Internal Auditor Training Program As Per Iso 13485:2016 Standard
IBSC (Indian Biomedical Skill Consortium) is conducting Internal Auditor Training Program on ISO 13485:2016 – Medical Device Quality Management System
COURSE OUTCOMES:
a. Use of ISO13485:2016 as the basis for a QMS for medical device manufacturers b. Ways to increase effective manufacturing of medical devices and cost savings through quality management c. Supply chain monitoring to achieve continuous improvement· d. Understanding how to meet regulatory requirements leading to increased patient safety
Duration: 3 Days (12th, 13th & 14th October 2023) Mode: Online (Hybrid mode) Eligibility: Any (Working Professionals & Interested Student
Discount: 25% to AMTZ Manufactures; AiMeD Members, IBSC Partners For quotation send email to n.nareshkumar@ibsc-amtz.in
HOSPEX Healthcare Expo cum Conferences 2023 – SEP 15-17,2023 at Zamra International Convention Centre, Kochi, Kerala
The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs.
Experience the Next Generation of Healthcare at HOSPEX Healthcare Expo in Kerala! Join us as we bring together leading manufacturers and suppliers from the medical industry to showcase cutting-edge medical equipment and innovations. From state-of-the-art imaging technology to advanced surgical instruments, explore the latest advancements that are shaping the future of healthcare.
2nd Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Sep 15th – 17th 2023. This is Kerala’s first B2B Medical Expo which will take place at Zamra International Convention and Exhibition Center, Kochi, Kerala.
HOSPEX 2023 Expo is the platform to showcase Technology, Products & Innovations to the healthcare fraternity.
Expo cum Conference Theme this year is on :
Future of Healthcare – Device | Digital | Diagnostics
Don’t miss this exclusive opportunity to witness the forefront of medical technology under one roof at the HOSPEX Healthcare Expo.
HOSPEX Expo has a projected walk-in of 10000+ professionals and entrepreneurs from all over South India including doctors, hospital owners, managers, supply & purchase staff, distributors that are all from the medical industry.
HOSPEX is the Convergence platform where Makers (Medical Device Manufacturers) , Users (Healthcare Establishments) and Innovators (MedTech, HealthTech, Digital Health Innovators, FinTech, Insuretech, CyberTech etc) and Governments , Policy Makers join the connected conversations to strengthen and improve the Healthcare Ecosystem in the country.
The core focus of HOSPEX Healthcare Expo 2023 is medical knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry.
SMART Hospitals Conference
Date : Sep 16, 2023
Time : 10 00 am to 6 00 pm
Fee : Rs 500 per delegate
SMART Hospitals Conference focus is to enable Micro and Small Hospitals to Go Digital, use various HealthTech and MedTech Solutions – be it for Clinical Decision Support Solutions, Tech Solutions to help Hospitals to streamline their day to day practices, Tech solutions to improve productivity of healthcare workforce, Technologies that facilitate Quality and Safe Patient Care.
Conference will connect SMART Technologies, Solutions that are needed in healthcare settings as Future of Healthcare will be driven by Practitioners , Healthcare Settings using SMART Devices, Diagnostics and Digital Solutions.
Conference Outline :
SMART Medical Technologies help Practitioners to improve service standards
SMART Medical Device for Safe Patient care in Clinical Settings , Home Healthcare Setting
Testing and Certification of SMART Medical Devices – Global Regulations and Certification Requirements
Empowering Practitioners : Virtual Cardiac Care Diagnostic Solutions
Telehealth and Telemedicine – NMC Regulations & Clinical Establishments
SMART Prescription for Prescribers – EHR Solution
SMART Technologies to enable Small Hospitals – Technology Session
SMART HealthTech Ecosystem
Digital Health Apps for Enhancing Patient Satisfaction, Loyalty and Referrals
Digital Ecosystems: Future of Healthcare – The Value for All: Patients, Healthcare organisations and Innovators, Startups
Smart Healthy Aging Tech Solutions
Target Audience :
Medical Professionals, Healthcare Professionals from Hospitals and other Healthcare organisations, HealthTech, MedTech Professionals , Startups, Innovators, Incubation Hubs, Medical Device Industry Representatives, Digital Health Teams, Quality Professionals, Regulatory Affairs Professionals and other stakeholders like Insurers, Governments, Regulators, Corporate Health & Wellness Teams, Corporate Medical Centers, Home Healthcare Service Providers etc
HOSPEX PURCHASE MANAGERS WORKSHOP – FOR BIOMEDICAL TEAMS, PROCUREMENTS TEAMS IN HOSPITALS AND OTHER HEALTHCARE SETTINGS
Venue: Zamra Convention Centre, Kochi, Kerala
Date : September 15, 2023
Time : 2 30 pm – 5 30 pm
Fee – Rs 250 + GST
Target Audience :
Healthcare Professionals Who are incharge of Procurement Practices in Hospitals and other Healthcare Settings
Medical Professionals, Promoters, Management Teams, Administrators, Purchase Teams, Biomedical Engineers, Finance Teams, Quality Teams , other functional heads who are interested in understanding more about Quality and Safety related Regulations of Hospital Supply Chain and Vendors .
Workshop shall cover following items that Hospitals Procure with special reference to:
– Biomedical Equipments
– Consumables and Disposables
– Standalone MedTech or Healthtech Software that is used for clinical decision support purpose
Program Objective :
Since Medical Devices, Health Technologies are part of the Value Chain of Hospital Supplies, its imperative for Procurement Teams, Purchase Managers, Finance Teams, Promoters , Quality Teams to learn more about Regulations and Compliances related to their Supply Chain , Value Chain of Hospitals (Suppliers and Vendors)
Hence HOSPEX has designed an Awareness Session covering the following topics for Hospital Teams who are incharge of Procurement :
Understanding Medical Device Regulations- Laws of the Land
Medical Device Regulations – Role of Bureau of Indian Standards
Foreign Regulations , Quality Specification – How its listed in other Key Global Regulations
Claims of Voluntary Certifications – How Authentic these claims are ?
Materiovigilance Program of India – Regulatory Requirement
Conference on“Industry 4.0 for MSMEs” on 23rd August 2023, Wednesday
The adoption of Industry 4.0 technologies, such as automation and IoT, is essential for the manufacturing of MSMEs in the future. These technologies provide substantial advantages, such as increased visibility, productivity, competitiveness, and efficiency, all of which are essential for MSME manufacturers to maintain their lead in the global market. MSME manufacturers can successfully adopt Industry 4.0 principles and modernize their processes to satisfy future demands.
Considering the importance of this, Andhra Chamber of Commerce in association with Friedrich Naumann Foundation for Freedom is organizing a Conference on “Industry 4.0 for MSMEs” on the 23rd August 2023 in Hotel Hyatt Regency, Anna Salai, Chennai from 10 a.m. to 4 p.m.
The learnings of the Conference will
make the MSMEs more competitive
make the MSMEs more attractive to the younger workforce
make the team stronger and more collaborative.
allow the MSMEs to address potential issues before they become big problems.
allow the MSMEs to trim costs, boost profits, and fuel growth
As the participation is only on the first come first served basis, please fill up the registration form and send it to Andhra Chamber of Commerce at the earliest.
Sebi – Regulatory Framework for value chain ESG disclosures for listed entities
Sebi came out with a regulatory framework for listed entities on ESG disclosures on supply chain and assurance.
Sebi has introduced BRSR Core, a sub-set of the BRSR (Business Responsibility and Sustainability Report), comprising nine Key Performance Indicators (KPIs) for several E, S and G factors that need to be assured. Under the framework, large listed companies will have to make disclosures and obtain assurance as per ‘BRSR Core’ for their value chain.
Keeping in view the relevance to the Indian market context, few new KPIs have been identified for assurance such as job creation in small towns, openness of business and gross wages paid to women. Further, for better global comparability, intensity ratios based on revenue adjusted for purchasing power parity have been included.
In addition, the Securities and Exchange Board of India (Sebi) has introduced disclosures and assurance for the value chain of listed entities, as per the BRSR Core. In the supply chain, Sebi said that ESG disclosures according to the BRSR Core for the top 250 companies on a comply-or-explain basis will start from 2024-25, with assurance beginning the following year, according to a circular.
Disclosures for the value chain will be made by the listed company as per BRSR Core as part of its annual report. In this regard, the value chain would encompass the top upstream and downstream partners of a listed entity, cumulatively comprising 75 per cent of its purchases or sales by value, respectively.
As per Sebi, listed entities will have to report the KPIs in the BRSR Core for their value chain to the extent it is attributable to their business with that value chain partner. Such reporting may be segregated for upstream and downstream partners or can be reported on an aggregate basis. Sebi also said the board of the listed entity will have to ensure that the assurance provider of the BRSR Core has the necessary expertise for undertaking reasonable assurance. Further, the listed entity would have to ensure that there is no conflict of interest with the assurance provider appointed to assure the BRSR Core. For instance, it needs to be ensured that the assurance provider or any of its associates do not sell its products or provide any non-audit related service, including consulting services, to the listed entity or its group entities
Induction cum Training Program on 13th and 14thJuly 2023 – 2pm to 5 pm – Organised by Indian Pharmacopoea Commission
NCC-MvPI, IPC is organizing 10th Induction-cum-Training Programme from July 13-14, 2023 from 2:00 pm to 5:00 pm via digital/virtual platform to educate/aware Coordinators/Deputy Coordinators of hospitals/clinical establishments those who have submitted the enrolment form under MvPI.
After the completion of the training programme, NCC-MvPI, IPC will provide a time period of 3 months to the hospitals/clinical establishments for actively participating under MvPI.
Based on the active involvement of hospitals/clinical establishments in materiovigilance, NCC-MvPI, IPC will approve the hospitals/clinical establishments as MDMC in forthcoming MvPI partners meeting.
In this connection, all Hospitals / Clinical Establlishments are invited to this training programme in order to strengthen the materiovigilance programme in your organsation. Prior registration is a must.
CME on PHARMACOLOGY – TOPIC : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES on 15th July 2023
Government of Karnataka Shri Atal Bihari Vajpayee Medical College & Research Institute, Bengaluru formerly called Bowring & Lady Curzon Medical College & Research Institute, DEPARTMENT OF PHARMACOLOGY jointly organised with NCC-MvPI, IPC & RTC-MvPI NIMHANS, Bengaluru conducting CME on 15thtJuly 2023
Topic : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES
Mode : Hybrid
Time : 9 am to 4 pm
Fee : Rs. 200
Venue: Lecture Hall 3, SABVMCRI, Bengaluru
Contact : Dr. Nishitha S B @ 9591040864
Who can register: Medical, Dental, Nursing, AHS , Paramedical, Pharmacy, AYUSH, Physiotherapy – faculty/Students, Health Department Officials & Industry Professionals
DoP releases strategy document to fine tune & implement National Medical Devices Policy
In an effort to fine tune and proceed with the implementation of the National Medical Devices Policy, 2023, launched in the month of May, the Department of Pharmaceuticals (DoP) has come out with an elaborate strategy document which emphasises on data security measures, adoption of national nomenclature for medical devices, a strategy to manage e-waste of obsolete medical devices and strengthening of technology transfer capabilities in the sector.
It would also work towards providing awareness to the innovatory community on regulator compliance, early on in the product development cycle through structured programmes using course curriculum, skill training or workshops, it said.
The NMDP, 2023 covers six broad areas of work for the promotion of the medical devices industry including regulatory streamlining, enabling infrastructures, facilitating research and development and innovation, attracting investments in the sector, human resource development and brand positioning and awareness creation.
As part of infrastructure development, the strategy document states, “”In close coordination with the ministry of environment, forest and climate changes, processes will be developed for e-waste management of obsolete medical devices”.
“The Policy strives to create an ecosystem to promote Research and Innovation in the sector under the ambit of the department’s proposed separate ‘Policy to Catalyse R&D and Innovation in the Pharma-MedTech Sector in India’”
Besides, a mechanism will be put in place to hand-hold the innovators and IP holders towards commercialisation of the products
Under the fiscal and non-fiscal measures to attract investments in the sector, it looks at incubation support for start ups in the R&D and innovation, mentorship for entrepreneurs along with skill development, such as business management, market access and commercialisation efforts for the innovation solutions developed, technology transfer mechanism for innovative solutions and relations for start-ups in compliance and regulatory regime.
Under the human resources development strategy, it envisages that since the human resources in the field of design are limited, the National Institutes of Design (NID) and private design schools will be encouraged to teach design centric courses to fill the gap, it added.
Commerce ministry authorises EPCMD to issue registration-cum-membership certificates for exporters
The Commerce Ministry has authorized the newly-established Export Promotion Council for Medical Devices (EPCMD) to issue registration-cum-membership certificates for exporters of specific medical items. These items include bandages, first-aid boxes, hot water bottles, ice bags, gloves, surgical garments, syringes, and stethoscopes.
A Registration-cum-Membership Certificate (RCMC) is required for exporters to avail benefits under the foreign trade policy, as well as customs and excise benefits
Holding the certificate can also help exporters in availing benefits with respect to customs and excise.
These items also include hot water bottles, ice bags, gloves, personal protective garments for surgical/medical use, surgical gowns and drapes, syringes, with or without needles, and stethoscopes.
The directorate general of foreign trade (DGFT) in a public notice stated that the council has been included in FTP for “issuing RCMC for specific items”.
New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.
Need for new regulations:
Despite increasing investment in the pharmaceutical sector, most drugs that cleared the animal-testing stage fail at the stage of human clinical trials.
The limitations of the conventional testing process, beginning with animals, have led an increasing number of researchers to focus on systems that do a better job of capturing the intricacies of human biology and predicting humans’ responses.
Key-highlights of the Amendment:
The amendment authorises researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.
These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies
Technologies suggested as alternatives:
To avoid animal use for clinical trials, technologies can be used effectively which includes;
Technologies developed using human cells or stem cells: These include millimetre-sized three-dimensional cellular structures that mimic specific organs of the body, called “organoids” or “mini-organs”.
‘Organ-on-a-chip’ Technology: These are AA-battery-sized chips lined with human cells connected to micro channels, to mimic blood flow inside the body.
These systems capture several aspects of human physiology, including tissue-tissue interactions and physical and chemical signals inside the body.
USING 3D Bioprinter: Bio printers are used to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’.
Since they can be built using patient-specific cells, they can also be used to personalise drug-tests.
