The following are some useful regulatory websites accorss the globe.
Clinical Research, Pharmacovigilance (PV) and Regulatory Website Listing.
|Sl. No||Regulatory Authority (RA) / Independent Authority (IA)||RA/IA||Regulatory Authority Links & Sub Links||Brief Explanation regarding the link|
|1||European Medicine Agency (EMA)||RA||http://www.ema.europa.eu/ema/||This link includes patient safety, new medicines and public consultations (link sub tabs includes find medicine, human regulatory, veterinary regulatory, committee, news and events, partners and networks)|
|2||European Medicine Agency (EMA)||RA||http://www.ema.europa.eu/ema/
|This links includes ommittees, working parties and other groups|
|3||European Medicine Agency (EMA)||RA||http://www.ema.europa.eu/ema/
|This links provides information for companies and individuals involved in developing and marketing medicines for human use in the European Union (EU).|
|4||Medicines & Healthcare products Regulatory Agency (MHRA, UK)||RA (National Competent Authority)||https://www.gov.uk/government/
|This link includes Drug and Device alert, Drug safety updates, Report a problem with a medicine or medical device, Blood regulation and safety, Marketing authorizations and licensing guidance, Patient information leaflets and summaries of product characteristics, Drug Analysis Prints (DAPs), Public assessment reports and Medical devices regulation and safety Contact MHRA and All MHRA services and information.|
|5||Medicines & Healthcare products Regulatory Agency (MHRA, UK)||RA (National Competent Authority)||https://www.gov.uk/
|This link includes Drug safety updates|
|6||Federal Agency for Medicines and Health Products (Belgium)||RA (National Competent Authority)||http://www.fagg-afmps.be/en/||This link includes human medicine, veterinary medicines information for the public notification of adverse reactions or incidents.|
|7||State instituute for drug control (Czech Republic)||RA (National Competent Authority)||http://www.sukl.eu/index.php||This link includes medicines, medical devices, pharmacies, healthcare facilities, pharmaceutical industries, distribution and functions of State institute for drug control|
|8||National Agency for the Safety of Medicine and Health Products (France)||RA (National Competent Authority)||http://ansm.sante.fr/||This link includes health products, report an adverse reactions, services, publications, records, activities and function of ANSM (National Agency for the Safety of Medicine and Health Products).|
|9||Federal Institute for Drugs and Medical Devices (Federal Institute for Drugs and Medical Devices)||RA (National Competent Authority)||http://www.bfarm.de/EN/
|This link includes about Bfarm agnecy, medicinal products, medical device, Federal opium agency, research and services.|
|10||Italian Medicines Agency||RA (National Competent Authority)||http://www.agenziafarmaco
|This link includes about AIFA, activities and director general.|
|11||Spanish Agency for Medicines and Health Products||RA (National Competent Authority)||http://www.aemps.gob.es/||This link includes Surveillance, clinical research, legislation and publications|
|12||Medical Products Agency (MPA)||RA (National Competent Authority)||https://lakemedelsverket.se/||This link includes health care, pharmacy and trade, public, Business, press|
|13||Swiss Agency for Therapeutic products||RA (National Competent Authority)||https://www.swissmedic.ch/
|This link includes news, medicinal product information, medical devices, authorizations, licensing, market surveillance and functions of agency|
|North and South America|
|14||The Brazilian Health Surveillance Agency (ANVISA-Brazil)||RA|| http://portal.anvisa.gov.
|This link includes health protection, education and knowledge, news, post marketing surveillance and about agency.|
|15||Health Canada (Canada)||RA||http://www.hc-sc.gc.ca/
|This link includes about health Canada, consumer product safety, drugs and health products, environmental and work health, food nutrition and science and research.|
|16||USA (U.S. Food and Drug Administration)||RA||http://www.fda.gov/||This link includes about food, drug, medical devices, radiation-emitting products, vaccines, blood and biologics, animal and veterinary, cosmetics and tobacco products|
|Asia, The Middle East and Ocean|
|17||Drug administration of Vietnam (Vietnam RA)||RA||http://www.dav.gov.vn/
|English version is under construction|
|18||Therapeutic Goods Administration (TGA), Australia||RA||https://www.tga.gov.au/||This link gives information on safety, useful information to health professionsal & consumers, pharmaceutical industry & regulatry authority in Australia.|
|19||China Food and Drug Administration (CFDA)||RA||http://eng.sfda.gov.cn/
|This link provides information about CFDA, regulatory guide to medical devices, imported products, drug law, food & cosmetics in China.|
|20||Egyptian Drug Authority (EDA||RA||http://www.eda.mohealth.gov.eg/||This link provides information about Egyptian Drug Authority (EDA), legislation, safety & quality etc.|
|21||The National Agency of Drug & Food Control (NA-DFC)||RA||http://www.pom.go.id
|This link provides information about Indonesia regulatory authority (NA-DFC).|
|22||Drug Regulatory Authority of Pakistan (DRAP)||RA||http://www.dra.gov.pk/gop
|This link gives information about 1.Drug Regulatory Authority of Pakistan Act, 2012, 2. Drugs Act, 1976 3. SROs4. The Drugs (Labelling and Packing) Rules, 19865. The Drugs (Licensing, Registering & Advertising) Rules, 19766. The Drugs (Appellate Board) Rules, 19767. The Drugs (Research) Rules, 19788. The Drugs (Federal Inspectors, Federal Drug Laboratory & Federal Government Analysts) Rules, 19769. The Drugs (Imports & Exports) Rules, 197610. The Drugs (Specifications) Rules, 197811. The Northern Areas Drugs Rules, 199612. Pharmacy Act, 1967|
|23||Food And Drug Administration Philippines||RA||http://www.fda.gov.ph/
|This link provides general infrormation Philippines drug regulatory authority.|
|24||Food And Drug Administration Philippines||RA||http://www.fda.gov.ph/consumers-corner/registered-drugs-2||This link provides infrormation on drugs approved in Philippines.|
|25||Food And Drug Administration Philippines||RA||http://www.fda.gov.ph/||This link provides infrormation on registered vaccines and biological products in Philippines.|
|26||Korea Food and Drug Administration (KFDA)||RA||http://eng.kfda.go.kr/index.html||This link provides general infrormation Korea drug regulatory authority.|
|27||Pharmaceuticals & Medical devices Agency (PMDA)||RA||http://www.pmda.go.jp/english/||This link provides the information pertaining to the Regulatory authority (Japan specific), information useful for healthcare professionals, academic information related to pharmaceuticals & pharmaceuticals business purpose. This link also gives information related to the postmarketing safety measures, releif services for adverse health effect, regulatory science & standard development, & international activities.|
|Other Links - Useful Websites and Professional Organizations|
|The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)||http://www.ich.org|
|The National Cancer Institute (NCI) and clinical trails||http://www.cancer.gov/clinicaltrials|
|ClinicalTrials.gov - registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.||http://www.clinicaltrials.gov/|
|Source for Clinical Research Information and Data||http://www.centerwatch.com/|
|Clinical Research and the HIPAA Privacy Rule||http://privacyruleandresearch.nih.gov/clin_research.asp|
|E6 Good Clinical Practice Consolidated Guidance||http://www.fda.gov/
|Association of Clinical Research Professionals||www.acrpnet.org|
|Regulatory Affairs Professional Society||www.raps.org|
|American Medical Writer Association||www.amwa.org|
|American Association of Pharmaceutical Scientists||www.aaps.org|
|Society for Clinical Data Management||www.scdm.org|
|Source of Information||Website link|
|The largest independent vendor in the business intelligence market||http://www.sas.com/|
|SAS Press and SAS Documentation Example Code and Data||http://support.sas.com/|
|Related to Clinical SAS|
|Global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata||http://www.cdisc.org/|
|U.S. Food and Drug Administration (FDA)||http://www.fda.gov|
|ClinicalTrials.gov - registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.||http://www.clinicaltrials.gov/|
|Society for Clinical Data Management||http://scdm.org/|
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QTECH SOLUTIONS INC, Doing Business As "Qtech-Sol Professional Development Center" (QPDC) is a Professional and Management Development Training Organization (NAICS 611430). We develop various Job Oriented Training Programs to individual students, looking to expand career opportunities as highly skilled professionals. E-verified with Immigration.
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Program Delivery Models:
Unpaid Internship programs
Franchiser Licensee Support
We as Clinical Data Management Organization, provide product development services to the pharmaceutical, biotechnology, and medical device industries getting involved in approximately two-thirds of all Phase I - IV clinical trials, Our CDM professionals bring their scientific, regulatory and information management expertise to bear for the completion of timely, accurate, cost-effective trials and even controlling costs and reducing the research and development timelines.Services Offered:
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Qtech's Primary Consulting services include providing corporate training and supporting its clients with right candidate to meet their contractual and full-time human resource needs. We support various consultants towards Clinical Research, Drug Safety / Pharmacovigilance, Business Analysis, Reporting, Medical Writing and Safety Reviewers. Support towards Clinical Trial, Monitoring and Medical Safety, Healthcare Business and Project management services for pharmaceutical Research, Hospital, Medical Healthcare, Financial and Investment Banking firms.
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Most professionals hired and working at Qtech hold Bachelor or Master degree in Medicine, PharmD, Nursing (RN), Health Care Administration, Public Health, Pharmaceutical Engineering, Pharmaceutics, Pharmacology, Toxicology, Industrial Chemistry, Computer Science and Information Technology, Bioinformatics, Statistics & Biostatistics, Business Administration (Marketing). Our Objective is to support various pharmaceutical, healthcare and research organization by providing project management and staffing resources to meet cost efficiency, times saved and commitment to full-fill.
Our project managers are client focused and in charge of the clinical team for the duration of your clinical trial or drug development program. With a company-wide standard for quality and integrity, Qtech encourages team ownership of each clinical trial and is dedicated to its successful execution.
Our Clinical Research Project Management Services are:
Our project managers are responsible for the overall conduct of a Safety study, ensuring PV and Clinical Quality Assurance, Reporting and Medical Writing and Reporting, Evaluation, and Assessment. They provide leadership and oversight to our study teams and serve as a single point of contact for our sponsors. Qtech offers comprehensive services that supports various Pharmacovigilance Operations on time and on-budget.
Our experienced Drug Safety Physicians, Drug Safety and Pharmacovigilance Officers support monitoring, data collection and analysis, and reporting of medical safety information for compliance and meet regulations imposed.
Qtech Professional Development Center (QPDC) is a Private Vocational School (PVS) approved by New Jersey Department of Education and Department of Labor and Workforce Development.
We are one of selected professional training providers which offer professional occupational education and job training opportunities that have been approved by the appropriate State agency and listed on New Jersey State Eligible Training Provider list (ETPL).QPDC satisfied specific eligibility criteria established by both the State Employment and Training Commission (SETC) and the local Workforce Investment Board (WIB) to be eligible to receive students paid for with public funds. Based on given State approvals, many QPDC's students who are eligible for training grants receive 100% funding to join and successfully complete our job oriented training programs.
You can find us on New Jerseys Eligible Training Provider List (ETPL) by going to the states website at http://www.njtrainingsystems.org/ and select "get started & search for training".
To view professional training programs offered by QPDC that are eligible for New Jersey state training grants 'Click Here'.
To find out about eligibility factors for state training grants, please contact us at email@example.com or visit nearest One Stop Career Center 'Click Here'.
No. Prior to starting our program, each trainee needs to be screened and interviewed. The education background is required. Qtech is for individuals who want to develop new set of skills, gain additional experience, or desire career transition.
The essence of our professional job oriented programs is gaining experience and working on real time scenario projects. We do not provide any curriculum based training, thus certain education background is required. Qtech provides training based on industry requirements and job qualifications. After completing our training you are not only certified, but also have experience you were missing and you are already qualified for entry/mid level positions.
The length of the training depends on the candidate's qualifications and previous experience. The training takes from 45 days to 90 days and depends on type and advance level of the training.
Minimum of 75% score is required to pass the final test and receive the Certificate of Completion. If you fail, you should contact us immediately at firstname.lastname@example.org and 2nd attempt will be provided within next 7 days.
Most of our trainees are full time students or employees. The relocation is not required for successfully program completion. You have 24/7 access to the material.
We recommend minimum 2 hours a day.
Yes. Qtech are approved. Please approach one of your closes one stop center.
Yes. Qtech is E-verified and an Equal Employment Opportunities (EEO) provider. We support our international students working with Qtech on CPT and OPT status.
Yes. However, we need first to evaluate your eligibility. There are two factors we consider: (1) preselection prior to the training start - interview is required; (2) training performance - final training performance evaluation is required.
|Winter - Clinical Science Programs|
|Q-IN-W2018-PS101||Clinical Research Associate - Internship||12 Weeks / Weekly 20 Hours||Onsite||0-2 Years||11-09-2018|
|Q-IN-W2018-PS100||Drug Safety Associate – Internship||12 Weeks / Weekly 20 Hours||Onsite||0-2 Years||11-09-2018|
|Q-IN-W2018-PS099||Clinical Data Management - Internship||12 Weeks / Weekly 20 Hours||Onsite||0-2 Years||11-09-2018|
|Q-IN-W2018-PS098||Clinical SAS Programmer - Internship||12 Weeks / Weekly 20 Hours||Onsite||0-2 Years||11-09-2018|
|Q-IN-W2018-PS097||Healthcare Business Analyst - Internship||12 Weeks / Weekly 20 Hours||Onsite||0-2 Years||11-09-2018|