A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
TGA changes for Medical Devices in AustraliaJoe Hage
http://MedicalDevicesGroup.net Sydney-based regulatory affairs expert Arthur Brandwood discusses the recent changes made by the Australian Therapeutic Goods Administration (TGA).
He also covers:
• Australia’s aggressive deregulatory agenda
• The Australian tax incentive (43.5% for R&D expenditure)
• The simple process for regulation of clinical trials in Australia
• TGA’s web based submission process for device approvals
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
TGA changes for Medical Devices in AustraliaJoe Hage
http://MedicalDevicesGroup.net Sydney-based regulatory affairs expert Arthur Brandwood discusses the recent changes made by the Australian Therapeutic Goods Administration (TGA).
He also covers:
• Australia’s aggressive deregulatory agenda
• The Australian tax incentive (43.5% for R&D expenditure)
• The simple process for regulation of clinical trials in Australia
• TGA’s web based submission process for device approvals
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Why to conduct clinical trials in Ukraine? Ukrainian CRODariaAbulova
- Why to conduct clinical trials in Ukraine?
- Who we are - JERELO CRO
- Area of expertise of JERELO
- Cardio surgery case of JERELO CRO
- Stages of MD lifecycle and our facilities for clinical researches on its every stage
- Regulatory services and services of the Authorized Representative in Ukraine
All these issues are described in our presentation.
JERELO is your reliable CRO in Ukraine.
Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies To Ensure...Best Practices
In the face of cost and regulatory pressures, clinical programs at medical device organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets. However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions.
Best Practices®, LLC conducted primary research to inform clinical affairs leaders at medical device companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.
Critical outsourcing questions addressed in this survey include:
-What are the regions where medical device companies are conducting clinical trials and the percent of patients recruited annually from these regions?
-Which clinical trial activities are best suited for outsourcing?
-What is the appropriate staffing mix (in-house and outsourced) for clinical trials?
-What are the most important competencies for clinical research associates, managers, and directors?
This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767
Why to conduct clinical trials in Ukraine? Ukrainian CRODariaAbulova
- Why to conduct clinical trials in Ukraine?
- Who we are - JERELO CRO
- Area of expertise of JERELO
- Cardio surgery case of JERELO CRO
- Stages of MD lifecycle and our facilities for clinical researches on its every stage
- Regulatory services and services of the Authorized Representative in Ukraine
All these issues are described in our presentation.
JERELO is your reliable CRO in Ukraine.
Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies To Ensure...Best Practices
In the face of cost and regulatory pressures, clinical programs at medical device organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets. However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions.
Best Practices®, LLC conducted primary research to inform clinical affairs leaders at medical device companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.
Critical outsourcing questions addressed in this survey include:
-What are the regions where medical device companies are conducting clinical trials and the percent of patients recruited annually from these regions?
-Which clinical trial activities are best suited for outsourcing?
-What is the appropriate staffing mix (in-house and outsourced) for clinical trials?
-What are the most important competencies for clinical research associates, managers, and directors?
This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
Current regulatory challenges in indian pharmaceutical industryVikas Rathee
India is the 3rd largest in terms of volume and 13th in terms of value all over the world as we still struggle in terms of quality so in this ppt i show some challenges faced by Indian Pharmaceutical Industry
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 3 has been released with
News Uptoday
New Guidelines
Audit Findings
Guest of the Month
Regulation of the Month
Schedule Y1 set to check fly-by-night operators in clinical trial sector
1. Schedule Y1 set to check fly-by-night operators in
clinical trial sector
Thursday, August 06, 2009 08:00 IST
Nandita Vijay, Bangalore
The Schedule Y1 Draft Rules, which are under scrutiny by the Clinical Research
Organizations (CROs) in the country, have been broadly welcomed by most of them.
Key provisions of the Rules namely 122DA, 122DAA and 122 DAB are expected to
check the fly-by-night operators who are rampant in the sector.
The proposed draft, approved by Drug Technical Advisory Board (DTAB), has
provided 45 days window period (issued June 30, 2009) for suggestions to the Central
Drug Standard Control Organization which should end by mid August.
While Schedule Y1 is a 5 year operating license for CROs, the Clinical Trial Registry
India (CTRI), mandated from June 15, maintains details of human studies. Together
these provide accountability, transparency and regulate the sector, said Shekhar
Gupta, chief operating officer, D2L Pharma Research Solutions.
The regulation and the Registry are expected to check unscrupulous practices of the
small CROs. But the challenge in a trial is to track the volunteers who participate in
several studies at the same time for different companies as their traceability is
difficult, said M Prashanth Babu, principal consultant - Audits, Vaatsalya Clinical.
The regulation reinforces confidence on Indian CROs. The registry which provides
overseas clients a database to reckon credentials before awarding the trial has more
scope for improvement. Some features of US FDA's clinical trial registry could be
added on. There should be more clarity on data entry guidelines. It should be clear
that the trials which are approved after June 15, 2009 are mandated to be registered.
Currently many Institutional Ethics Committee /Institutional Review Board are
requesting for CTRI registration numbers that were granted approval in 2007-08, said
Thanuja Naidu, country head & manager-Clinical Operations, Pharm-Olam
International (India) Pvt Ltd.
The concept of 'guinea pigs' to test drugs will now cease to exist. With Schedule Y1
guideline implementation round the corner, Indian CRO's can ward off criticism that
trials conducted here are unethical and sub-standard practices are followed. While the
pharma industry has welcomed the move, small CROs apparently do not seem to be
happy with the creation of a single window for licenses or with the registration as they
feel this would benefit multinational companies, said Sudhakar D R, director & head -
Media Services, Empower Research Knowledge Services.
2. Indian clinical research industry is valued at Rs 1000 crore. Of the 200 CROs only a
handful are visible. These include Quintiles, Siro Pharma, Veeda, Clinigene, Neeman,
Icon, GSK, Novartis, Eli Lily, Ecron Acunova, Lotus Labs, Vimta, GVK Biosciences,
Clinigene, the Biocon subsidiary. Almost 80 percent of the outsourced assignments in
clinical research is information technology related where Accenture, TCS, Cognisant,
Infosys are chipping in their expertise. This is followed by Bio-analytical and
Bioequivalence (BA/BE) studies, data management and patient recruitment. Among
the Indian CROs Siro Pharma is the largest followed by Veeda and Ecron Manipal in
terms of revenues, stated sources.
Link : http://www.pharmabiz.com/article/detnews.asp?articleid=51060§ionid
