Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Best Practices - Injectable Packaging LinesManish Bhatkar
In the past couple of years we have seen many companies recalling sterile products, primarily due to the problems related to particulate matter and/ or sterility assurance. These problems are not only a potential threat to the patient health, but also lead to short supply due to contamination, manufacturing problems, or product discontinuation. Sterile dosage forms are vulnerable to both microbial and particulate contamination, which has been traced to glass and packaging materials, problems such as leaching and sorption and moreover the manufacturing/ operating practices.
Recently, in an industry workshop I had shared my thoughts, views, experiences and study findings on this topic and I am happy to share the same with you. I hope this will be useful…
A due diligence Annual progress report for the CLINCHEM Department (www.clinchem.kasralainy.edy.eg)
An assessment tool for over all productivity and development of Education, Research and Laboratory healthcare services.
Highlights:
1- Mission, Vision and objectives
2- Role of the Department
3- HR
4- Organogram for the year
5- Lab Services
6- Scientific Research
7- Projects and more
Innovating solutions for pharma research & developmentJohn Douglas
Lotus Labs is a Clinical Research Organization with extensive experience in conducting Clinical Trials in healthy volunteers, patient populations and special populations.
Presentation given by Miquel Borràs from Barcelona Science Park in the framework of the Emergence Forum Barcelona
Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation.
More information at: http://www.b2match.eu/emergenceforum2014
Medicilon is an integrated contract research organization (CRO), providing comprehensive one-stop R&D services for pharmaceutical enterprises and scientific research institutions around the world. https://www.medicilon.com/
A due diligence Annual progress report for the CLINCHEM Department (www.clinchem.kasralainy.edy.eg)
An assessment tool for over all productivity and development of Education, Research and Laboratory healthcare services.
Highlights:
1- Mission, Vision and objectives
2- Role of the Department
3- HR
4- Organogram for the year
5- Lab Services
6- Scientific Research
7- Projects and more
TNO Triskelion BSL-3 lab tests anti-viral drugs in newly developed H7N9 influenza model
Human infections with a new avian influenza A (H7N9) virus were first reported in China in 2013, with the loss of 46 lives. In order to meet the growing needs to test new drugs against H7N9, TNO Triskelion has recently developed an H7N9 mouse model. This H7N9 model is suitable for testing new anti-virals such as vaccines, monoclonal antibodies and small molecules in our BSL-3 lab, in conformity with Good Laboratory Practice. TNO Triskelion has proven to be a successful partner in the development of new anti-viral and anti-bacterial vaccines for many years. Understanding the pressures on time lines, we support companies and institutes during the preclinical and clinical stages of drug development.
Any medical trial or clinical research is incomplete without a clinical laboratory. Traditionally speaking, a clinical laboratory examines and analyses components in blood, urine and body fluids... Blood grouping & Rh typing can also be performed.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Best Practices - Injectable Packaging LinesManish Bhatkar
In the past couple of years we have seen many companies recalling sterile products, primarily due to the problems related to particulate matter and/ or sterility assurance. These problems are not only a potential threat to the patient health, but also lead to short supply due to contamination, manufacturing problems, or product discontinuation. Sterile dosage forms are vulnerable to both microbial and particulate contamination, which has been traced to glass and packaging materials, problems such as leaching and sorption and moreover the manufacturing/ operating practices.
Recently, in an industry workshop I had shared my thoughts, views, experiences and study findings on this topic and I am happy to share the same with you. I hope this will be useful…
A due diligence Annual progress report for the CLINCHEM Department (www.clinchem.kasralainy.edy.eg)
An assessment tool for over all productivity and development of Education, Research and Laboratory healthcare services.
Highlights:
1- Mission, Vision and objectives
2- Role of the Department
3- HR
4- Organogram for the year
5- Lab Services
6- Scientific Research
7- Projects and more
Innovating solutions for pharma research & developmentJohn Douglas
Lotus Labs is a Clinical Research Organization with extensive experience in conducting Clinical Trials in healthy volunteers, patient populations and special populations.
Presentation given by Miquel Borràs from Barcelona Science Park in the framework of the Emergence Forum Barcelona
Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation.
More information at: http://www.b2match.eu/emergenceforum2014
Medicilon is an integrated contract research organization (CRO), providing comprehensive one-stop R&D services for pharmaceutical enterprises and scientific research institutions around the world. https://www.medicilon.com/
A due diligence Annual progress report for the CLINCHEM Department (www.clinchem.kasralainy.edy.eg)
An assessment tool for over all productivity and development of Education, Research and Laboratory healthcare services.
Highlights:
1- Mission, Vision and objectives
2- Role of the Department
3- HR
4- Organogram for the year
5- Lab Services
6- Scientific Research
7- Projects and more
TNO Triskelion BSL-3 lab tests anti-viral drugs in newly developed H7N9 influenza model
Human infections with a new avian influenza A (H7N9) virus were first reported in China in 2013, with the loss of 46 lives. In order to meet the growing needs to test new drugs against H7N9, TNO Triskelion has recently developed an H7N9 mouse model. This H7N9 model is suitable for testing new anti-virals such as vaccines, monoclonal antibodies and small molecules in our BSL-3 lab, in conformity with Good Laboratory Practice. TNO Triskelion has proven to be a successful partner in the development of new anti-viral and anti-bacterial vaccines for many years. Understanding the pressures on time lines, we support companies and institutes during the preclinical and clinical stages of drug development.
Any medical trial or clinical research is incomplete without a clinical laboratory. Traditionally speaking, a clinical laboratory examines and analyses components in blood, urine and body fluids... Blood grouping & Rh typing can also be performed.
Fact sheet presenting the life sciences industry in the Quebec City region. Produced by Quebec International. http://quebecinternational.ca/key-industries/
A due diligence Annual progress report for the CLINCHEM Department (www.clinchem.kasralainy.edy.eg)
An assessment tool for over all productivity and development of Education, Research and Laboratory healthcare services.
Highlights:
1- Mission, Vision and objectives
2- Role of the Department
3- HR
4- Organogram for the year
5- Lab Services
6- Scientific Research
7- Projects and more
1. Company Description:
The Laboratory is a Hong Kong-based and privately owned medical laboratory. It
was established in 1981 by two pathologists in response to a need for a variety of
laboratory services not available then. During the last 34 years, its services have
developed, expanded and modified to meet the needs of clients. The laboratory is
now a modern laboratory, fully equipped with state-of-the-art instrumentation.
The laboratory has over 80 professional trained staff, including pathologists,
radiologists, registered medical technologists, radiographers, phlebotomists,
administrators, scientists, as well as accounting, information technology,
marketing, clerical and courier personnel. The laboratory has five existing
departments and they are 1) chemical pathology; 2) haematology; 3) clinical
microbiology & infection; 4) immunology; 5) molecular genetics.
In addition to these service departments, it has a department of research &
development to carry out clinical research, and to collaborate with the
department of pathology (The University of Hong Kong) for basic medical
research. To ensure the good standard of laboratory, it is accredited by the
HOKLAS Accreditation for medical testing ISO 15189. It was accredited by the
Trent Accreditation Scheme (UK) when it provided medical laboratory and blood
banking service for a private hospital from 2002-2011.
Along with its clinical laboratory testing services, it also offer phlebotomy
service, X-ray, ultrasonography, FibroScan, dual-energy X-ray absorptiometry
(DEXA), mammorgraphy, and electrocardiography. Its clients are mostly private
practice doctors and specialists, and medical group practices, with other clients
including the Hospital Authority, private hospitals, other laboratories, tertiary
institutions, pharmaceutical and insurance companies.