Latest news with #ICH
Saudi Gazette
8 hours ago
- Business
- Saudi Gazette
SFDA elected to Management Committee of MedDRA, the 6th global regulatory body
Saudi Gazette report RIYADH — In a move that highlights Saudi Arabia's growing prominence in global pharmaceutical governance, the Saudi Food and Drug Authority (SFDA) has been officially elected to the Management Committee of the Medical Dictionary for Regulatory Activities (MedDRA). The authority has thus become the sixth regulatory authority worldwide to join this prestigious global medical body. This election marks a pivotal milestone for both Saudi Arabia and the international scientific community, reflecting global confidence in the SFDA's regulatory excellence and the Kingdom's strategic role in advancing international harmonization in drug safety and medical product oversight. MedDRA, developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), is a globally recognized standard for coding and analyzing safety data across the lifecycle of pharmaceutical and biopharmaceutical products. It plays a central role in regulatory communication, post-market surveillance, clinical trial reporting, and signal detection. SFDA's election to the MedDRA Steering committee was confirmed during the ICH Management Committee meeting held in Madrid, Spain, from May 11–12, 2025. With this appointment, SFDA joins a group of regulators, including the European Commission, U.S. FDA, UK MHRA, Health Canada, Japan's MHLW and PMDA, alongside the World Health Organization (WHO), which participates as an observer. This strategic appointment reaffirms SFDA's active leadership within ICH working groups, particularly in the areas of medical terminology and pharmacovigilance. Among its most impactful contributions is the linguistic and technical leadership demonstrated in the translation and validation of over 20,000 MedDRA terms into Arabic—a landmark initiative completed between May and October 2022. This achievement significantly facilitates the implementation of MedDRA across Arabic-speaking regions and enhances inclusive pharmacovigilance throughout the MENA region. For CEOs, scientific leaders, and policymakers, this development signals new opportunities to align regulatory frameworks, accelerate clinical development across the region, and enhance data interoperability. SFDA's presence on the MedDRA Steering Committee is not merely symbolic—it serves as a strategic platform for integrating global safety data, advancing regulatory innovation, and sharing best practices. As Saudi Arabia continues to lead in biopharma localization, digital health, and AI-driven pharmacovigilance, SFDA's role in shaping the evolution of MedDRA is set to reinforce the Kingdom's position at the forefront of global health regulation.
Yahoo
13 hours ago
- Business
- Yahoo
FDA Process Validation for Pharmaceutical and Biologics Course (ONLINE EVENT: June 11-12, 2025)
This FDA Process Validation Training session is an interactive online seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail. The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. Process Validation for Pharmaceutical and Biologics Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Process Validation for Pharmaceutical and Biologics" training has been added to offering. This FDA Process Validation Training session is an interactive online seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail. The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. The Process Validation Guidelines (January 2011) and the EU Annex 15: Requirement and Authentication (October 2015) outline the overall values and methods the two controlling bodies reflect suitable elements of process validation for the production of human and animal drugs and biological foodstuffs, including Active Pharmaceutical Ingredients (APIs). This directive aligns Process Validation activities with a product life cycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The life cycle concept, new to this Guidance, links creation and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. This supervision also cares for process development and novelty through sound science and risk management. The new Process Validation Guideline/Practice includes elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phases 2 and 3, and then commercial manufacturing. Some general questions asked by the users of FDA Process Validation Training Here are a few common questions that the trainees attending the FDA Process Validation Training must ask to upgrade their initial knowledge: How can one integrate these two different concepts (Phase-wise and stage-wise)? Where do they merge? Can they exist independently or can they complement each other to improve, figure, and deliver a product that neither alone could? To what extent, the users must use them? Does it follow along with Stage 3? Questions that exist include how one manages special situations including viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests including DNA and host cell protein. The experts for FDA Process Validation Training will address these questions in Stage 2 as presented here. It will include the utilization of Procedure Validation and Phase 1, 2, and 3, where their Guidance mixture and where remain distinct. In particular, Stage 3. Important: The seminar insists that the trainees attending the FDA Process Validation Training plan to bring a multidisciplinary cluster from your Establishment to get the most from this very important seminar. Objectives of Learning for FDA Process Validation Training: Why are these FDA Guidance/EU Guidelines for Industry-Process Validation so significant to the pharmacological and ergonomics industry? Where does the Process Validation commence? How does Stage 1 integrate with Phase 1? What FDA sections are composed and omitted within the "NEW" Process Validation? What are the Three Stages and Where Do They Apply within the NEW Process Validation? The Authentication approaches are included within this Guidance document. The Constitutional and Supervisory Requirements for Procedure Endorsement. An Outline to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation. The Phase 1 Untried Drug Requirements -- What is and What is NOT Required? General Considerations for Process Validation - Stage 2 Process Qualification. Regulatory Strategies for Phases 2 and 3 and their Incorporation within Stages 1 and 2. General Considerations for Process Validation - Stage 3 Continued Process Verification. An Appraisal of EU Annex 15 and its Comparison to FDA's Process Validation Direction. Who Should Attend: Quality Control Project Management Quality Assurance Product Development Regulatory Compliance Product Development Industrial and Amenities specialists who need to grow and participate in developing understanding regarding the issues surrounding Method Endorsement. Key Topics Covered: Day 1 Overview, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry What is included in the "New" Process Validation (PV) Guidance? The Constitutional and Supervisory Requirements for "PV" Interaction of the Three Stages with Procedure Validation General Considerations for 'PV" - Stage 1 Stage 2 - Phase 1. History and Controlling Basis Authentication Methods, cGMPs in Scientific Supply Manufacture, What's Included within Phase 1, Stage 2 A Review of Industrial Deliberations Special Industrial Situations within Phase 1 Multi-Product Amenities and their Organization Management of Organic and Biotechnology Amenities Management of Sterile Products/Aseptically Produced Products The Necessities of Phase 1 Investigational Medication Necessities How does One Understand and Utilize Them? Regulatory Strategies for Phases 2 and 3 and their Incorporation within Stages 1 and 2 Operation of Procedure Design to Regulate its Duplicability Competences Organization of Amenities, Apparatus, and Values Requirement Day 2 General Deliberations for Procedure Authentication - Stage 2 Process Qualifications Requirement of Values and Gear Expansion of Ecological or Conservational Monitoring Development of Amenities Project Water Systems Development Special Deliberations for Procedure Authentication - Stage 2 Appraisal of Special Study Protocols Studying the Special Requirements of Phase 2/3 Stage 2 Overall Considerations for Process Validation - Stage 3 Sustained Process Corroboration Promising Continued Process Confirmation Remains in Control Use of Cautionary Letters as Instances A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance A Demonstration of Similarity Between the Two Simultaneous Issue of Process Presentation Qualification (PPQ) Batches Rationalizes Why it Requires being Accompanied by a Systematic Critical Overview Must be evaluated for Stability Program Inclusion Analytical Methodology and Process Validation Discusses the Need for Accurate and Precise Monitoring Techniques Why are the Development Validated Methods necessary? Speakers: Barry A. Friedman, Ph.D Consultant Cambrex Bio Sciences Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Process Validation for Pharmaceutical and Biologics CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Yahoo
13 hours ago
- Business
- Yahoo
FDA Process Validation for Pharmaceutical and Biologics Course (ONLINE EVENT: June 11-12, 2025)
This FDA Process Validation Training session is an interactive online seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail. The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. Process Validation for Pharmaceutical and Biologics Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Process Validation for Pharmaceutical and Biologics" training has been added to offering. This FDA Process Validation Training session is an interactive online seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail. The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. The Process Validation Guidelines (January 2011) and the EU Annex 15: Requirement and Authentication (October 2015) outline the overall values and methods the two controlling bodies reflect suitable elements of process validation for the production of human and animal drugs and biological foodstuffs, including Active Pharmaceutical Ingredients (APIs). This directive aligns Process Validation activities with a product life cycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The life cycle concept, new to this Guidance, links creation and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. This supervision also cares for process development and novelty through sound science and risk management. The new Process Validation Guideline/Practice includes elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phases 2 and 3, and then commercial manufacturing. Some general questions asked by the users of FDA Process Validation Training Here are a few common questions that the trainees attending the FDA Process Validation Training must ask to upgrade their initial knowledge: How can one integrate these two different concepts (Phase-wise and stage-wise)? Where do they merge? Can they exist independently or can they complement each other to improve, figure, and deliver a product that neither alone could? To what extent, the users must use them? Does it follow along with Stage 3? Questions that exist include how one manages special situations including viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests including DNA and host cell protein. The experts for FDA Process Validation Training will address these questions in Stage 2 as presented here. It will include the utilization of Procedure Validation and Phase 1, 2, and 3, where their Guidance mixture and where remain distinct. In particular, Stage 3. Important: The seminar insists that the trainees attending the FDA Process Validation Training plan to bring a multidisciplinary cluster from your Establishment to get the most from this very important seminar. Objectives of Learning for FDA Process Validation Training: Why are these FDA Guidance/EU Guidelines for Industry-Process Validation so significant to the pharmacological and ergonomics industry? Where does the Process Validation commence? How does Stage 1 integrate with Phase 1? What FDA sections are composed and omitted within the "NEW" Process Validation? What are the Three Stages and Where Do They Apply within the NEW Process Validation? The Authentication approaches are included within this Guidance document. The Constitutional and Supervisory Requirements for Procedure Endorsement. An Outline to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation. The Phase 1 Untried Drug Requirements -- What is and What is NOT Required? General Considerations for Process Validation - Stage 2 Process Qualification. Regulatory Strategies for Phases 2 and 3 and their Incorporation within Stages 1 and 2. General Considerations for Process Validation - Stage 3 Continued Process Verification. An Appraisal of EU Annex 15 and its Comparison to FDA's Process Validation Direction. Who Should Attend: Quality Control Project Management Quality Assurance Product Development Regulatory Compliance Product Development Industrial and Amenities specialists who need to grow and participate in developing understanding regarding the issues surrounding Method Endorsement. Key Topics Covered: Day 1 Overview, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry What is included in the "New" Process Validation (PV) Guidance? The Constitutional and Supervisory Requirements for "PV" Interaction of the Three Stages with Procedure Validation General Considerations for 'PV" - Stage 1 Stage 2 - Phase 1. History and Controlling Basis Authentication Methods, cGMPs in Scientific Supply Manufacture, What's Included within Phase 1, Stage 2 A Review of Industrial Deliberations Special Industrial Situations within Phase 1 Multi-Product Amenities and their Organization Management of Organic and Biotechnology Amenities Management of Sterile Products/Aseptically Produced Products The Necessities of Phase 1 Investigational Medication Necessities How does One Understand and Utilize Them? Regulatory Strategies for Phases 2 and 3 and their Incorporation within Stages 1 and 2 Operation of Procedure Design to Regulate its Duplicability Competences Organization of Amenities, Apparatus, and Values Requirement Day 2 General Deliberations for Procedure Authentication - Stage 2 Process Qualifications Requirement of Values and Gear Expansion of Ecological or Conservational Monitoring Development of Amenities Project Water Systems Development Special Deliberations for Procedure Authentication - Stage 2 Appraisal of Special Study Protocols Studying the Special Requirements of Phase 2/3 Stage 2 Overall Considerations for Process Validation - Stage 3 Sustained Process Corroboration Promising Continued Process Confirmation Remains in Control Use of Cautionary Letters as Instances A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance A Demonstration of Similarity Between the Two Simultaneous Issue of Process Presentation Qualification (PPQ) Batches Rationalizes Why it Requires being Accompanied by a Systematic Critical Overview Must be evaluated for Stability Program Inclusion Analytical Methodology and Process Validation Discusses the Need for Accurate and Precise Monitoring Techniques Why are the Development Validated Methods necessary? Speakers: Barry A. Friedman, Ph.D Consultant Cambrex Bio Sciences Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Process Validation for Pharmaceutical and Biologics CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Standard
a day ago
- Entertainment
- Business Standard
Hong Kong's Brimming Culture Beckons Tourists To Delve Into Art, Carnival & Dance
NewsVoir Hong Kong, June 3: For culturally inclined travellers, Hong Kong provides plenty of opportunities to delve into the history and seek space in a unique cultural blend of old and new. So, don't limit your Hong Kong itinerary to just sightseeing, shopping, and street food hopping. There's certainly a lot more that it offers. From May 31-July 1, 2025, Hong Kong's Intangible Cultural Heritage (ICH) Office will host the inaugural 'Hong Kong ICH Month'. A month of carnivals, fun days, field trips, workshops, and seminar talks, which will be part of the 'ICH Around Town'. A time to immerse yourself in the city's rich cultural heritage, one activity at a time. Over 80 performances and 60 interactive booths during the festival will enthral crowds. Be it a tour in six handpicked districts or the "Genesis and Spirit: Intangible Cultural Heritage Exhibition on Jiangxi's Ganzhou Hakka Culture, there is so much to do and see. In line with the Chinese Culture Promotion Series, the ICH promotes Chinese history through its many programmes giving tourists and the public the chance to learn about the intriguing Chinese culture. The buzzing city of Hong Kong beckons you to wear your dancing shoes, your most festive attire and be part of the city's year-round vibrant festivities. There are world-class events and even seasonal celebrations in the mix. So, there's always something happening day in and day out in Hong Kong. Among the many unmissable events is the Sun Life Hong Kong International Dragon Boat Races happening from 7-8 June, 2025. Watch Victoria Harbour mystically transform into a space of cheer and celebrations as the adrenaline-fueled races return to the Tsim Sha Tsui East Promenade. For carnival goers, the Brazil Meets Hong Kong, from June 20 to 29, 2025, held at AIA Vitality Park in Central, celebrates Brazilian culture with much pomp and glory. Expect a 10-day celebration of the South American nation featuring samba, reggae and other activities. The first-ever Brazilian carnival in Hong Kong may soon become the city's annual event, blending the carnival fever with the city's multicultural set-up. Head over to Discover Hong Kong's calendar of cultural events, which you must bookmark to find so many options. But you shouldn't miss: Canton Modern: Art and Visual Culture, 1900s-1970s, from 28 June-5 Oct, 2025, a 200-works exhibition depicting the Cantonese art and visual culture; Happy Wednesday- Music Festival, from 4 June-16 July, 2025, where you can groove to the best beats from across the globe along with global bites; Dance x Drama 'Dance-to-know MULAN', from May 16-July 27, 2025, a dance drama of Chinese ethnic performances across dynasties. Hong Kong basks in its multicultural identity. It prides itself on being a destination where modern city life is embraced with the same fervour as ancient traditions are respected. The city offers a cultural landscape that is a melting pot of Cantonese customs, British colonial influences, and mainland Chinese elements. With the iconic dragon boat race, Intangible Cultural Heritage (ICH), the Brazilian Carnival and a slew of art exhibitions and dance dramas, Hong Kong is a cultural haven that welcomes tourists from all over the world. The events highlight the culture of the land through the glocal lens. These are unmissable and there is truly something for every traveller. Make your travel plans now! Curly Tales is India's leading food, travel and lifestyle platform founded by Kamiya Jani in 2016 after her decade-long experience as a finance, sports and lifestyle journalist and TV anchor. Curly Tales is a platform that offers content to inspire and inform viewers with a focus on celebrating food, travel and unique experiences across India and the globe. (ADVERTORIAL DISCLAIMER: The above press release has been provided by NewsVoir. ANI will not be responsible in any way for the content of the same)
Fashion Value Chain
a day ago
- Entertainment
- Fashion Value Chain
Hong Kong's Brimming Culture Beckons Tourists To Delve Into Art, Carnival & Dance
Hong Kong For culturally inclined travellers, Hong Kong provides plenty of opportunities to delve into the history and seek space in a unique cultural blend of old and new. So, don't limit your Hong Kong itinerary to just sightseeing, shopping, and street food hopping. There's certainly a lot more that it offers. From May 31-July 1, 2025, Hong Kong's Intangible Cultural Heritage (ICH) Office will host the inaugural 'Hong Kong ICH Month'. Hong Kong's Intangible Cultural Heritage (ICH) Office will host the inaugural 'Hong Kong ICH Month' A month of carnivals, fun days, field trips, workshops, and seminar talks, which will be part of the 'ICH Around Town'. A time to immerse yourself in the city's rich cultural heritage, one activity at a time. Over 80 performances and 60 interactive booths during the festival will enthral crowds. Be it a tour in six handpicked districts or the 'Genesis and Spirit: Intangible Cultural Heritage Exhibition on Jiangxi's Ganzhou Hakka Culture, there is so much to do and see. In line with the Chinese Culture Promotion Series, the ICH promotes Chinese history through its many programmes giving tourists and the public the chance to learn about the intriguing Chinese culture. The buzzing city of Hong Kong beckons you to wear your dancing shoes, your most festive attire and be part of the city's year-round vibrant festivities. There are world-class events and even seasonal celebrations in the mix. So, there's always something happening day in and day out in Hong Kong. Among the many unmissable events is the Sun Life Hong Kong International Dragon Boat Races happening from 7-8 June, 2025. Watch Victoria Harbour mystically transform into a space of cheer and celebrations as the adrenaline-fueled races return to the Tsim Sha Tsui East Promenade. For carnival goers, the Brazil Meets Hong Kong, from June 20 to 29, 2025, held at AIA Vitality Park in Central, celebrates Brazilian culture with much pomp and glory. Expect a 10-day celebration of the South American nation featuring samba, reggae and other activities. The first-ever Brazilian carnival in Hong Kong may soon become the city's annual event, blending the carnival fever with the city's multicultural set-up. Head over to Discover Hong Kongs calendar of cultural events, which you must bookmark to find so many options. But you shouldn't miss: Canton Modern: Art and Visual Culture, 1900s-1970s, from 28 June-5 Oct, 2025, a 200-works exhibition depicting the Cantonese art and visual culture; Happy Wednesday- Music Festival, from 4 June-16 July, 2025, where you can groove to the best beats from across the globe along with global bites; Dance x Drama 'Dance-to-know MULAN', from May 16-July 27, 2025, a dance drama of Chinese ethnic performances across dynasties. Hong Kong basks in its multicultural identity. It prides itself on being a destination where modern city life is embraced with the same fervour as ancient traditions are respected. The city offers a cultural landscape that is a melting pot of Cantonese customs, British colonial influences, and mainland Chinese elements. With the iconic dragon boat race, Intangible Cultural Heritage (ICH), the Brazilian Carnival and a slew of art exhibitions and dance dramas, Hong Kong is a cultural haven that welcomes tourists from all over the world. The events highlight the culture of the land through the glocal lens. These are unmissable and there is truly something for every traveller. Make your travel plans now! About Curly Tales Curly Tales is India's leading food, travel and lifestyle platform founded by Kamiya Jani in 2016 after her decade-long experience as a finance, sports and lifestyle journalist and TV anchor. Curly Tales is a platform that offers content to inspire and inform viewers with a focus on celebrating food, travel and unique experiences across India and the globe.
