Implementation of Section 42(a) of Pharmacy Act 1947 and Rules 65 of Drugs and Cosmetics Act 1945
Drugs Controller General of India has issued a letter to all States / UTs Drug Controllers and Pharmacy Council of India on strict Implementation of Section 42(a) of Pharmacy Act 1947 and Rules 65 of D&C Act 1945 on the following:
To ensure that Pharmacists are physically present in the retail pharmacies / medical stores and that medicines are sold / dispensed under their direct supervision
To ensure that no prescription medicine is sold / dispensed from the retail medicine shop without a proper and valid prescription
Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices.
LEARNING OBJECTIVE
Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices
COURSE AGENDA
Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
Classification of Medical Devices
Basic Requirements
Content Requirements for Technical Documentation
Validity of Conformity Assessment and Certification, Transition Periods
Requirements for Manufacturers, Importers, Distributors and Service Partners
TARGET AUDIENCE
Medical device manufacturers
Consultants
Regulatory Affairs Specialists
Expert advisors in medical devices regulatory affairs
Working biomedical engineers / medical device professionals
Pursuing Students are also eligible
Duration: 2 Days (31st March & 1st April)
Location: Kalam Convention Center, AMTZ Campus, Vizag
Last Date For Registration: 25th March 2023 ➖➖➖➖➖➖➖➖ For more information, please contact Mr. Nitturi Naresh Kumar Mobile: +91-8897330990 WhatsApp Link: https://wa.me/918897330990 trainings@amtz.in
Webinar on Understanding Technical Regulations and Standards
Healthcare services rely on a number of products – from drugs to medical devices to food to electronic items. Many of these items not only need to be of high quality but also safe to use.
Since many products have health and safety implications, they are or should be regulated while others may not need to be regulated but quality needs to be assured.It is therefore necessary for healthcare industry to understand the world of what are called technical regulations and standards, how it should go about procurement of products it needs and what kind of certificates it should rely on
CAHO is hosting a webinar on the topic Understanding Technical Regulations and Standards by Mr.Anil Jauhri , (Former CEO,National Accreditation Board for Certification Bodies (NABCB)) on 23rd March 2023 between 4.00 to 5.30 pm.
Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region from 27th Mar– 07th April, 2023
SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Indonesia, Philippines, Vietnam & Thailand from 27th March to 07th April, 2023 covering following sectors which have demand in ASEAN region:
➢ Accounting and Auditing Services
➢ Educational Services
➢ Healthcare Services
➢ Architectural, Construction & Related Engineering, Environmental Services
➢ KPO/ ITO Services
➢ Logistics Services
➢ Tourism Services
➢ Entertainment Services
➢ Other Professional services
Benefits you may get while participating at BSM to ASEAN region.
• Focused pre scheduled B2B meetings in each country
• Understand the market potential from experts in ASEAN region.
• Networking Opportunities with potential buyers in ASEAN region.
• Generate business leads and sign MOUs for collaborations.
• Meetings with relevant government and related stakeholders.
SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores (should not be zero) and who have completed one year of membership with SEPC will be eligible for assistance under new MAI scheme up to a maximum of Rs. 75,000/- towards economy class air fare, subject to terms and conditions of new MAI scheme and approval by the Ministry of Commerce & Industry
Andhra Chamber – Business Delegation to Vietnam Expo April 2023
Andhra Chamber of Commerce has been organising Business Delegations to various countries for the members to explore export / business opportunities. Due to Covid 19 Pandemic, we could not organise the delegation in the last three years.
Vietnam is one of the fast-growing countries in Asia, even worldwide and now since the travel industry has also opened up, the Chamber is planning for a Business Delegation to Vietnam.
The Vietnam Expo happens every year and this year it is happening in the first week of April 2023. The Expo targets many sectors like Agricultural products, Food & Beverage, Machinery & Supporting industries, Digital technology & E-commerce; Electric & Electronics; Home Living, Trade promotion; Logistics & services etc.,
The details of the delegation along with the Registration form are enclosed and we invite you to be part of this Delegation to expand your business.
Last date of Registration is extended to 04th March 2023. Please fill up and send the registration form to enable us to enroll you for the Business Delegation to Vietnam.
For any further clarifications, please feel free to contact:
Ms.R.Vijayalakshmi Secretary General, Andhra Chamber of Commerce, “Velagapudi Ramakrishna Bldg.” No. 23, Third Cross Street, West CIT Nagar, Nandanam, Chennai-600035. Phone: 24315278/79 Email: andhrachamber1@gmail.com Web: http://www.andhrachamber.com
ISO 45002:2023 Occupational health and safety management systems — General guidelines for the implementation of ISO 45001:2018
As we all know, an organization is responsible for the occupational health and safety (OH&S) of its workers. This responsibility includes promoting and protecting their physical and mental health and for taking steps to protect others who may be affected by its activities. This is best achieved through an OH&S management system.
ISO 45002’s main goal is to instruct businesses on how to implement one of these systems within their workplace.
In short, this document gives guidance on the establishment, implementation, maintenance, and continual improvement of an OH&S management system that can help organizations conform to ISO 45001.
In addition, for illustration, most of the clauses in ISO 45002:2023 include real life examples of how different types of organization have implemented the requirements.
The OH&S management system approach that ISO 45002 addresses is founded on the concept of Plan-Do-Check-Act (PDCA). It can be applied to an OH&S management system and to each of its individual elements, as follows:
Plan: determine and assess OH&S risks, OH&S opportunities and other risks and other opportunities that can influence the intended outcomes of the OH&S management system, establish OH&S objectives and processes necessary to deliver results in accordance with the organization’s OH&S policy;
Do: implement the processes as planned;
Check: monitor and measure activities and processes with regard to the OH&S policy and OH&S objectives, and report the results;
Act: take actions to continually improve the OH&S performance to achieve the intended outcomes.
The PDCA concept outlined above is an iterative process used by organizations to achieve continual improvement. This is intended to help companies implement the ISO 45001 standards effectively and to routinely maintain them as their workplace evolves
Good Clinical Laboratory Practices (GCLP)Workshop on International Standards ISO 15189:2022 from 23rd – 25th March 2023
GCLP outline the basic principles and procedures to be followed by clinical/diagnostic laboratories involved in patient care or clinical research so as to provide highly reliable, reproducible and auditable results, which contribute to good patient care and promote a positive attitude from a patient’s perspective.
This GCLP workshop is designed to offer comprehensive guidance for those who are implementing GCLP/ISO 15189:2022 in their medical laboratories and a special session on Quality System and QA/QC in Molecularbiology Laboratory Testing included in this workshop
Only those from accredited (NABL/NABH) medical laboratories or preparing for accreditation or planning to take up a career in medical laboratory accreditation with ISO 15189:2012/2022 and Clinical Research Organization (CRO)’s laboratories (human clinical trials), are encouraged to participate in this workshop
Learning Objectives:
Basic principles of the GCLP and their relation to patient care services or clinical research.
Implementing GCLP essentials to establish a quality system and its maintenance.
Gaps between ISO 15189:2012 and ISO 15189:2022, and implementing new standards
Workshop Scope:
Overview and essentials of ISO 15189:2012.
Overview and essentials of new standard – ISO 15189:2022.
Overview and essentials of NABL-112 guidelines document.
Overview and essentials of ICMR-GCLP 2021 guidelines.
Special reference to the following key components: o Quality System Essentials (QSEs). o Establishment, management and monitoring of quality system. o Quality indicators and continual improvement. o Issues with EQAS/PT, Issues with facility operation. o Internal Quality Audit (IQA) – common NCs and its closures. o Lab accreditation associated challenges and overcoming the challenges. o Biosafety and infection control. o Quality system and basic requirements in Molecularbiology Laboratory Testing/Assays – International standard. Workshop activities include didactic lectures, interactive sessions, group discussions/exercises and case studies. The faculties from national and international settings will facilitate the program.
Registration: The participants can register for the program by paying Rs. 3,500/- and the payment can be done by scanning via net-banking or GooglePay to the following bank account: Account No. 1248135000009037, Account Name: SDC Microbiology CME, Bank: Karur Vysya Bank, IFSC Code: KVBL0001248, Branch: PH Road, Chennai-600077
The workshop is restricted to 60 slots and the registration will be done on “first come-first served basis”. For online registration, the following link has to be used: https://forms.gle/yASYBXXqKnp7NmdN8. Out station participants need to book accommodation on their own
Venue: Decennial Hall, Saveetha Dental College and Hospitals Campus, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077.
Contact: Dr. Pachamuthu Balakrishnan, Department of Microbiology, Centre for Infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077. WhatsApp/Mobile: 7667444221, Email: GCLPSAVEETHA@gmail.com
Medical Education and Learning Point (MELAP) is conducting the following Training programs in Chennai
4 days Onsite Training program on IA&QMS as per ISO 15189:2022 standard
Medical Education and Learning Point (MELAP) in collaboration with Dept of Biochemistry – Madras Medical College ( MMC ) is conducting 4 Day IA & QMS / QC training program as per the New version of standard ISO 15189 : 2022. This course is Accredited by NBQP, Division of QCI
Program Details are given below:
Date & Time : 27th – 30th March 2023 9.30 am to 4.00 pm
Venue : Madras Medical college – Chennai
Regn Fee : For Doctors / Senior Resident – Rs.11000 (incl of tax)
For Technical staff / PG Students – Rs.9000 (incl of tax)
Onsite 2 day Refresher course as per ISO 15189:2022 Standard for those who have already done 2012 version (Accredited by NBQP, Division of QCI)
Medical Education and Learning Point (MELAP) in collaboration with Department of Regenerative Medicine & Research, Govt Stanley Hospital Chennai is conducting a 2 day refresher course as per ISO 15189:2022 Standard
Program details are given below
Date : 24th & 25th March2023
Venue : Department of Regenerative Medicine & Research, Govt Stanley
NMC Mandate Enrolment of Medical Colleges as ADR monitoring centers under PvPI
Aiming to uplift regulatory standards for the overall collection, analysis and monitoring of Adverse Drug Reactions (ADRs) from the Public, National Medical Commission (NMC) has directed all medical colleges, standalone PG Institutions to enrol themselves as Adverse Drug Reaction Monitoring Centers with the Indian Pharmacopoeia Commission (IPC) under the Pharmacovigilance Program of India (PvPI) at the earliest.
Indian Pharmacopoeia is functioning as the National Co-ordination Centre, Pharmacovigilance Programme of India to collect, analyse and monitor the adverse drug reactions from the Indian population to promote Patient Safety and Safeguard the health of patients by ensuring that the benefits of the use of medicines outweigh the risk associated with its use
The collected ADRs data is a significant source of evidence of recommendations of regulatory interventions regarding the safety of medicines to the Central Drugs Standard Control Organisation (CDSCO)
In order to achieve the above objective, IPC has so far enrolled 652 Adverse Drug Monitoring Centres (AMCs).
In the 22 nd Meeting of the Governing Body of India Pharmacopoeia Commission held on 14.10.2022 under the chairmanship of the Secretary (HFW) it has been decided that all Medical colleges/ hospitals under the National Medical Commission should also be enrolled as AMCs with IPC.
Accordingly, all Medical colleges/hospitals under the National Medical Commission are directed to get themselves enrolled with Indian Pharmacopoeia Commission (IPC) as AMCs at the earliest.
Webinar on Electrical Safety in Hospitals and Medical Locations (Part – 2)
The webinar will explain about the safety measures to be adopted in Hospitals and Medical locations to get safety of patients, doctors and nurses working in medical locations and fire due to short circuit.
The webinar is specially designed for Bio Medical Engineers and working professionals in Hospitals.
Dr. Vijay Agarwal, President CAHO will make the opening remarks followed by technical sessions by CAPE Engineers. The program is hosted by Mr. K P Dominic, B&G.
Date and Time of the program : 21 Jan 2023 11 Am onwards
