s average surface temperature and climate have been changing throughout the world. Sometimes the temperature has changed gradually and at other times quickly. We have relatively stable climate for thousands of years due to which we have practiced agriculture. Even a small changes in climate conditions may disturb agriculture that would lead to migration of human, birds and animals. High CO2 level in the atmosphere have a negative effects on crop production and forest growth. Climate change may upset the water cycle results in floods and droughts in different parts of the world. Presence of greenhouse gases in the atmosphere increases the global temperature. Depletion of ozone layer also increases the global temperature. As the earth becomes warmer, there would be increase in waterborne diseases, infectious diseases carried by mosquitoes. The climate change might cause decline in ecosystem. Human health has always been influenced by climate and weather. Changes in climate and climate variability affect the environment that provides us with clean air, food, freshwater, shelter security. Climate change threatens human health in numerous ways. Some of these health impacts are already being experienced in the world. Adverse health effects attributed to climate change can have many economic and social consequences, including direct medical costs, work loss, increased care giving and other limitations on everyday activities. In addition, the effects of global climate change on mental health. Human influencehas been the dominant cause of this observed climate change resulting increases in the intensity of some extreme weather events, rising sea levels andmelting snow are already disrupting people’s lives and damaging economy. The impacts of climate change are projected to increase ove

These days, finding new marketing authorizations, guaranteeing regulatory compliance, and keeping labour costs competitive are extremely tough. Many pharmaceutical companies also struggle to deal with local regulatory issues and stay up with changes in key pharmaceutical markets. Regulations are thoroughly reviewed before being given to the RA department. This team compiles the most critical prescription information for global approval and marketing. This category accepts both new and revised product submissions. This is mostly handled by the RA department. RA's job is to provide feedback on proposed or disputed legislation. This is a proactive measure. The ICH framework allows for more early intervention. Regulators have a wide range of responsibilities. In the US, the FDA must register and clear the goods with the export company's regulatory professional.

These days, finding new marketing authorizations, guaranteeing regulatory compliance, and keeping labour costs competitive are extremely tough. Many pharmaceutical companies also struggle to deal with local regulatory issues and stay up with changes in key pharmaceutical markets. Regulations are thoroughly reviewed before being given to the RA department. This team compiles the most critical prescription information for global approval and marketing. This category accepts both new and revised product submissions. This is mostly handled by the RA department. RA's job is to provide feedback on proposed or disputed legislation. This is a proactive measure. The ICH framework allows for more early intervention. Regulators have a wide range of responsibilities. In the US, the FDA must register and clear the goods with the export company's regulatory professional.

These days, finding new marketing authorizations, guaranteeing regulatory compliance, and keeping labour costs competitive are extremely tough. Many pharmaceutical companies also struggle to deal with local regulatory issues and stay up with changes in key pharmaceutical markets. Regulations are thoroughly reviewed before being given to the RA department. This team compiles the most critical prescription information for global approval and marketing. This category accepts both new and revised product submissions. This is mostly handled by the RA department. RA's job is to provide feedback on proposed or disputed legislation. This is a proactive measure. The ICH framework allows for more early intervention. Regulators have a wide range of responsibilities. In the US, the FDA must register and clear the goods with the export company's regulatory professional. &nbsp

These days, finding new marketing authorizations, guaranteeing regulatory compliance, and keeping labour costs competitive are extremely tough. Many pharmaceutical companies also struggle to deal with local regulatory issues and stay up with changes in key pharmaceutical markets. Regulations are thoroughly reviewed before being given to the RA department. This team compiles the most critical prescription information for global approval and marketing. This category accepts both new and revised product submissions. This is mostly handled by the RA department. RA's job is to provide feedback on proposed or disputed legislation. This is a proactive measure. The ICH framework allows for more early intervention. Regulators have a wide range of responsibilities. In the US, the FDA must register and clear the goods with the export company's regulatory professional. &nbsp

These days, finding new marketing authorizations, guaranteeing regulatory compliance, and keeping labour costs competitive are extremely tough. Many pharmaceutical companies also struggle to deal with local regulatory issues and stay up with changes in key pharmaceutical markets. Regulations are thoroughly reviewed before being given to the RA department. This team compiles the most critical prescription information for global approval and marketing. This category accepts both new and revised product submissions. This is mostly handled by the RA department. RA's job is to provide feedback on proposed or disputed legislation. This is a proactive measure. The ICH framework allows for more early intervention. Regulators have a wide range of responsibilities. In the US, the FDA must register and clear the goods with the export company's regulatory professional. &nbsp

MedTech firms experience barriers when entering the healthcare sector, although their solutions could solve healthcare challenges. The study provides a conceptual framework for MedTech firms' business environment including institutional alignments and misalignments. These insights support MedTech firms' business model development when aiming for successful commercialization. The research is conducted with a multiple case study analyzing MedTech firms' and healthcare organizations' perspective regarding the business environment and relationship dynamics. The study generated three main findings. Firstly, an organizational and institutional logic analysis outlined essential problem areas where MedTech firms and healthcare organizations align differently. Secondly, suggestions on how the MedTech firm can respond to the identified problem areas through their business model are presented. Thirdly, the study provides an example of how social- and business literature can be connected to understand complex business environments. In contrast to a majority of prior research, the study is designed for the MedTech firm's perspective where the final result answering how the business model can be improved based on healthcare organizational and business insights.

MedTech firms experience barriers when entering the healthcare sector, although their solutions could solve healthcare challenges. The study provides a conceptual framework for MedTech firms' business environment including institutional alignments and misalignments. These insights support MedTech firms' business model development when aiming for successful commercialization. The research is conducted with a multiple case study analyzing MedTech firms' and healthcare organizations' perspective regarding the business environment and relationship dynamics. The study generated three main findings. Firstly, an organizational and institutional logic analysis outlined essential problem areas where MedTech firms and healthcare organizations align differently. Secondly, suggestions on how the MedTech firm can respond to the identified problem areas through their business model are presented. Thirdly, the study provides an example of how social- and business literature can be connected to understand complex business environments. In contrast to a majority of prior research, the study is designed for the MedTech firm's perspective where the final result answering how the business model can be improved based on healthcare organizational and business insights.

The fashion industry is not only known for its creativity and innovation, but also for its contribution to environmental pollution, climate change as well as for social imbalances and poverty. Ecological and societal standards have so far only played a minor role in this industry for production and distribution as well as for consumers for their consumption and disposal behaviour. However, in order to achieve the UN Sustainable Development Goals and prevent the maximum damage caused by pollution and exploitation, it is necessary to act more rapidly and consistently. Governmental control instruments can help to address those responsible, to regulate the market and to encourage improvements towards a more sustainable economy. The aim of this work is to develop a feasible governmental control instrument for the textile sector in order to provide possible solutions for some of the existing problems. Three different cases of already implemented policies in the food sector will be analysed and evaluated in order to detect the best-case policy with regard to sustainability as a basis for a derivation. The findings of the derived outcome will then be examined by experts in order to validate it. Finally, a recommendation summarises the findings of the literature review, the transfer of knowledge as well as the expert assessments. The result of this research paper is a control instrument derived from the food industry, which was evaluated with the help of expert interviews and has the potential to make the textile market more sustainable in the long term.

The fashion industry is not only known for its creativity and innovation, but also for its contribution to environmental pollution, climate change as well as for social imbalances and poverty. Ecological and societal standards have so far only played a minor role in this industry for production and distribution as well as for consumers for their consumption and disposal behaviour. However, in order to achieve the UN Sustainable Development Goals and prevent the maximum damage caused by pollution and exploitation, it is necessary to act more rapidly and consistently. Governmental control instruments can help to address those responsible, to regulate the market and to encourage improvements towards a more sustainable economy. The aim of this work is to develop a feasible governmental control instrument for the textile sector in order to provide possible solutions for some of the existing problems. Three different cases of already implemented policies in the food sector will be analysed and evaluated in order to detect the best-case policy with regard to sustainability as a basis for a derivation. The findings of the derived outcome will then be examined by experts in order to validate it. Finally, a recommendation summarises the findings of the literature review, the transfer of knowledge as well as the expert assessments. The result of this research paper is a control instrument derived from the food industry, which was evaluated with the help of expert interviews and has the potential to make the textile market more sustainable in the long term.

The European Medicines Agency (EMA) has adopted assessment systems and drug registration procedures to respond to the needs for rapid patient access to therapies, such as Conditional Marketing Approval (CMA) and Under Exceptional Circumstances approval (UEC). The Italian Medicine Agency (AIFA) has introduced tools for governing prescriptive behaviour in order to promote appropriateness and correct use of drugs and to manage the uncertainty of financial impact, including Managed Entry Agreements (MEAs). The MEAs are conditional access agreements to the market for new drugs aimed at managing the uncertainty on the clinical and economic effects of the drugs themselves. The aim of this study is to analyse, through the use of the information systems of the AIFA and the institutional website of the EMA, how the drugs authorised by EMA with CMA or UEC have been managed on the access side to the Italian NHS. This in order to understand how the uncertainty deriving from the authorisation processes was subsequently reflected on the reimbursement processes to be borne by the NHS. From the analyses carried out, it emerges that 64% of the drugs approved with CMA were admitted to reimbursement and 68% of those approved with the UEC procedure. Furthermore, it can be noted that approval with CMA is predictive for the application of a financial-based or outcome-based MEA (61%), with the application of a monitoring register, unlike the drugs approved UEC for which no conditional reimbursement arrangements have been applied at the patient level. Furthermore, by carrying out a comparative analysis of the time of access to market following negotiation, from the positive opinion of the CHMP to the decision published in the Official Gazette of the Italian Republic, it emerged that the drugs approved by the UEC procedure take on average more time (897 days) to arrive at the price and reimbursement (P&R) compared to CMA drugs (636 days). Considering instead only the period from the request

The European Medicines Agency (EMA) has adopted assessment systems and drug registration procedures to respond to the needs for rapid patient access to therapies, such as Conditional Marketing Approval (CMA) and Under Exceptional Circumstances approval (UEC). The Italian Medicine Agency (AIFA) has introduced tools for governing prescriptive behaviour in order to promote appropriateness and correct use of drugs and to manage the uncertainty of financial impact, including Managed Entry Agreements (MEAs). The MEAs are conditional access agreements to the market for new drugs aimed at managing the uncertainty on the clinical and economic effects of the drugs themselves. The aim of this study is to analyse, through the use of the information systems of the AIFA and the institutional website of the EMA, how the drugs authorised by EMA with CMA or UEC have been managed on the access side to the Italian NHS. This in order to understand how the uncertainty deriving from the authorisation processes was subsequently reflected on the reimbursement processes to be borne by the NHS. From the analyses carried out, it emerges that 64% of the drugs approved with CMA were admitted to reimbursement and 68% of those approved with the UEC procedure. Furthermore, it can be noted that approval with CMA is predictive for the application of a financial-based or outcome-based MEA (61%), with the application of a monitoring register, unlike the drugs approved UEC for which no conditional reimbursement arrangements have been applied at the patient level. Furthermore, by carrying out a comparative analysis of the time of access to market following negotiation, from the positive opinion of the CHMP to the decision published in the Official Gazette of the Italian Republic, it emerged that the drugs approved by the UEC procedure take on average more time (897 days) to arrive at the price and reimbursement (P&R) compared to CMA drugs (636 days). Considering instead only the period from the requ, The European Medicines Agency (EMA) has adopted assessment systems and drug registration procedures to respond to the needs for rapid patient access to therapies, such as Conditional Marketing Approval (CMA) and Under Exceptional Circumstances approval (UEC). The Italian Medicine Agency (AIFA) has introduced tools for governing prescriptive behaviour in order to promote appropriateness and correct use of drugs and to manage the uncertainty of financial impact, including Managed Entry Agreements (MEAs). The MEAs are conditional access agreements to the market for new drugs aimed at managing the uncertainty on the clinical and economic effects of the drugs themselves. The aim of this study is to analyse, through the use of the information systems of the AIFA and the institutional website of the EMA, how the drugs authorised by EMA with CMA or UEC have been managed on the access side to the Italian NHS. This in order to understand how the uncertainty deriving from the authorisation processes was subsequently reflected on the reimbursement processes to be borne by the NHS. From the analyses carried out, it emerges that 64% of the drugs approved with CMA were admitted to reimbursement and 68% of those approved with the UEC procedure. Furthermore, it can be noted that approval with CMA is predictive for the application of a financial-based or outcome-based MEA (61%), with the application of a monitoring register, unlike the drugs approved UEC for which no conditional reimbursement arrangements have been applied at the patient level. Furthermore, by carrying out a comparative analysis of the time of access to market following negotiation, from the positive opinion of the CHMP to the decision published in the Official Gazette of the Italian Republic, it emerged that the drugs approved by the UEC procedure take on average more time (897 days) to arrive at the price and reimbursement (P&R) compared to CMA drugs (636 days). Considering instead only the period from the requ

The purpose of this study was to investigate what kind of regulatory affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries. The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany, and Spain, focusing on those companies that undertake regulatory affairs. The survey received 71 completed responses out of 147, a response rate of 48 %. The most outsourced tasks were related to translations of product information texts (75 % of the respondents). The principal reason for outsourcing regulatory affairs tasks to a Contract Research Organization (CRO) was the excessively heavy workload in the company's regulatory affairs. Also, outsourcing should be cost-effective. The fact that the CRO has experience and knowledge was seen as a very important requirement when choosing the CRO partner. Personal, individual contacts were mentioned in many of the open-ended responses as an essential criterion in the selection of the CRO. This survey indicated that outsourcing in regulatory affairs will continue. The quality of the CRO has a significant role when the companies select their partner. The CRO has to assure uniform quality of their personnel knowledge and skills in regulatory affairs, i.e., when the person in charge of the outsourced task changes in the CRO. Practically all product development steps can be outsourced by hiring local and multinational CROs. The companies should plan the outsourcing carefully and compare possible CROs even if the company has no plans to outsource at present.

Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type “gastrointestinal disorders” and “nervous system disorders”. Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

Objective: To encourage the development of drugs for rare diseases, orphan drug legislation has been introduced in the USA (1983) and in the EU (2000). Recent literature discusses factors that may influence the development of new orphan medicinal products in the EU. This study aims to identify predictors for successful marketing authorisation of potential orphan drugs in the EU. Methods: A comparison between randomly selected authorised and a matched sample of not-yet-authorised orphan drug designations has been performed. Determinants in the study included characteristics of the indication, of the product and of the sponsor. Data were collected from the public domain only. Results: Orphan drug approval was strongly associated with previous experience of the sponsor in obtaining approval for another orphan drug (OR=17.3, 95% CI=5.6-53.1). Furthermore, existing synthetic entities compared to biotechnology products tended to have a higher likelihood of reaching approval status (OR=3.9, 95% CI=0.9-16.6). Conclusion: This study showed that experience of a company in developing orphan drugs is an important predictor for subsequent authorisation of other orphan drugs. The same applies for existing (synthetic) molecules, for which much knowledge is available. Further research should be directed towards studying the quality of the clinical development program of those designated orphan medicinal products not reaching approval status.