Aloka Srinivasan is seeking a leadership position in regulatory affairs. She has over 15 years of experience at the FDA and in the pharmaceutical industry evaluating drug applications and submissions. She has extensive experience reviewing various application types, including ANDAs, NDAs, INDs, and DMFs, across many therapeutic areas. She also has experience establishing new divisions and programs at the FDA and writing numerous guidance documents.
Regulatory compliance is important for the pharmaceutical industry. It refers to adhering to both legal requirements and internal policies. Ensuring compliant and ethical business practices is key. Compliance aims to solve legal issues, ensure safety, and increase demand. It involves oversight from regulatory bodies, industries, and consumers. Pharmaceutical companies must establish procedures, control materials, perform tests, and share data with inspectors to maintain compliance. Following guidelines and rules can help compliance work effectively.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
Sonia Haley has over 30 years of experience in regulatory affairs and clinical research. She has worked with the FDA on numerous INDs, NDAs, and clinical trials across multiple therapeutic areas including cell therapies, biologics, and pharmaceutical drugs. Her experience includes developing regulatory strategies, compiling submissions, communicating with the FDA, and ensuring compliance. She is a licensed pharmacist and member of several professional organizations.
This document discusses regulatory affairs documentation including Master Formula Records (MFRs) and Drug Master Files (DMFs). It explains that MFRs provide complete product descriptions to ensure batch-to-batch uniformity, while DMFs confidentially provide manufacturing and quality control information to regulatory agencies. Key elements of these documents are outlined, such as their structure, components, procedures for preparation and maintenance, and importance in obtaining marketing authorization and maintaining compliance.
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
Oral Drug Formulation Innovations 2014Simon Curtis
The Oral Drug Formulation Innovations Summit will examine and showcase the industry's latest formulation and delivery technologies for enhancing solubility and maximizing bioavailability. Leading global formulation experts in both industry and academia will share unique strategies on how to effectively develop poorly soluble drugs into scientifically unique, compliant, patient-centric formulations. Additionally, innovative strategies to significantly reduce product development timelines will be shared, and the latest regulatory requirements will be discussed.
Laboratory and Pharmaceutical Quality Assurance ExpertMathias Atelefack
- The document provides a summary of a laboratory scientist's qualifications and experience over 20 years working in FDA-regulated laboratories in the pharmaceutical and biotechnology industries.
- It outlines his extensive experience overseeing quality assurance/quality control of pharmaceutical manufacturing processes and products, including tablets, capsules, liquids and medical devices.
- Recent roles included providing quality oversight for analytical laboratory operations at a pharmaceutical company, conducting data integrity audits at another pharmaceutical company, and consulting for various pharmaceutical manufacturers on quality assurance issues.
This document discusses Quality by Design (QbD) in API manufacturing. It begins by quoting Joseph M. Juran that quality must be built in by design, not tested in. It then defines QbD as a systematic approach that emphasizes product and process understanding and control based on science and risk management. The document outlines some of the key aspects of QbD like design space, quality risk management, and using tools like design of experiments. It compares the traditional and QbD approaches and discusses some of the pros and cons of QbD.
Regulatory compliance is important for the pharmaceutical industry. It refers to adhering to both legal requirements and internal policies. Ensuring compliant and ethical business practices is key. Compliance aims to solve legal issues, ensure safety, and increase demand. It involves oversight from regulatory bodies, industries, and consumers. Pharmaceutical companies must establish procedures, control materials, perform tests, and share data with inspectors to maintain compliance. Following guidelines and rules can help compliance work effectively.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
Sonia Haley has over 30 years of experience in regulatory affairs and clinical research. She has worked with the FDA on numerous INDs, NDAs, and clinical trials across multiple therapeutic areas including cell therapies, biologics, and pharmaceutical drugs. Her experience includes developing regulatory strategies, compiling submissions, communicating with the FDA, and ensuring compliance. She is a licensed pharmacist and member of several professional organizations.
This document discusses regulatory affairs documentation including Master Formula Records (MFRs) and Drug Master Files (DMFs). It explains that MFRs provide complete product descriptions to ensure batch-to-batch uniformity, while DMFs confidentially provide manufacturing and quality control information to regulatory agencies. Key elements of these documents are outlined, such as their structure, components, procedures for preparation and maintenance, and importance in obtaining marketing authorization and maintaining compliance.
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
Oral Drug Formulation Innovations 2014Simon Curtis
The Oral Drug Formulation Innovations Summit will examine and showcase the industry's latest formulation and delivery technologies for enhancing solubility and maximizing bioavailability. Leading global formulation experts in both industry and academia will share unique strategies on how to effectively develop poorly soluble drugs into scientifically unique, compliant, patient-centric formulations. Additionally, innovative strategies to significantly reduce product development timelines will be shared, and the latest regulatory requirements will be discussed.
Laboratory and Pharmaceutical Quality Assurance ExpertMathias Atelefack
- The document provides a summary of a laboratory scientist's qualifications and experience over 20 years working in FDA-regulated laboratories in the pharmaceutical and biotechnology industries.
- It outlines his extensive experience overseeing quality assurance/quality control of pharmaceutical manufacturing processes and products, including tablets, capsules, liquids and medical devices.
- Recent roles included providing quality oversight for analytical laboratory operations at a pharmaceutical company, conducting data integrity audits at another pharmaceutical company, and consulting for various pharmaceutical manufacturers on quality assurance issues.
This document discusses Quality by Design (QbD) in API manufacturing. It begins by quoting Joseph M. Juran that quality must be built in by design, not tested in. It then defines QbD as a systematic approach that emphasizes product and process understanding and control based on science and risk management. The document outlines some of the key aspects of QbD like design space, quality risk management, and using tools like design of experiments. It compares the traditional and QbD approaches and discusses some of the pros and cons of QbD.
Sravan Bandi is a regulatory affairs professional with over 4 years of experience in US FDA and Brazil ANVISA regulations. He has a Master's degree in Pharmacy and is currently working as a Regulatory Affairs Research Associate IV at Aurobindo Pharma Limited. His responsibilities include ANDA compilation and submissions, responding to queries, and preparing post-approval documents for the US, Brazil, China, and other markets. He has strong technical skills in dossier preparation and a thorough knowledge of pharmaceutical development documentation requirements.
This document discusses the concept of quality by design (QbD) in pharmaceutical development and manufacturing. It provides details on key elements of QbD including defining quality target product profiles, identifying critical quality attributes, understanding relationships between raw materials/process parameters and critical quality attributes, developing a design space, implementing a control strategy, and continually improving processes and products. The document compares traditional quality by testing approaches to QbD and outlines benefits of QbD such as increased flexibility, reduced costs, improved quality and predictability, and enabling real-time product release.
Kirti Choksi has over 20 years of experience in quality assurance, regulatory, and compliance roles in the pharmaceutical and biotechnology industries. She has worked for companies such as Pfizer, Johnson & Johnson, and EUSA Pharma, where she managed quality reviews, audits, and ensured compliance with FDA regulations. Choksi's experience includes developing strategies, policies and procedures, as well as authoring documents like annual drug product review reports. She has expertise in areas such as GMP, GCP, clinical trials, and regulatory submissions to bodies like the FDA and EMA.
Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
NABL is the National Accreditation Board for Testing and Calibration Laboratories in India. It provides accreditation to laboratories, medical testing facilities, proficiency testing providers, and reference material producers to formally recognize their technical competence. Accreditation has several benefits, including increased confidence in test and calibration reports, potential increased business, and acceptance in domestic and international markets. NABL currently provides accreditation in various fields including testing, calibration, medical laboratories, proficiency testing, and reference material production.
An introduction to the Linked Structured Product Label (LinkedSPL) resource for the W3C Health Care and Life Sciences Linking Open Drug Data task force. LinkeSPLs (purl.org/net/nlprepository/linkedSPLs) publishes selected sections of FDA-approved drug package inserts from DailyMed for use by NLP and Semantic Web researchers. Currently, only data from the product labels of prescription drugs is provided. This site's SPL data is updated weekly and all SPLs retain DailyMed versioning data so that researchers can record the provenance of the text and sections they work with. LinkedSPLs is provided as a service as part of the Drug Interaction Knowledge Base (DIKB) project
Narender Adepu is seeking a challenging position in quality with over 14 years of experience in the pharmaceutical industry. He holds an M.Sc. in Chemistry and has worked in quality control roles at various pharmaceutical companies. His responsibilities have included ensuring compliance with ICH, USFDA, and EU guidelines; method validations; stability studies; and handling audits. He is proficient in various laboratory software and analytical instruments and seeks to advance his career as a quality auditor.
Current issues and challenges in demonstrating QbD Korea 1 December 2014Ajaz Hussain
2014 Ministry of Food and Drug Safety (MFDS) International Workshop: Quality by Design (QbD) Implementation and Regulatory Challenges in theNew Pharmaceutical Quality ParadigmDecember 1 -2, 2014, Grand Hilton Hotel, Seoul, Korea.
Legitimate pharmaceutical community has practiced QbD for decades; however in ways that vary undesirably.
Demonstration of QbD is multifaceted.
There are serious consequences …in ways that can vary undesirably…
The consequence of “Cheating by Design” are almost always catastrophic.
Perhaps we need to view QbD applications/submissions as an additional layer of protection; to gauge the Culture of Quality.
Legitimate efficiency – is a key business driver, good for the patients, and the society overall.
Proposed ICH Q12: Regulatory Dossier - “regulatory commitments”.
Pharmaceutical Quality System aspects (ICH Q10) – risk and knowledge management system.
Post-Approval Change Management Plans and Protocols.
A reminder of the approach utilized for FDA’s PAT Guidance, Comparability Protocol and Team Approach.
Must focus on integrated implementation.
Team-building and training for Review, Compliance & Inspection functions.
Recognize that QbD Applications/submissions serve as an additional layer of protection; to gauge the Culture of Quality.
This document provides an introduction to Quality by Design (QBD) in pharmaceutical development and manufacturing. It discusses the evolution of quality approaches from chance to design. Key aspects of QBD covered include critical quality attributes (CQAs), critical material attributes (CMAs), critical process parameters (CPPs), risk assessment tools, and the role of statistics. The document presents examples of how to apply QBD concepts like quality target product profiles (QTPPs), Kano modeling, quality function deployment (QFD), and design of experiments (DoE) to identify and control elements critical to ensuring product quality.
The document is a curriculum vitae for Santanu Roy that outlines his career experience and qualifications. Some key points:
- Santanu has over 10 years of experience in regulatory affairs and quality assurance roles for pharmaceutical companies in India.
- His experience includes preparing regulatory submissions for markets like the US, Asia, Africa and preparing responses to deficiencies.
- Currently he works as manager of regulatory affairs at Glenmark Pharmaceuticals where he is responsible for CMC strategies and submissions.
This document discusses documentation practices in the pharmaceutical industry. It defines documentation and provides examples of common types of documentation like standard operating procedures, batch records, and specifications. The document outlines good documentation practices like having approval, clarity, and regular review. It discusses the importance of documentation for quality assurance and regulatory compliance. Documentation provides instructions for personnel and information for audits and investigations. The summary is the document discusses documentation practices in the pharmaceutical industry, defines documentation, outlines good practices like approval and review, and explains the importance for quality assurance and regulatory compliance.
Tanvir Mahmud has over 15 years of experience in project management and quality assurance roles in the pharmaceutical industry. He has a proven track record of managing cross-functional teams and projects at companies such as Biogen, Vertex Pharmaceuticals, and Boston Scientific. His core competencies include client relationship management, project management, employee coaching and training, and risk assessment. He holds certifications in Neuro Linguistic Programming and hypnotherapy.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
Program - 3rd Annual Drug Delivery and Formulation Summit 2013, San DiegoMark Blendheim
This document provides an agenda for a pharmaceutical development program taking place from April 30th to May 1st 2013 in San Diego, USA. The agenda includes:
- Welcome addresses and presentations on overcoming the patent cliff and improving clinical trial timelines on day 1
- Interactive workshops on oral drug delivery techniques and first-in-human formulation strategies
- Presentations on academic-government partnerships in nanotechnology and biologics development
- Panel discussion on improving development relationships and reducing costs and risk
- Additional presentations and workshops on topics including biologics modeling and simulation, enhancing solubility through micronization, and process validation.
Pharmaceutical Quality by Design (QBD) is a concept introduced by the International Conference on Harmonization (ICH) Q8 guideline, as a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management.
The basic concept of QBD is “The Quality cannot be tested into the product, but it should be built into it.”
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
6-3-2016 Regulatory Affairs entry level resume_Bum KimBum Kim
Bum Kim is seeking a career in regulatory affairs in the pharmaceutical/biotech industry. He has a M.S. in Regulatory Affairs and extensive experience in various regulatory roles, including technical writing, auditing, clinical research monitoring and compliance. His background includes research experience in drug discovery and development. He is proficient in FDA and international regulations regarding drugs, biologics and medical devices.
HAZA CONSEJEROS TÉCNICOS es una empresa formada por profesionales multidisciplinares que ofrecen servicios técnicos de alto valor añadido a empresas. Sus objetivos son facilitar servicios técnicos a empresas, crear redes innovadoras, y promover el conocimiento compartido en sistemas de gestión, agroecología, y otros servicios técnicos.
Sravan Bandi is a regulatory affairs professional with over 4 years of experience in US FDA and Brazil ANVISA regulations. He has a Master's degree in Pharmacy and is currently working as a Regulatory Affairs Research Associate IV at Aurobindo Pharma Limited. His responsibilities include ANDA compilation and submissions, responding to queries, and preparing post-approval documents for the US, Brazil, China, and other markets. He has strong technical skills in dossier preparation and a thorough knowledge of pharmaceutical development documentation requirements.
This document discusses the concept of quality by design (QbD) in pharmaceutical development and manufacturing. It provides details on key elements of QbD including defining quality target product profiles, identifying critical quality attributes, understanding relationships between raw materials/process parameters and critical quality attributes, developing a design space, implementing a control strategy, and continually improving processes and products. The document compares traditional quality by testing approaches to QbD and outlines benefits of QbD such as increased flexibility, reduced costs, improved quality and predictability, and enabling real-time product release.
Kirti Choksi has over 20 years of experience in quality assurance, regulatory, and compliance roles in the pharmaceutical and biotechnology industries. She has worked for companies such as Pfizer, Johnson & Johnson, and EUSA Pharma, where she managed quality reviews, audits, and ensured compliance with FDA regulations. Choksi's experience includes developing strategies, policies and procedures, as well as authoring documents like annual drug product review reports. She has expertise in areas such as GMP, GCP, clinical trials, and regulatory submissions to bodies like the FDA and EMA.
Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
NABL is the National Accreditation Board for Testing and Calibration Laboratories in India. It provides accreditation to laboratories, medical testing facilities, proficiency testing providers, and reference material producers to formally recognize their technical competence. Accreditation has several benefits, including increased confidence in test and calibration reports, potential increased business, and acceptance in domestic and international markets. NABL currently provides accreditation in various fields including testing, calibration, medical laboratories, proficiency testing, and reference material production.
An introduction to the Linked Structured Product Label (LinkedSPL) resource for the W3C Health Care and Life Sciences Linking Open Drug Data task force. LinkeSPLs (purl.org/net/nlprepository/linkedSPLs) publishes selected sections of FDA-approved drug package inserts from DailyMed for use by NLP and Semantic Web researchers. Currently, only data from the product labels of prescription drugs is provided. This site's SPL data is updated weekly and all SPLs retain DailyMed versioning data so that researchers can record the provenance of the text and sections they work with. LinkedSPLs is provided as a service as part of the Drug Interaction Knowledge Base (DIKB) project
Narender Adepu is seeking a challenging position in quality with over 14 years of experience in the pharmaceutical industry. He holds an M.Sc. in Chemistry and has worked in quality control roles at various pharmaceutical companies. His responsibilities have included ensuring compliance with ICH, USFDA, and EU guidelines; method validations; stability studies; and handling audits. He is proficient in various laboratory software and analytical instruments and seeks to advance his career as a quality auditor.
Current issues and challenges in demonstrating QbD Korea 1 December 2014Ajaz Hussain
2014 Ministry of Food and Drug Safety (MFDS) International Workshop: Quality by Design (QbD) Implementation and Regulatory Challenges in theNew Pharmaceutical Quality ParadigmDecember 1 -2, 2014, Grand Hilton Hotel, Seoul, Korea.
Legitimate pharmaceutical community has practiced QbD for decades; however in ways that vary undesirably.
Demonstration of QbD is multifaceted.
There are serious consequences …in ways that can vary undesirably…
The consequence of “Cheating by Design” are almost always catastrophic.
Perhaps we need to view QbD applications/submissions as an additional layer of protection; to gauge the Culture of Quality.
Legitimate efficiency – is a key business driver, good for the patients, and the society overall.
Proposed ICH Q12: Regulatory Dossier - “regulatory commitments”.
Pharmaceutical Quality System aspects (ICH Q10) – risk and knowledge management system.
Post-Approval Change Management Plans and Protocols.
A reminder of the approach utilized for FDA’s PAT Guidance, Comparability Protocol and Team Approach.
Must focus on integrated implementation.
Team-building and training for Review, Compliance & Inspection functions.
Recognize that QbD Applications/submissions serve as an additional layer of protection; to gauge the Culture of Quality.
This document provides an introduction to Quality by Design (QBD) in pharmaceutical development and manufacturing. It discusses the evolution of quality approaches from chance to design. Key aspects of QBD covered include critical quality attributes (CQAs), critical material attributes (CMAs), critical process parameters (CPPs), risk assessment tools, and the role of statistics. The document presents examples of how to apply QBD concepts like quality target product profiles (QTPPs), Kano modeling, quality function deployment (QFD), and design of experiments (DoE) to identify and control elements critical to ensuring product quality.
The document is a curriculum vitae for Santanu Roy that outlines his career experience and qualifications. Some key points:
- Santanu has over 10 years of experience in regulatory affairs and quality assurance roles for pharmaceutical companies in India.
- His experience includes preparing regulatory submissions for markets like the US, Asia, Africa and preparing responses to deficiencies.
- Currently he works as manager of regulatory affairs at Glenmark Pharmaceuticals where he is responsible for CMC strategies and submissions.
This document discusses documentation practices in the pharmaceutical industry. It defines documentation and provides examples of common types of documentation like standard operating procedures, batch records, and specifications. The document outlines good documentation practices like having approval, clarity, and regular review. It discusses the importance of documentation for quality assurance and regulatory compliance. Documentation provides instructions for personnel and information for audits and investigations. The summary is the document discusses documentation practices in the pharmaceutical industry, defines documentation, outlines good practices like approval and review, and explains the importance for quality assurance and regulatory compliance.
Tanvir Mahmud has over 15 years of experience in project management and quality assurance roles in the pharmaceutical industry. He has a proven track record of managing cross-functional teams and projects at companies such as Biogen, Vertex Pharmaceuticals, and Boston Scientific. His core competencies include client relationship management, project management, employee coaching and training, and risk assessment. He holds certifications in Neuro Linguistic Programming and hypnotherapy.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
Program - 3rd Annual Drug Delivery and Formulation Summit 2013, San DiegoMark Blendheim
This document provides an agenda for a pharmaceutical development program taking place from April 30th to May 1st 2013 in San Diego, USA. The agenda includes:
- Welcome addresses and presentations on overcoming the patent cliff and improving clinical trial timelines on day 1
- Interactive workshops on oral drug delivery techniques and first-in-human formulation strategies
- Presentations on academic-government partnerships in nanotechnology and biologics development
- Panel discussion on improving development relationships and reducing costs and risk
- Additional presentations and workshops on topics including biologics modeling and simulation, enhancing solubility through micronization, and process validation.
Pharmaceutical Quality by Design (QBD) is a concept introduced by the International Conference on Harmonization (ICH) Q8 guideline, as a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management.
The basic concept of QBD is “The Quality cannot be tested into the product, but it should be built into it.”
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
6-3-2016 Regulatory Affairs entry level resume_Bum KimBum Kim
Bum Kim is seeking a career in regulatory affairs in the pharmaceutical/biotech industry. He has a M.S. in Regulatory Affairs and extensive experience in various regulatory roles, including technical writing, auditing, clinical research monitoring and compliance. His background includes research experience in drug discovery and development. He is proficient in FDA and international regulations regarding drugs, biologics and medical devices.
HAZA CONSEJEROS TÉCNICOS es una empresa formada por profesionales multidisciplinares que ofrecen servicios técnicos de alto valor añadido a empresas. Sus objetivos son facilitar servicios técnicos a empresas, crear redes innovadoras, y promover el conocimiento compartido en sistemas de gestión, agroecología, y otros servicios técnicos.
Este edicto notifica a los vecinos Medardo Valderrama Higuita y José Roso Muñoz Londoño sobre una solicitud de licencia de construcción presentada por Edgar de Jesús Aragón Rueda para un predio ubicado en la carrera 17 N°8-53 en Santa Fe de Antioquia. Los vecinos tienen 5 días hábiles para acercarse a la Secretaría de Planeación e Infraestructura municipal si tienen alguna objeción o solicitud relacionada con el trámite.
PragmaSoft es una empresa de consultoría en ingeniería de software que ofrece servicios integrales, productos y capacitación para implementar mejores prácticas de desarrollo de software. Sus consultores tienen más de 20 años de experiencia en áreas como implementación de arquitectura empresarial, automatización de procesos, adopción de metodologías ágiles y desarrollo de software. La empresa también brinda capacitación en estas áreas y vende hardware y electrónicos a través de comercio electrónico y canales minoristas.
Harness Mobility - Go Mobile On Oracle Appsbrijeshbharat
The document discusses how Oracle provides mobile apps that allow users to access Oracle applications from their smartphones. It describes several Oracle apps for tasks like sales forecasting, expense reporting, and asset maintenance. It explains that the apps retrieve secure data from Oracle Business Intelligence via SSL and can be used on smartphones like iPhone, Blackberry, Android and more. Mobile access to business information is becoming increasingly important for productivity and an essential business tool.
Este documento describe cómo usar un nivel láser para ajustar la alineación y configuración de varias partes de un avión de modelo, incluyendo la incidencia del motor, ala y estabilizador, la deflexión de los alerones y timón, y el aplomo del timón y estabilizador. El nivel láser proyecta una línea de luz que permite verificar con precisión que estas superficies estén alineadas correctamente según los ángulos deseados de forma sencilla y económica.
Homer Simpson es el cabeza de familia de Los Simpson. Sus grandes aficiones incluyen hacer locuras, comer dulces, y ver televisión por cable. Debido a estas características, Homer es considerado el personaje más divertido de la serie.
El documento presenta el currículum de Horacio Esponda Cal y Mayor, con más de 20 años de experiencia en administración de ventas, crédito, planeación estratégica y administración. Ha ocupado cargos directivos en empresas como Grupo GORSA, Semex y Cemex, donde se ha destacado por incrementar ventas, disminuir cartera vencida y mejorar la gestión del capital de trabajo.
The document discusses the lack of broadband internet access in rural areas of Germany. It notes that Deutsche Telekom has stopped deploying DSL infrastructure in rural regions, leaving many areas with only slow speeds between 6-16 Mbps. Wireless solutions have also not been widely accepted. Some communities have begun deploying their own fiber networks to address the lack of access. Examples mentioned include the towns of Alveslohe, Oerrel, Hamm, Lünen, Kamen, Schwerte, and Coburg. The document also discusses a partnership between Vodafone and a consulting group to deliver fiber internet to the rural town of Denklingen, with 2500 residents.
La Estrella ofrece una variedad de bebidas para disfrutar, localizada en la calle 20 de noviembre junto a Helados El Cometa. Aunque el servicio de entrega a domicilio es lento, demorando un mes, La Estrella busca mantener a los clientes contentos. El propietario es Pedro Contreras Hijo y el encargado es Saul Hernandes Rico.
Este documento discute el uso de la "instantaneidad" y la "transmisión eficaz de ideas" en la arquitectura. Argumenta que debido a la lentitud de la materialización de proyectos arquitectónicos, a veces se necesitan nuevas estrategias, como obras que transmitan un mensaje de manera rápida e instantánea. Analiza ejemplos actuales como "Recetas urbanas" de Santiago Cirugeda y "Post it cities", que utilizan diseños estratégicos y efímeros para comunicar ideas críticas de manera eficaz.
Este documento presenta las orientaciones generales para la enseñanza de la educación religiosa en el Distrito Capital de Bogotá. Explica que la educación religiosa se basa en un enfoque conceptual que tiene en cuenta la dimensión trascendente del ser humano y contribuye a la formación integral de los estudiantes. También justifica la enseñanza de la religión por su aporte a la persona, la escuela, la sociedad y la cultura. Luego, propone objetivos y contenidos curriculares para la educación religiosa, así como criter
Mujeres gallegas que inspiraron la literatura: guía de lecturaBibliotecadicoruna
Este documento presenta breves biografías de 13 mujeres gallegas que han inspirado obras literarias. Entre ellas se encuentran María Balteira, una bailarina del siglo XIII; Isabel Barreto de Castro, la primera mujer almirante en la historia de la navegación española; e Inés de Castro, amante y luego esposa del rey Pedro I de Portugal. El documento también resume las obras literarias inspiradas por cada una de estas importantes figuras femeninas de la historia y cultura gallegas.
Che forma sta prendendo il cambiamento? Report di quanto emerso ai tavoli del...RENA
Report delle discussioni emerse ai tavoli tematici del Festival delle Comunità del Cambiamento.
Bologna, 14 Giugno 2014
http://www.progetto-rena.it/festival/programma/
EGC Agri Capital is the first and only agriculture-focused venture capital company in Turkey. It aims to provide sustainable returns through investments in agriculture companies. It has subsidiaries operating dairy farms and sheep breeding operations. Tolina Organic Dairy Farm is EGC Agri Capital's only organic certified and EU approved dairy farm in Turkey.
Recuperación de conocimiento tradicional y organización productivaFAO
Presentación de Elissete Ramirez, Grupo de Hongueras Pjiekakjoo, sobre Recuperación de conocimiento tradicional y organización productiva, durante el Taller de intercambio de experiencias en Cadenas Cortas Agroalimentarias.
1) Regulatory affairs professionals play important roles in coordinating scientific efforts with regulatory needs throughout a product's lifecycle. They help companies reduce time to market and maximize resources.
2) Key responsibilities include evaluating marketing applications, issuing approvals, developing guidelines, inspecting sites, and monitoring drug safety.
3) In the pharmaceutical industry, regulatory affairs professionals develop regulatory strategies, prepare applications, maintain relationships with health authorities, and ensure compliance.
This document summarizes a presentation on shape knowledge to navigate future limitations in pharmaceutical quality and regulatory affairs. It discusses developing tools to modernize quality assessment and knowledge management throughout the drug product lifecycle. Critical quality attributes and corresponding mitigation strategies are discussed for APIs, drug substances, and finished drug products. The presentation also covers ensuring GMP compliance and addressing deficiencies or impurities that could affect drug quality or safety. Knowledge management is emphasized to research, understand, control, and mitigate potential issues.
The document discusses the FDA's Critical Path Initiative, which aims to improve the process of drug development and evaluation. It notes that the current drug development process is becoming a bottleneck. The initiative seeks to identify specific projects through a science-driven, shared effort between stakeholders to improve efficiency. The FDA must lead efforts to question assumptions that slow new product development and identify more efficient alternatives. The document also discusses two proposed projects - to create a "current state" process map to identify opportunities for improvement, and to develop a knowledge management system using ICH Q8 to ensure appropriate connectivity between all regulatory disciplines involved in drug development and review.
Regulatory affairs professionals play an important role in the pharmaceutical industry from research and development through product approval, manufacturing, and post-market surveillance. They are responsible for ensuring compliance with regulations from agencies like the FDA and interacting with regulatory bodies to obtain approvals for clinical trials and new products. Regulatory affairs personnel also provide guidance on regulatory requirements and strategies to accelerate development timelines. They help develop guidelines and perform inspections to issue certifications.
6 3-2016 regulatory affairs entry level resume bum kimBum Kim
I find it very difficult to get my first step in the door for my Regulatory Affairs Career, but I am sure that I will be a very successful Regulatory Affairs Professional once I can get started with my first job!!! Knocking on the opportunities right now!!!
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
1. Introduction to regulatory affairs (2).pptxMdJubair13
Regulatory affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development as well as after drug approval and marketing. Regulatory affairs professionals ensure that products contribute to public health by controlling safety and efficacy through compliance with regulations. They provide strategic and technical advice throughout development and registration of products with regulatory agencies. The scope of regulatory affairs includes pharmaceuticals, medical devices, diagnostics, biologics, and other health-related products.
Speid & Associates provides consultancy services to help speed new drugs to market. They have a team of expert consultants with experience in regulatory affairs, clinical development, drug development, and other areas. Their services include strategic planning, preparing regulatory submissions, conducting due diligence, assisting with clinical trials, and training company staff. They work with clients around the world to help achieve successful global drug registration.
This document provides an overview of a workshop on quality by design (QbD) for generic drugs. It discusses the following key points:
1. The workshop consists of 5 sessions covering topics like QbD overview, quality target product profiles, product and process design and understanding, control strategy, and generic drug user fees.
2. The FDA is implementing QbD for generic drugs to enhance knowledge sharing, reduce costs from poor quality, and improve consumer confidence in generics. Full implementation is targeted for January 2013.
3. For generic drug applications, the FDA will expect submissions to include a quality target product profile, identification of critical quality attributes and critical process parameters, and a control strategy. This represents
The document provides a summary of an individual's experience and qualifications. It outlines over 4 years of experience conducting secondary market research in the pharmaceutical industry, including therapeutic area analysis, clinical trials analysis, and report writing. Additional responsibilities included managing projects, training others, and presenting research findings to clients. The individual holds an M.Pharmacy degree and has published several research papers and reviews on topics related to pharmacology.
The document summarizes the review processes for new drug applications in the United States under 505(b)(1), 505(b)(2), and 505(j). It discusses the roles of the FDA and CDER and describes the types of applications, meetings, and fees involved in IND, NDA, and ANDA review processes. The review processes include application submission and review, communication of deficiencies, requests for additional information, inspections, and potential approval or refusal of applications.
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
This document provides information about an upcoming conference on abuse deterrent formulations. The two-day conference will be held on May 19-20, 2015 at the DoubleTree by Hilton in Silver Spring, MD. It will focus on strategies for developing opioid and non-opioid drugs with reduced abuse potential, including best practices for clinical trials, gaining FDA approval, and communicating claims. Speakers will include representatives from pharmaceutical companies and regulatory experts. Attendees will learn about formulation technologies, clinical study design, regulatory pathways, and policy issues regarding abuse deterrent drugs.
Hafiz Choudhury has over 10 years of experience in regulatory affairs across multiple therapeutic areas and geographies. He has worked as a regulatory affairs manager or consultant for several large pharmaceutical companies, managing submissions like CTAs, MAAs, variations, and renewals. Currently he works as a regulatory affairs manager at PAREXEL International, where he leads projects and coordinates regulatory submissions globally.
Similar to SRINIVASAN_AResume(2016) for Linked In (20)
1. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 1 of 8
Objective
A Ph.D. chemist seeking a challenging leadership position that will allow me to utilize my knowledge, scientific and
regulatory experience as a VP, Regulatory Affairs, Team Leader in Office of Generic Drugs in CDER/FDA,
Principal Consultant at Parexel International and Senior Scientist at National Cancer Institute,
Professional Summary
More than 15 years of experience in FDA and othergovernment agencies, evaluating the chemistry,
manufacturing, and control (CMC) sections of applications and performing scientific research
Experienced in the assessment, reviewing and writing of ANDAs and NDAs with a focus on 505(b)(2) NDAs,
IND), DMFs, and FDA briefing documents for diverse therapeutic classes of drugs
Worked with a broad range of dosage forms and drug products including anti-diabetics, anti-epileptics, anti-
Alzheimer’s, oncologic, topical antibiotics, NSAIDs, cardiovascular drugs, , PDE-5 Inhibitors, narcotic
analgesics,iron-carbohydrate products,to name a few
Instrumental in establishing a DMF review division in FDA to meet the GDUFA (generic drug user fee act)
related goals;
Pivotal role in writing of the Draft Guidance for Industry:Initial Completeness Assessments forType II API
DMFs Under GDUFA, which is currently being used by FDA to assess the “completeness” of Type II DMFs
under GDUFA and a QbR for Drug MasterFiles, including a companion document, which is soon to be adapted
by CDER for DMF review
Presented the initiative related to DMFs at several national and international industry forums as well as within
FDA
Actively participated in writing the QbR for ANDAs, presented the Office of Generic Drug’s Question based
Review (QbR), Quality by Design (QbD) initiative to the industry forums and international forums
Primary author of the fist draft of QbR for APIs, which is soon to be finalized for Type II DMFs as well as 3.2.S
section of NDA submissions
Well known for a series of articles regarding the common deficiencies in ANDAs, which have been translated
to many languages and have streamlined the review process within the agency and helped the industry,by
providing transparency and clarity regarding the agency’s rationale behind citing deficiencies
Member and FDA Liaison of Monograph Development Committee of USP for Cardiovascular Drugs 2005-
2010 and USP Excipient committee from 2010-2012.
Participated in working groups,committees, and preparation of guidance documents, including working with
the CDER Tiger Team to meet the GDUFA goals for CMC reviews in CDER/FDA.
Received special citation from CDER Office Director for leadership in implementing and developing innovative
DMF review systemin OGD
Research focus at National Cancer Institute on anti-cancer small molecules, that are potential nitric oxide
donors
Published many scientific and regulatory articles in peer reviewed journals
Work Experience
June 2016-Present Lupin Inc., Baltimore
Vice President, Regulatory Affairs
The position involves championing regulatory efforts for the generic and specialty business based on extensive
experience and in-depth knowledge of US regulatory requirements; possess working knowledge of submission of
2. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 2 of 8
biosimilars; working in a matrix organization on a multinational basis; designing and developing processes which
would ensure that every product meets federal regulatory requirements.
Responsibility involves the following:
Overview of all submissions, approvals, and maintenance including development of regulatory strategies
for high barrier generics and improved branded versions of approved molecules.
Communicate effectively within the organization and with internal/external customers regarding product
related activities.
Work very closely with the R&D to provide early guidance/support to ensure the completeness of filing and
facilitate the ease of review at the FDA.
A high level interaction with all key team leads of other departments to ensure the transparency of FDA
communications.
Extensive interaction with the OGD and New Drug Divisions of the FDA.
Lead and develop Regulatory Department direct reports.
Support with biosimilar filings
Supporting with products requiring clinical studies – NDA’s including 505b2 pathways, as well as
ANDA’s (ie, topical products).
June 2012 – June 2016 PAREXEL International
Principal Consultant
Provide strategic guidance to applicants in the area of regulatory and chemistry, manufacturing and controls for drug
products and drug substancesat all stages ofdevelopment and for all types of regulatory submissions, NDAs, INDs,
ANDAs, DMFs, including Quality-by-Design (QbD) submissions.
Supporting several 505(b)(2) NDAs and complex generic applications at US FDA
Act as thought leader in in various scientific and regulatory aspects related to drug development and
manufacturing.
Work in a high volume, fast paced environment at with changing deadlines and priorities
Collaborate in projects with diverse group of scientific experts and regulators
Provide advice and strategies for regulatory submissions with the goal of anticipating regulatory
challenges with an optimal business process that leverages PAREXEL’s multidisciplinary expertise.
Present on behalf of the industry in many national and international forums
November 2011-June 2012 Office of Generic Drugs, FDA
Team Leader/DMF Pilot Team
Responsible for establishing a new division within CDER for review of Type II Drug Masterfiles
Planning and establishing program goals and objectives for the future division, laying the outline of
workflow, staffing requirements etc.
Developed the matrices for the productivity of the division since this is the first time a Drug MasterFile
review division is being established at FDA
Establishing lines of communication between Office of Generic Drugs and other offices (ONDQA, CVM,
OBPM) who are also involved with DMFs
Writing Internal Quality Procedures (OPS equivalent of SOPs) for DMF review
3. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 3 of 8
Developing a training program for the new reviewers who may join the division in near future
Laying the groundwork for developing guidances and also documents related to Question Based Review of
Drug MasterFiles
Providing valuable input in improving the submissions of Drug Master Files as a member of the Drug
MasterFile Guidance group in Office of Pharmaceutical Sciences/FDA
Providing input as a team leader to the OGD Quality by Design initiative for the generic drugs
Writing the first draft for a Question Based Review (QbR) for APIs, which is currently being finalized and
will be adopted for generic as well as new drugs
Performing secondary and tertiary review of Drug MasterFiles
March 2008-November 2011 Office of Generic Drugs, FDA
Team Leader/Division III
Performing secondary reviews of abbreviated new drug applications
Responsible for establishing program goals and objectives for the team
Researching of ANDA and DMF related problems, consulting with other professionals both within and
outside the Division, and otherFederal Agencies as needed
Counseling and training team members, personally explaining critical and significant scientific concepts,
establishing processes,procedures,and guidelines
Addressing professionalgroups in the areas that affect the mission of the Office of Generic Drugs
Published and presented on several occasions regarding FDA perspective of the current state of Question
Based Review- Quality overall summary
Published a series of articles regarding the common deficiencies in ANDA to streamline the review process
within the agency and also help the industry by providing transparency and clarity regarding the agency’s
rationale behind citing deficiencies. This series has been translated to many languages.It is currently part
of the reviewer training manual of OGD. Also,GPhaA published a white paper on “Enhancing ANDA
Submissions: Working towards First Cycle Approval” in 2014, based on this series.
Presented to Generic Pharmaceutical Association (GPhA) on behalf of FDA.
One of the main Presented the Office of Generic Drug’s Quality by Design initiative at several Industry
forums and also international forums
Communicating with several offices within the FDA to make recommendations regarding drug shortage,
citizen petitions and also otherissues regarding pharmaceuticals
August 2003-March 2008 Office of Generic Drugs, FDA
SeniorReviewer in Division I and Division III
Responsible for review and evaluation of the Chemistry and Manufacturing Controls Section of Abbreviated
New Drug Applications and CMC Post ApprovalChanges
Participated and led internal meetings with an interdisciplinary review team to assess the safety and efficacy of
generic drugs
Presented in several national and international meetings
Participated in CDER activities such as seminars, courses,workshops on regulatory issues
Member of USP Expert Committee for Cardiovascular Drugs
Member of the Excipient Working Group at the Office of Generic Drugs, FDA
Member of the Question Based Review Working Group at the Office of Generic Drugs, FDA
Participated in writing a sample QbR-QOS for modified release tablets, which is posted in the FDA website
Reviewer of the first application submitted in QbR-QOS format
January 2001-June 2003 National Cancer Institute, Frederick, MD
4. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 4 of 8
SeniorStaff Scientist Advisor: Dr. Larry K. Keefer
Studying the metabolites formed by NO donor prodrugs in vitro on incubation with various isoforms of
cytochrome P450, with special interest in CYP3A4, 1A1 and CYP2E1
Designing and creating a dynamic website, with an extensive database ofnitric oxide donors made by our
group, the address of the site is http://home.ncifcrf.gov/lcc/nitricoxide/default.asp
December 1994-December 1998 National Cancer Institute, Frederick, MD
Intramural Research Fellow Advisor: Dr. Larry K. Keefer
Worked with a novel class of nitric oxide donors pro-drugs
Elucidated the photochemistry of a class of drugs designed for topical application
Provided analytical support for in vitro and in vivo studies of the fate of the nitric oxide donors
Successfully developed of a class of nitric oxide donors that are selectively activated in drug resistant tumors
Participated in designing a class of nitric oxide donors that may be possible treatment for sickle cell anemia
Modified various analytical methods of measuring the extent of nitric oxide released in vivo by nitric oxide
donors
June 1993-August 1994 University of Missouri, Columbia
Research Associate Fellow Advisor: Dr. Milton Feather
Did research in the field of carbohydrate chemistry. Developed a stereospecific total synthesis ofuniformly 14C
labeled l-ascorbic acid starting from uniformly 14C labeled d-glucose by modifying the method of Theander et
al.
May 1988-June 1993 University of Missouri, Columbia
Graduate Research Assistant Advisor: Dr. Richard N. Loeppky
Investigated the mechanism of activation of -hydroxynitrosamines, a potent class of animal carcinogens
Synthesized possible intermediates in the carcinogenic activity of these nitrosamines, and studied their reaction
with cellular reducing agents
Elucidated the mechanism of nitrosamine activation by identifying and carefully quantifying the products
formed in the reaction, trapping reactive intermediates in situ and performing a detailed kinetic study
Studied the mechanism of nitrosation of N-substituted aziridines, leading to the synthesis and identification of a
new class of four membered ring compounds,the dihydrodiazete-N-oxides
Education
The University of Missouri at Columbia
PhD in Chemistry, 1993
GPA: 4.0/4.0
Thesis: A study of putative intermediates involved in the activation of -oxidized nitrosamines and nitrosation of N-
substituted aziridines
Calcutta University, India
Masterof Science in Chemistry, 1987
Grade: First Class, Top 1% of the University
Presidency College, Calcutta University, India
Bachelor of Science in Chemistry, 1985
Grade: First Class with Honors, Top 1%
5. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 5 of 8
South Point High School, Calcutta, India
Graduated in 1981
Grade: First Division with Star, Top 1% of the State
Honors
Center Director’s Special Citation 2011,CDER/FDA (for leadership in implementing and developing the
innovative DMF Review System in OGD)
NIH Intramural Research Training Award, National Institutes of Health (grant award for research in the field
of nitric oxide)
Team Excellence Award, FDA (leadership for review of bolus application of generic Zonisamide in record
time)
Team Excellence Award, FDA (for review of first ANDA under OGD QbR initiative)
Team Excellence Award, FDA (for exceptional performance in preparing example Quality Overall Summaries
to guide sponsors and reviewers in implementation of OGD’s Question-based Review
Dedicated Volunteer Service Recognition, USP (for contribution as a member of USP Expert Committee for
Cardiovascular Drugs)
Patents
Saavedra, J. E., Keefer, L. K., Srinivasan, A., Rice, W. G., Ji, X., and Bogdan, C.: O2-Arylated or O2-
glycosylated 1-substituted diazen-1-ium-1,2-diolates and O2-substituted 1-[2-(carboxylato)pyrrolidin-1-
yl]diazen-1-ium-1,2-diolates. U.S. Patent 6,610,660, August 26, 2003.
Saavedra, J. E., Keefer, L. K., Srinivasan, A., Bogdan, C., Rice, W. G., and Ji, X.: O2-glycosylated 1-
substituted diazen-1-ium-1, 2-diolates. U.S. Patent 6,911,433, June 28, 2005 (continuation in part of U.S.
Patent 6,610,660).
Publications
Aloka Srinivasan, White Paper – Complex Generics: Maximizing FDA Approval ProcessAloka Srinivasan;
https://www.parexel.com/files/6714/3076/9385/ComplexGenerics_WPApril2015_final.pdf.
Aloka Srinivasan, Excipients in Generic Formulations, April1, 2014, Pharmaceutical Technology, Solid Dosage and
Excipients e-book, http://www.nxtbook.com/nxtbooks/ptebooks/pt_ebook_201404/index.php
A. Srinivasan; Q&A on GDUFA implementation with Aloka Srinivasan, Sep 2, 2012, Pharmaceutical Technology,
Volume 36, Issue 9, pp. 22-24
Debra; Torres de Holding, Claudia; Thomas, Lynta; Peterson, Kyle; Goodman, Gens; Saavedra, Joseph; Srinivasan,
Aloka; Davies, Keith; Keefer, Larry; Miranda, Katrina; HNO and NO release from a primary amine-based
diazeniumdiolate as a function of pH. Inorganic Chemistry. 2011, 50(8), pp. 3262-70
A. Srinivasan, R. Iser; Common Deficiencies in Abbreviated New Drug Applications Part 4: Control of the Drug
Product and Stability, Pharmaceutical Technology,April 2, 2011, 35 (4), pp. 62-68
A. Srinivasan, R. Iser and D. Gill; Common Deficiencies in Abbreviated New Drug Applications Part 3: Control of
the Drug Product and Stability, Pharmaceutical Technology,February 2, 2011, 35 (2), pp. 58-67
Aloka Srinivasan and Robert Iser, Devinder S. Gill; Common Deficiencies in Abbreviated New Drug Applications
6. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 6 of 8
Part 2: Description, Composition and Excipients, Pharmaceutical Technology,August 2, 2010, Volume 34 (8), 45-
51
Aloka Srinivasan and Robert Iser; Common Deficiencies in Abbreviated New Drug Applications
Part 1: Drug Substance, Pharmaceutical Technology,January 2, 2010, Volume 34 (1), pp. 50-59
Aloka Srinivasan and Robert Iser, FDA Office of Generic Drugs Question-Based Review Initiative:
An Update—Past,Present, and Next Steps, Journal of Validation Technology,Volume 15 (2), 2009, 2-5
Salmon, Debra, Torres de Holding, Claudia, Thomas, Lynta, Peterson,Kyle, Goodman, Gens, Saavedra, Joseph,
Srinivasan, Aloka, Davies, Keith, Keefer, Larry,Miranda, Katrina; HNO and NO release from a primary amine-
based diazeniumdiolate as a function of pH, Inorganic Chemistry, in press,Manuscript ID ic-2010-01736e.R1
X. Ji, A. Patel, R. Kalakathur, X. Hu, Y. Gu, J. E. Saavedra, G. S. Buzard, A. Srinivasan, L.K. Keefer, S. V. Singh;
Structure based design of anticancer drug, PABA/NO, Drug Design, Development and Therapy, 2008: 2, 123-130.
Larry K. Keefer, Keiko Inami, Raymond W. Nims, Aloka Srinivasan, et. al; V-PYRRO/NO, by human microsomal
cytochromes P450 Nitric Oxide: Biology and Chemistry, 2006, 14 (4), 309-15
Joseph E. Saavedra, Aloka Srinivasan, Larry K. Keefer, et. al: PABA/NO as an Anticancer Lead: Analogue
Synthesis,Structure Revision, Solution Chemistry, Reactivity toward Glutathione, and in vitro activity
J. Med. Chem.; 49 (3), 1157-64, 2006
Srinivasan, A., Kebede, N., Saavedra, J. E., Nikolaitchik, A. V., Brady, D. A., Yourd, E., Davies, K. M., Keefer, L.
K., and Toscano,J. P.: Chemistry of the diazeniumdiolates. 3. Photoreactivity. J. Am. Chem. Soc.123:5465-5472,
2001.
Saavedra, J. E., Srinivasan A., Bonifant, C. L., Chu, J., Shanklin, A. P., Flippen-Anderson, J. L., Rice, W. G.,
Turpin, J. A., Davies, K. M., and Keefer, L. K.: The secondary amine/nitric oxide complex ion R2N[N(O)NO]- as
nucleophile and leaving group in SNAr reactions. J. Org. Chem. 66: 3090-3098, 2001.
Southan,G. J., and Srinivasan, A.: Nitrogen oxides and hydroxyguanidines : Formation of donors of nitric and
nitrous oxides and possible relevance to nitrous oxide formation by nitric oxide synthase. Nitric Oxide:Biology and
Chem. 2: 270-286, 1998.
Hrabie, J. A., Srinivasan, A., George C., and Keefer, L. K.: Reaction of nitric oxide with the imine double bond of
certain Schiff bases. Tetrahedron Lett. 39: 5933-5936, 1998.
Southan,G. J., Srinivasan, A., George, C., Fales, H. M., and Keefer, L. K.: N-Nitrosated N-hydroxyguanidines are
nitric oxide-releasing diazeniumdiolates. Chem. Commun. 1191-1192, 1998.
Kelman, D. J., Christodoulou, D., Wink, D. A., Keefer, L. K., Srinivasan, A., and Dipple, A.: Relative
mutagenicities of gaseous nitrogen oxides in the supF gene of pSP189. Carcinogenesis 18: 1045-1048, 1997.
Loeppky, R. N., and Srinivasan, A.: Thiol oxidation by 1,2,3-oxadiazolinium ions, presumed carcinogens. Chem.
Res. Toxicol. 8: 817-820, 1995.
Loeppky, R. N., Erb, E., Srinivasan, A., and Yu, L.: Chemistry of putative intermediates in the bioactivation of -
oxidized nitrosamines. In Loeppky, R. N. and Michejda, C. J. (Eds.): Nitrosamines and Related N-Nitroso
7. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 7 of 8
Compounds,Chemistry and Biochemistry. Washington,D.C., American Chemical Society (ACS Symposium Series
No. 553), 1994, pp. 334-336.
Loeppky, R. N., Srinivasan, A., and Erb, E.: Putative proximate carcinogens derived from ethanolnitrosamines:
Chemical properties. In O'Neill, I. K. and Bartsch, H. (Eds.): Nitroso Compounds: Biological Mechanisms,
Exposures and Cancer Etiology. Lyon, International Agency for Research on Cancer (IARC Technical Report No.
11), 1991, pp. 42-43.
Loeppky, R. N., Qing F., Srinivasan, A., Glaser, R., Barnes, C. L., and Sharp, P. R.: Nitrosoaziridinium ion
isomerization: dihydrodiazete-N-oxides and azoxyalkenes from aziridine nitrosation. J. Am. Chem. Soc. 113: 2308-
2309, 1991.
Presentations
Srinivasan, Aloka: Proper CMC Submissions: Drug Substance:Defining Regulatory Starting Materials, GPhA CMC
Workshop,Bethesda, MD, June 9-10, 2015
Srinivasan, Aloka: Recent API-related FDA’s Question-based Review for APIs in Applications for new drugs and
generics, 17th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Vienna, Austria,
November 5–7, 2014
Srinivasan, Aloka: Proper CMC Submissions: Industry Perspective –API, GPhA CMC Workshop,Bethesda, MD,
June 3-4, 2014
Srinivasan, Aloka: Recent API-related Developments at FDA’s Office of Generic Drugs: GDUFA & Question-
Based Review, 15th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Budapest,Hungary,
November 07, 2012 – November 09, 2012
Srinivasan Aloka; Drug Substance Review, GPhA Fall Technical Conference, 2011, Bethesda, MD, October 3-5,
2011
Srinivasan Aloka and Iser, Robert: QbR Lessons Learned & Common Deficiencies in Abbreviated New Drug
Applications, GPhA Fall Technical Conference, 2010, Bethesda, MD, October 19-21, 2010
Srinivasan, Aloka, Iser, Robert and Lostrito, Richard: Signature Series: Deficiencies in New Drug Applicatoins,
Interphex Annual Conference, 2010, New York, NY, April 21, 2010
Srinivasan, Aloka and Iser, Robert, Key note address:FDA’s Quality-by- Design Program for Generic Drugs,
Pharmaceutical Tecnology’s 3rd AnnualConference, Philadelphia, PA, August 12, 2009
Srinivasan A: Review of the First ANDA with QbR-QoS: Lessons Learnt; Office of Generic Drugs, Rockville, MD,
July 12, 2006
Srinivasan A: Question-based Review for Quality Assessment of Generic Drugs; GPhA ANDA Basics Course,
Rockville, MD, May 25, 2006
Srinivasan A: Review of Amendments: Second Cycle and Beyond; Office of Generic Drugs Retreat, Gaithersberg,
MD, Sept 7, 2005
Srinivasan A: O2
-Substituted Diazeniumdiolates: A Novel Class of Nitric Oxide Donors; Office of Generic Drugs,
Rockville, MD, March 2004
8. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 8 of 8
Srinivasan, A: Chemistry of the Diazeniumdiolates. RHN[N(O)NO]- Ions as Progenitors of Both Nitroxyl and Nitric
Oxide: 228th National ACS Meeting, Philadelphia, PA, 2004
Srinivasan, A.: O2-Substituted diazeniumdiolates as nitric oxide donors.Invited talk, Glaxo-SmithKline, King Of
Prussia, PA, 2001
Srinivasan, A.: Diazeniumdiolates: A new class of nitric oxide donors.Invited talk, Parke Davis, Ann Arbor, MI,
1999
Srinivasan, A.: Chemistry of O2-substituted diazeniumdiolates. Invited talk, ABC Laboratories, Columbia, MO,
1999
Srinivasan, A., Saavedra, J. E., Booth, M., and Keefer, L. K.: O2-Aryl diazen-1-ium-1,2-diolates as nitric oxide
releasing agents. 213th National ACS Meeting, San Francisco, CA, 1997
Srinivasan, A., Saavedra, J. E., and Keefer, L. K.: Photolysis of O2-alkyl diazeniumdiolates: Are they photo
chemically triggered nitric oxide donors? 211th National ACS Meeting, New Orleans, LA, 1996
Srinivasan, A.: The chemistry of putative intermediates in the activation of beta-oxidized nitrosamines and
nitrosoaziridines. American Health Foundation,Valhalla, NY, 1993
Loeppky, R. N., Erb, E., Srinivasan, A., and Yu, L.: The chemistry of putative intermediates in the bioactivation of
beta-oxidized nitrosamines. 204th National ACS Meeting, Washington,DC, 1992
Srinivasan, A., Loeppky, R. N., Feng, Q., Glaser, R., Barnes, C. L., and Sharp, R. P.: Diazete-N-oxides and
azoxyalkenes from aziridine nitrosation. 203rd National ACS Meeting, Boston, MA, 1991
Srinivasan, A., Loeppky, R. N., Glaser, R., Barnes, C. L., and Sharp, P. R.: Aziridine nitrosation - a theoretical and
experimental study. Midwest Regional ACS Meeting, Manhattan,KS, 1990
Lahiri*, A. and Loeppky, R. N.: Thiol oxidation by alkoxydiazenium and 3-alkyl-1,2,3-oxidiazolinium ions.
Midwest Regional ACS Meeting, St. Louis, MO, 1989
*currently Srinivasan
Interviews
Backlog Backfire: FDA Sees Increase in Pending Generic Applications At Deadline, By Derrick Gingery, Pink
Sheet, Volume 74, No. 42, 2012
FDA's Dr. Srinivasan Discusses Question-based Reviews and QbD for Generic Drugs, By: Angie Drakulich, Jul 23,
2009, ePT--the Electronic Newsletter of Pharmaceutical Technology
References
Available upon request