This document provides information and advice about common interview questions for a regulatory affairs manager position. It lists 10 typical interview questions, such as "Why do you want this job?", "What challenges are you looking for?", and "What do you know about our company?". For each question, it provides a sample answer and tips on how to effectively respond. The document also includes additional links to online resources about interview preparation.
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
Presentation: eSubmissions in Australia - Part 2TGA Australia
The document discusses eSubmissions in Australia and provides guidance on:
1) Regional content requirements for Modules 2.3.R and 3.2.R.
2) Using node extensions to provide extra organizational information and grouping files.
3) Requirements for leaf titles, which are the display names for documents. Leaf titles should be short, precise and informative.
4) Acceptable file formats for each eCTD Module in Australia. PDF and XML are allowed for Module 1, while other Modules accept formats defined in ICH specifications.
“The regulatory landscape for biotech products in Ukraine”
Illustrates the current norms in place in Ukraine for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
The document discusses different types of variations to marketing authorizations for medicinal products in the EU. Variations are classified as minor (Type I) or major (Type II), with Type I divided into IA and IB categories based on the approval process required. The presentation covers definitions of variations, examples of different variation types, procedures for filing variations, and grouping of variations in a single application.
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
Presentation: eSubmissions in Australia - Part 2TGA Australia
The document discusses eSubmissions in Australia and provides guidance on:
1) Regional content requirements for Modules 2.3.R and 3.2.R.
2) Using node extensions to provide extra organizational information and grouping files.
3) Requirements for leaf titles, which are the display names for documents. Leaf titles should be short, precise and informative.
4) Acceptable file formats for each eCTD Module in Australia. PDF and XML are allowed for Module 1, while other Modules accept formats defined in ICH specifications.
“The regulatory landscape for biotech products in Ukraine”
Illustrates the current norms in place in Ukraine for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
The document discusses different types of variations to marketing authorizations for medicinal products in the EU. Variations are classified as minor (Type I) or major (Type II), with Type I divided into IA and IB categories based on the approval process required. The presentation covers definitions of variations, examples of different variation types, procedures for filing variations, and grouping of variations in a single application.
The document provides information about the European Medicines Agency (EMA) and marketing authorization procedures in the European Union. It describes the EMA's role in evaluating and authorizing medicines, its committees and membership. Four procedures for marketing authorization are outlined: centralized, national, mutual recognition and decentralized. The centralized procedure allows marketing across the EU, while national and decentralized are for individual countries. Mutual recognition relies on an existing national authorization. Timelines for evaluation are included.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
This document discusses lifecycle management strategies in the pharmaceutical industry. It begins by outlining the key drivers for effective lifecycle management, including the high costs of drug development and need to extend patent protection. Several lifecycle management strategies are then described, such as developing new indications, formulations, delivery methods, or integrating digital health tools. The document emphasizes that lifecycle management planning should begin early and consider factors such as clinical feasibility, regulatory pathways, intellectual property and commercial impacts when selecting strategies.
This document summarizes a presentation about US FDA regulation updates regarding electronic submissions. It discusses the FDA Electronic Submission Gateway (ESG), which provides a single entry point for securely submitting electronic documents. The ESG aims to automate processes, support electronic submissions in a standard format, and route submissions to the appropriate FDA center. The presentation also covers FDA initiatives for electronic submissions for drugs, biologics, devices, and other product types. It provides information on how to set up for electronic submissions using the ESG.
This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions.
It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information.
It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization.
Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
The document provides an overview of the Common Technical Document (CTD) format for organizing technical requirements for a generic drug product application to be submitted to regulatory authorities. It describes the CTD format, which includes Modules 1 through 5. Module 2 includes quality, non-clinical and clinical summaries. Module 3 contains information related to the drug substance and product quality. Module 5 contains clinical study reports, which for generic products would primarily include bioequivalence studies comparing the generic to an approved drug.
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
Registration procedure of drugs in european unionbdvfgbdhg
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
Type 1A and 1B variations are minor variations that have minimal or no impact on safety, efficacy, or quality. Type 1A variations are further divided into those requiring immediate notification ("IAIN") and those not requiring it ("IA"). Type II variations are major variations that may significantly impact safety, efficacy, or quality. Extensions apply to changes like new strengths or forms and require full evaluation. Variations are submitted based on classification and some can be grouped together in a single submission. The process involves regulatory submission and approval timelines that differ based on variation type. Marketing authorizations must be renewed every 5 years upon application by the holder to remain valid indefinitely.
Pharmaceutical Regulations in GCC countriesIman Ajami
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
The document compares the EU GMP and WHO GMP guidelines, identifying differences in requirements that impact costs. It finds that while the principles are largely the same, the WHO guidelines provide more detail and explanation. For example, on personnel the WHO specifies qualifications for key roles and describes hygiene practices, while premises are monitored more closely. Overall the WHO guidelines give more information to help ensure guidelines are properly interpreted and implemented.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
Clinical Trial Requirements U.S. vs. EU Similarities and DifferencesRETIRE
The document provides an overview of the key similarities and differences between clinical trial requirements in the United States and European Union. Some of the main differences include: in the US, IND approval is not required to begin a trial but the EU requires CTA approval; the US allows protocol waivers under certain conditions while the EU considers waivers a breach of GCP; and adverse event reporting timelines are generally shorter in the EU. Record keeping requirements for documents and investigational products also differ between the regions.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
The document discusses Thailand's drug control and registration system. It outlines the organization of the Drug Control Division within the Thai Food and Drug Administration and describes the drug licensing and registration processes. The drug registration system classifies drugs into new drugs, new generic drugs, and generic drugs and details the review process for new drug and new generic drug registration applications. It also discusses Thailand's safety monitoring program for new drugs and efforts to harmonize regulations with ASEAN standards.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
Top 10 regulatory affairs specialist interview questions and answersromeo23113
This document provides resources for preparing for a regulatory affairs specialist interview, including common interview questions, examples, and tips. It includes 10 sample interview questions for a regulatory affairs specialist role with detailed answers. Additionally, it lists many useful links to ebooks and articles on interview preparation, example questions, dressing for interviews, and more. The document aims to equip job applicants with comprehensive guidance for excelling at a regulatory affairs specialist interview.
Top 10 corporate services manager interview questions and answersrichfuma
This document provides resources for preparing for a corporate services manager interview, including common interview questions, examples of thank you letters, resume and cover letter samples. It lists several websites that offer free ebooks with additional interview questions and tips for how to effectively answer different types of questions. Specific questions covered include why the applicant wants the job, what challenges they are seeking, describing a typical work week, weaknesses, why the company should hire them, and questions for the interviewer. The document emphasizes researching the company and tailoring responses based on the position requirements.
The document provides information about the European Medicines Agency (EMA) and marketing authorization procedures in the European Union. It describes the EMA's role in evaluating and authorizing medicines, its committees and membership. Four procedures for marketing authorization are outlined: centralized, national, mutual recognition and decentralized. The centralized procedure allows marketing across the EU, while national and decentralized are for individual countries. Mutual recognition relies on an existing national authorization. Timelines for evaluation are included.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
This document discusses lifecycle management strategies in the pharmaceutical industry. It begins by outlining the key drivers for effective lifecycle management, including the high costs of drug development and need to extend patent protection. Several lifecycle management strategies are then described, such as developing new indications, formulations, delivery methods, or integrating digital health tools. The document emphasizes that lifecycle management planning should begin early and consider factors such as clinical feasibility, regulatory pathways, intellectual property and commercial impacts when selecting strategies.
This document summarizes a presentation about US FDA regulation updates regarding electronic submissions. It discusses the FDA Electronic Submission Gateway (ESG), which provides a single entry point for securely submitting electronic documents. The ESG aims to automate processes, support electronic submissions in a standard format, and route submissions to the appropriate FDA center. The presentation also covers FDA initiatives for electronic submissions for drugs, biologics, devices, and other product types. It provides information on how to set up for electronic submissions using the ESG.
This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions.
It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information.
It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization.
Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
The document provides an overview of the Common Technical Document (CTD) format for organizing technical requirements for a generic drug product application to be submitted to regulatory authorities. It describes the CTD format, which includes Modules 1 through 5. Module 2 includes quality, non-clinical and clinical summaries. Module 3 contains information related to the drug substance and product quality. Module 5 contains clinical study reports, which for generic products would primarily include bioequivalence studies comparing the generic to an approved drug.
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
Registration procedure of drugs in european unionbdvfgbdhg
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
Type 1A and 1B variations are minor variations that have minimal or no impact on safety, efficacy, or quality. Type 1A variations are further divided into those requiring immediate notification ("IAIN") and those not requiring it ("IA"). Type II variations are major variations that may significantly impact safety, efficacy, or quality. Extensions apply to changes like new strengths or forms and require full evaluation. Variations are submitted based on classification and some can be grouped together in a single submission. The process involves regulatory submission and approval timelines that differ based on variation type. Marketing authorizations must be renewed every 5 years upon application by the holder to remain valid indefinitely.
Pharmaceutical Regulations in GCC countriesIman Ajami
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
The document compares the EU GMP and WHO GMP guidelines, identifying differences in requirements that impact costs. It finds that while the principles are largely the same, the WHO guidelines provide more detail and explanation. For example, on personnel the WHO specifies qualifications for key roles and describes hygiene practices, while premises are monitored more closely. Overall the WHO guidelines give more information to help ensure guidelines are properly interpreted and implemented.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
Clinical Trial Requirements U.S. vs. EU Similarities and DifferencesRETIRE
The document provides an overview of the key similarities and differences between clinical trial requirements in the United States and European Union. Some of the main differences include: in the US, IND approval is not required to begin a trial but the EU requires CTA approval; the US allows protocol waivers under certain conditions while the EU considers waivers a breach of GCP; and adverse event reporting timelines are generally shorter in the EU. Record keeping requirements for documents and investigational products also differ between the regions.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
The document discusses Thailand's drug control and registration system. It outlines the organization of the Drug Control Division within the Thai Food and Drug Administration and describes the drug licensing and registration processes. The drug registration system classifies drugs into new drugs, new generic drugs, and generic drugs and details the review process for new drug and new generic drug registration applications. It also discusses Thailand's safety monitoring program for new drugs and efforts to harmonize regulations with ASEAN standards.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
Top 10 regulatory affairs specialist interview questions and answersromeo23113
This document provides resources for preparing for a regulatory affairs specialist interview, including common interview questions, examples, and tips. It includes 10 sample interview questions for a regulatory affairs specialist role with detailed answers. Additionally, it lists many useful links to ebooks and articles on interview preparation, example questions, dressing for interviews, and more. The document aims to equip job applicants with comprehensive guidance for excelling at a regulatory affairs specialist interview.
Top 10 corporate services manager interview questions and answersrichfuma
This document provides resources for preparing for a corporate services manager interview, including common interview questions, examples of thank you letters, resume and cover letter samples. It lists several websites that offer free ebooks with additional interview questions and tips for how to effectively answer different types of questions. Specific questions covered include why the applicant wants the job, what challenges they are seeking, describing a typical work week, weaknesses, why the company should hire them, and questions for the interviewer. The document emphasizes researching the company and tailoring responses based on the position requirements.
Top 10 senior administrative officer interview questions and answersannababy1245
This document provides information and resources for preparing for a senior administrative officer interview. It lists the top 10 interview questions for this role and provides detailed answers to each question. It also includes additional useful materials such as links to ebooks on common interview questions and secrets to winning job interviews, as well as sample cover letters and resumes. The document aims to help candidates understand the types of questions they may be asked and how to formulate strong, well-supported answers.
Top 10 assistant executive director interview questions and answersmickyhihi45
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Similar to Top 10 regulatory affairs manager interview questions and answers (20)
Top 10 chief innovation officer interview questions and answers
Top 10 regulatory affairs manager interview questions and answers
1. Top 10 regulatory affairs manager interview
questions and answers
In this file, you can ref interview materials for regulatory affairs manager such as types
of interview questions, regulatory affairs manager situational interview, regulatory
affairs manager behavioral interview…
Other useful materials for regulatory affairs manager interview:
• topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
• topinterviewquestions.info/13-types-of-interview-questions-and-how-to-face-them
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• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
2. 1. Why do you want this regulatory affairs manager job?
Again, companies want to hire people
who are passionate about the job, so you
should have a great answer about why
you want the position. (And if you don't?
You probably should apply elsewhere.)
First, identify a couple of key factors that
make the role a great fit for you (e.g., “I
love customer support because I love the
constant human interaction and the
satisfaction that comes from helping
someone solve a problem"), then share
why you love the company (e.g., “I’ve
always been passionate about education,
and I think you guys are doing great
things, so I want to be a part of it”).
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
3. 2. What have you learned from mistakes on the regulatory
affairs manager job?
Candidates without specific examples often
do not seem credible. However, the example
shared should be fairly inconsequential,
unintentional, and a learned lesson should
be gleaned from it. Moving ahead without
group assistance while assigned to a group
project meant to be collaborative is a good
example.
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
4. 3. What challenges are you looking for in this regulatory
affairs manager position?
A typical interview question to determine what you
are looking for your in next job, and whether you
would be a good fit for the position being hired for,
is "What challenges are you looking for in a
position?"
The best way to answer questions about the
challenges you are seeking is to discuss how you
would like to be able to effectively utilize your
skills and experience if you were hired for the job.
You can also mention that you are motivated by
challenges, have the ability to effectively meet
challenges, and have the flexibility and skills
necessary to handle a challenging job.
You can continue by describing specific examples
of challenges you have met and goals you have
achieved in the past.
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
5. 4. Describe a typical work week for regulatory affairs
manager position?
Interviewers expect a candidate for employment to
discuss what they do while they are working in
detail. Before you answer, consider the position
you are applying for and how your current or past
positions relate to it. The more you can connect
your past experience with the job opening, the
more successful you will be at answering the
questions.
It should be obvious that it's not a good idea talk
about non-work related activities that you do on
company time, but, I've had applicants tell me how
they are often late because they have to drive a
child to school or like to take a long lunch break to
work at the gym.
Keep your answers focused on work and show the
interviewer that you're organized ("The first thing I
do on Monday morning is check my voicemail and
email, then I prioritize my activities for the week.")
and efficient.
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
6. 5. What is your biggest weakness?
No one likes to answer this question because it
requires a very delicate balance. You simply can’t
lie and say you don’t have one; you can’t trick the
interviewer by offering up a personal weakness
that is really a strength (“Sometimes, I work too
much and don’t maintain a work-life balance.”);
and you shouldn’t be so honest that you throw
yourself under the bus (“I’m not a morning person
so I’m working on getting to the office on time.”)
Think of a small flaw like “I sometimes get
sidetracked by small details”, “I am occasionally
not as patient as I should be with subordinates or
co-workers who do not understand my ideas”, or “I
am still somewhat nervous and uncomfortable with
my public-speaking skills and would like to give
more presentations and talk in front of others or in
meetings.” Add that you are aware of the problem
and you are doing your best to correct it by taking
a course of action.
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
7. 6. Why should the we hire you as regulatory affairs manager
position?
This is the part where you link your skills,
experience, education and your personality to the
job itself. This is why you need to be utterly
familiar with the job description as well as the
company culture. Remember though, it’s best to
back them up with actual examples of say, how
you are a good team player.
It is possible that you may not have as much skills,
experience or qualifications as the other
candidates. What then, will set you apart from
the rest? Energy and passion might. People are
attracted to someone who is charismatic, who
show immense amount of energy when they talk,
and who love what it is that they do. As you
explain your compatibility with the job and
company, be sure to portray yourself as that
motivated, confident and energetic person, ever-
ready to commit to the cause of the company.
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
8. 7. What do you know about our company?
Follow these three easy research tips before your next
job interview:
1) Visit the company website; look in the “about us”
section and “careers” sections
2) Visit the company’s LinkedIn page (note, you must
have a LinkedIn account — its free to sign up) to view
information about the company
3) Google a keyword search phrase like “press releases”
followed by the company name; you’ll find the most
recent news stories shared by the company
Remember, just because you have done your
“homework”, it does not mean you need to share ALL of
it during the interview! Reciting every fact you’ve
learned is almost as much of a turn off as not knowing
anything at all! At a minimum, you should include the
following in your answer:
1. What type of product or service the company sells
2. How long the company has been in business
3. What the company culture is like OR what the
company mission statement is, and how the culture
and/or mission relate to your values or personality
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
9. 8. Why do you want to work with us?
More likely than not, the interviewer wishes to see
how much you know about the company culture,
and whether you can identify with the
organization’s values and vision. Every
organization has its strong points, and these are the
ones that you should highlight in your answer. For
example, if the company emphasizes on integrity
with customers, then you mention that you would
like to be in such a team because you yourself
believe in integrity.
It doesn’t have to be a lie. In the case that your
values are not in line with the ones by the
company, ask yourself if you would be happy
working there. If you have no issue with that, go
ahead. But if you are aware of the company culture
and realize that there is some dilemma you might
be facing, you ought to think twice. The best
policy is to be honest with yourself, and be honest
with the interviewer with what is it in the company
culture that motivates you.
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
10. 9. Did the salary we offer attract you to this regulatory
affairs manager job?
The interviewer could be asking you this
question for a number of reasons.
Obviously, the salary is an important factor
to your interest in this job, but it should not
be the overriding reason for your interest. A
good answer to this question is, “The salary
was very attractive, but the job itself is what
was most attractive to me.”
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
11. 10. Do you have any questions to ask us?
Never ask Salary, perks, leave, place of
posting, etc. regarded questions.
Try to ask more about the company to show
how early you can make a contribution to
your organization like
“Sir, with your kind permission I would like
to know more about induction and
developmental programs?”
OR
Sir, I would like to have my feedback, so that
I can analyze and improve my strengths and
rectify my shortcomings.
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
16. Other interview tips for regulatory affairs manager interview
1. Practice types of job interview such as screening
interview, phone interview, second interview,
situational interview, behavioral interview
(competency based), technical interview, group
interview…
2. Send interview thank you letter to employers
after finishing the job interview: first interview,
follow-up interview, final interview.
3. If you want more interview questions for entry-
level, internship, freshers, experienced candidates,
you can ref free ebook: 75 interview questions and
answers.
4. Prepare list of questions in order to ask the
employer during job interview.
5. Note: This file is available for free download.
Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews
17. Fields related to regulatory affairs manager career:
The above job description can be used for fields as:
Construction, manufacturing, healthcare, non profit, advertising, agile, architecture, automotive,
agency, budget, building, business development, consulting, communication, clinical research,
design, software development, product development, interior design, web development,
engineering, education, events, electrical, exhibition, energy, ngo, finance, fashion, green card, oil
gas, hospital, it, marketing, media, mining, nhs, non technical, oil and gas, offshore,
pharmaceutical, real estate, retail, research, human resources, telecommunications, technology,
technical, senior, digital, software, web, clinical, hr, infrastructure, business, erp, creative, ict,
hvac, sales, quality management, uk, implementation, network, operations, architectural,
environmental, crm, website, interactive, security, supply chain, logistics, training, project
management, administrative management…
The above interview questions also can be used for job title levels: entry level regulatory affairs
manager, junior regulatory affairs manager, senior regulatory affairs manager, regulatory affairs
manager assistant, regulatory affairs manager associate, regulatory affairs manager administrator,
regulatory affairs manager clerk, regulatory affairs manager coordinator, regulatory affairs
manager consultant, regulatory affairs manager controller, regulatory affairs manager director,
regulatory affairs manager engineer, regulatory affairs manager executive, regulatory affairs
manager leader, regulatory affairs manager manager, regulatory affairs manager officer,
regulatory affairs manager specialist, regulatory affairs manager supervisor, VP regulatory affairs
manager…Useful materials: • topinterviewquestions.info/free-ebook-80-interview-questions-and-answers
• topinterviewquestions.info/free-ebook-top-18-secrets-to-win-every-job-interviews