Current Events

Description :

The requirement for the Quality Unit review and approval of document changes is clear in 21CFR211. However, contemporary regulatory expectations for the control of change goes well beyond document change review. The expanded expectation for change control and the Quality Unit responsibilities in the change control process was introduced into the FDA regulated industries in 1996 when it became a requirement for medical devices and was part of the proposed amendments to 212CFR211. Since that Change Control has been an element of the Quality System approach found in ICH Q10 and related guidances. It is important that all individuals involved in the pharmaceutical industry understand the expectations for change control in the everyday pharmaceutical firm operations. In this webinar we will discuss the egulatdory expectations for change control and how change control fits into the pharmaceutical quality system.
Objective :
The objective of this webinar is to help individuals working in the pharmaceutical understand the regulatory requirements for change control and how change control integrates into the pharmaceutical quality system

Areas Covered in the Session :

The evolution of change control into regulatory expectations
Why an organization needs change control
How change control fits into the pharmaceutical quality system
The change control process

Who Will Benefit:

personnel at all levels of a pharmaceutical firm
Senior management
Middle management
line personnel
Quality Assurance personnel

About Speaker:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions. << less

Description :

The requirement for the Quality Unit review and approval of document changes is clear in 21CFR211. However, contemporary regulatory expectations for the control of change goes well beyond document change review. The expanded expectation for change control and the Quality Unit more >>

16th Pharmacovigilance 2018
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management"
02nd – 04th Oct 2018, Double Tree Suites By Hilton Boston, Cambridge, Massachusetts, USA
16th Pharmacovigilance 2018 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pv requirements, and to improve their organizations' compliance with pv requirements. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting Pv development.
SPONSORS:
• PRINCIPAL SPONSOR:

 Brookwood
KEY SPEAKERS:
• WILLIAM WANG, Executive Director, Clinical Safety Statistics, Merck
• TEGINDER SINGH, Senior Director Global Regulatory Affairs, Johnson & Johnson
• ALEXANDRE KIAZAND, Global Head Safety Science, AstraZeneca
• RICHARD WOLF, Head of GCSP Regions & PV Operations, CSL Behring
• MICK FOY, Group Manager, MHRA (UK)
• DEEPA ARORA, Vice President - Pharmacovigilance & Global Head- Drug Safety & Risk Management, Lupin
• KHAUDEJA BANO, Senior Medical Director Medical Affairs, Abbott
• DOUG COFFMAN, Chief of Staff/Senior Director, Strategy & Business Planning - Global Patient Safety Evaluation, Takeda Pharmaceuticals
• MATTHEW MELDORF, Senior Group Medical Director, Safety Science, Genentech
• ANAND ANANTHAKRISHNAN, Director, Pharmacovigilance Safety System Operations, Fresenius Medical Centre
• WILLIAM BLUMENTALS, Sr. Director, Pharmacoepidemiology Team Lead, Sanofi Genzyme
• PEDRO L. OYUELA, Medical Director, Global Patient Safety, Amgen
• ANNAYA BHATTACHARYA, Director Global IO Implementation Lead, Bristol-Myers Squibb
• DAVID CHONZI, Vice President- Head of Patient Safety and Pharmacovigilance, Kite Pharma, A Gilead Company
• ANKA G. EHRHARDT, Director, Clinical Research, CHDI Foundation
• DAVID HUTCHINSON, Founder, Brookwood International Academy
• SUZANNE SCHRANDT, Director, Patient Engagement, Arthritis Foundation
• MELVA T. COVINGTON, Principal, AGAPE Strategic Solutions
• SHEILA WEISS, Senior Research Leader, Evidera
• SHEETAL KHEDKAR, Senior Director, Regulatory Science, Sarah Cannon Development Innovations
• BEN LOCWIN, President, Healthcare Science Advisors
• STEPHEN F. AMATO, Faculty Director Graduate Regulatory Affairs, Market Access and Life Sciences, Northeastern University
Plus many more
KEY THEMES:
• Pharmacovigilance in the US: What comes next for the industry?
• Recent developments - legislation, policies, systems, technology, communication strategies and best practice in PV
• Optimising the overall PV ecosystem - Challenges and Opportunities
• Why does pharmacovigilance sometimes fail and where
could the fault lie?
• Pharmacovigilance and healthcare system
• Technology Impact - Cloud – Big data – Analytics – AI – Machine learning
• Updates to PSUR, PBRERs, DSUR, PASS
• Good Clinical Practices and Good Pharmacovigilance practices
• Future of outsourced phase I, II and III trials and post-marketing studies
• Data quality management and analysis – analyzing the new guidelines
• Strategies to improve clinical trials and PV
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• Patient centric approach to help improve patient safety
• Outsourcing activities - Choosing your right vendor and setting the path right
• PV Audit & inspections - preparation, implementation and lessons to be learnt
• Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
• Current regulations and guidelines - USA, EU and RoW
• The developing regulatory framework in advanced and developing markets
• Be part of a major networking opportunity
WHO SHOULD ATTEND:
CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:
Pharmacovigilance, Pharmacoepidemiology, Pharmacogenomics, Drug/Product Safety, Drug Development, Information and Clinical Data Management, Clinical Pharmacology, Clinical Safety, Periodical safety update Reports, Risk Management, Research & Development, Quality Assurance, Patient Safety, Signal Detection, Safety Surveillance, Outcomes Research, Data Analysis, Epidemiology, Medical Affairs, Regulatory Affairs and Compliance, Information technology, Sales and Marketing.
CONFERENCE REGISTERATION:
In order to register you can simply let us know your interests through Email: kavitha@virtueinsight.co.in or CALL: +44 2036120886
Conference + Workshop:
• Introductory Offer (3 delegate places for the price of 2) A huge saving of £999 - (Limited seats left)
• Super Early Discount (Valid Till 5th July 2018) : (£999 per delegate)
• Early Discount (6th July 2018 - 17th August 2018): (£1299 per delegate)
• Standard Registration (18th August 2018 Onwards): (£1499 per delegate)
• Conference Sponsor & Exhibition Stall (Booth) or a paid Speaker slots are also available
Conference Only:
• Introductory Offer (3 delegate places for the price of 2) A huge saving of £799 (Limited seats left)
• Super Early Discount (Valid Till 5th July 2018: (£799 per delegate)
• Early Discount (6th July 2018 - 17th August 2018): (£999 per delegate)
• Standard Registration (18th August 2018 Onwards): (£1299 per delegate)
• Conference Sponsor & Exhibition Stall (Booth) or a paid Speaker slots are also available
Workshop Oniy – 250
Join us at 16th Pharmacovigilance 2018 and expand your knowledge of the latest business models and strategies in the high-level conference. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.
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16th Pharmacovigilance 2018
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management"
02nd – 04th Oct 2018, Double Tree Suites By Hilton Boston, Cambridge, Massachusetts, USA
16th Pharmacovigilance 2018 will bring together top pharmaceutical, more >>

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EuroSciCon invites the participants from all over the world to attend the 3rd Edition of International Conference on Colorectal Cancer 2018, this Colorectal Cancer Conference will assemble recent researches & findings, oral talks, poster presentation and exhibition in colorectal cancer, colorectal cancer therapies and other issues in colorectal cancer research and its science from October 11-12th, 2018 in imperial Capital Zurich-Switzerland.The motive of this cancer conferences is "A scientific approach to enlighten about diagnosis and therapeutics in colorectal cancer" << less

EuroSciCon invites the participants from all over the world to attend the 3rd Edition of International Conference on Colorectal Cancer 2018, this Colorectal Cancer Conference will assemble recent researches & findings, oral talks, poster presentation and exhibition in colorectal cancer, colorectal more >>

The World Congress on Midwifery and Women’s Health invites speakers across continents to gather and exchange thought provoking and inspiring talks by sharing their knowledge so that others can apprise from it. The set theme, “New Standards of Healthcare: Caring from Cells to Souls” appeals for sharing educational, philosophical and informational lectures from eminent personalities over the globe highlighting current issues, challenges and advancements in this field. Midwifery Women’s Health Conference is going to be a unique platform to host talks for a vast field of subjects. << less

The World Congress on Midwifery and Women’s Health invites speakers across continents to gather and exchange thought provoking and inspiring talks by sharing their knowledge so that others can apprise from it. The set theme, “New Standards of Healthcare: Caring from Cells to Souls” appeals for sharing more >>

The 44th Society of Perfusion Scientists Annual Congress 2018

SCPS, or The Society of Perfusionists as it was previously known, was formed in 1974 and its main objectives are to promote the advancement of perfusion technology and to represent the interests of Clinical Perfusionists.

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Chemistry 2018 is glad to welcome all the participants, Eminent pioneers of chemistry, Professors, analysts, delegates, Students, business specialists and authorities from wherever all through the globe at "Global Chemistry Congress" on November 26-28, 2018 at Rome, Italy, which consolidates keynote sessions, Oral Sessions, Symposia and exhibitors.

Chemistry 2018 is a global platform and discuss about the different branches of chemistry, Organic Chemistry & Inorganic Chemistry, Analytical Chemistry, Materials Chemistry, Green Chemistry, Medical Biochemistry, Physical Chemistry, Theoretical Chemistry. Chemistry 2018 would also discuss various topics related to chemistry like Petro Chemistry and Petrochemicals, Nuclear Chemistry, Polymer Chemistry, Pharmacognosy & Phytochemistry, Medicinal & Pharmaceutical Chemistry, Industrial Chemistry and Environmental Chemistry.

Rome, Italy today is a standout amongst the most critical vacationer goals of the world, because of the boundless Villas and museums.

We cordially invite all of you to participate in Chemistry 2018! << less

Chemistry 2018 is glad to welcome all the participants, Eminent pioneers of chemistry, Professors, analysts, delegates, Students, business specialists and authorities from wherever all through the globe at "Global Chemistry Congress" on November 26-28, 2018 at Rome, Italy, which consolidates keynote more >>

The 11th Annual Cloud & Big Data Analytics 2018 focuses on the emerging area of cloud, inspired by some latest advances that concern the infrastructure, operations, and available services through the global network. The conference is nevertheless not about the union of these two (already broad) fields, but about cloud where we are also interested in how services science can provide theory, methods and techniques to design, analyse, manage, market and study various aspects of cloud computing.

The data industry is growing fast, and Virtue Insight’s Cloud Conference has grown right along with it. We've added new sessions and tracks to reflect challenges that have emerged in the data field including Data Security, Data Analytics, AI, Hybrid Cloud, Machine Learning, Digital Transformation and much more.

We need to take a closer look, discerning what emerging enterprise technologies are and how they can catalyse creativity and produce a competitive advantage. This emerging facilitation and way of utilizing services through IT is what we are referring to as Cloud Computing.
<< less

The 11th Annual Cloud & Big Data Analytics 2018 focuses on the emerging area of cloud, inspired by some latest advances that concern the infrastructure, operations, and available services through the global network. The conference is nevertheless not about the union of these two (already broad) fields, more >>

11th Annual Cloud & Big Data Analytics 2018
29th November 2018, Sterlings Mac (Matthan Hotel), Bangalore, India
“Convergence of two key technologies”
Virtue Insight is happy to invite you to 11th Annual Cloud & Big Data Analytics 2018 to attend as a sponsor/delegate to be held on 29th November 2018, Sterlings Mac (Matthan Hotel), Bangalore, India.The 11th Annual Cloud & Big Data Analytics 2018 focuses on the emerging area of cloud, inspired by some latest advances that concern the infrastructure, operations, and available services through the global network. The conference is nevertheless not about the union of these two (already broad) fields, but about cloud where we are also interested in how services science can provide theory, methods and techniques to design, analyse, manage, market and study various aspects of cloud computing.The data industry is growing fast, and Virtue Insight’s Cloud Conference has grown right along with it. We've added new sessions and tracks to reflect challenges that have emerged in the data field including Data Security, Data Analytics, AI, Hybrid Cloud, Machine Learning, Digital Transformation and much more.
KEY SPEAKERS:
• ANNIE MATHEW, Sr. Director, Evangelism, Microsoft
• LUX RAO, Director & Leader - Digital Transformation, Cisco
• BAPIRAJU NANDURY, Program Director Cloud and Cognitive Software, IBM
• SHOURYA ROY, Head and VP, American Express Big Data Labs
• RAMESH CHANDRA PATHAK, Associate Director, Chief Architect Public Cloud, IBM
• KRISHNA MARKANDE, Associate Vice President, Principal Technology Architect, Infosys
• DEBAL CHAKRABORTY, AVP – Analytics, Vodafone Shared Services
• VIBHAKAR BHUSHAN, Member Governing Board, Cloud Computing Innovation Council Of India
• RAVINDER PAL SINGH, Director - Solutions Business Development, Dell EMC
• ANUP REGHUNATHAN, Senior Engineering Manager, Microsoft
• CHIRANJIV ROY, Principal Data Scientist, Mercedes-Benz Research and Development
• MATHANGI SRI, Vice President Next Gen Solutions, Citi
• GANAPATHY V, Business Lead - Data Science and AI Group, Senior Director, Philips
• JOPHY VARGHESE, APAC Head - Strategic SIs & Alliances, Verizon
• PETHURU RAJ, Chief Architect and Vice-President, Reliance Jio Cloud
• UTTAM KUMAR, Head - New Technologies Innovation & Incubation, Aircel
• SUNDARA RAMALINGAM NAGALINGAM, Head - Deep Learning Practice, NVIDIA Graphics
• SATISH VISWANATHAN, Chief Product Officer, NxtGen Datacenter & Cloud Technologies
• GOUTHAM UPADHYAYA, Cloud Solutions Architect, Alibaba Cloud International
• MUKESH JAIN, CTO (Former VP & Head-Big Data Analytics, Jio), VFS Global
• VISWANADH AKELLA, Co-Founder & CEO, SimplyFI SoftTech
• MARUTISH VARANASI, Head Big Data Analytics & AI, Marvelogic Consultancy
KEY THEMES DISCUSSED:-
• IoT and Big Data: The profitable advantage
• Case studies of how large corporations are implementing IoT
• Driving industry innovation with hybrid cloud
• Achieving API development and portal managed services in cloud
• Choosing the right cloud services and tools
• Transforming the culture of business and science with the help of big data
• Cloud Security: Regulatory compliance and adaption for DevOps
• Addressing the new liabilities of Sensitive Data
• Machine learning and data analytics
• Exploring benefits of using cloud for data analytics and machine learning
• Cloud, Edge and Fog Computing - Developing ways for IoT data
• Optimum way to build, evaluate and operationalize artificial intelligence
• Building an adaptable and resilient digital environment
WHO SHOULD ATTEND:-
All job titles starting from the top management from the following categories:
CISOs, Security Consultants, CTOs, Device Manufacturers, Sensors and Embedded Systems Companies, Systems Integrators, Enterprise Product management and development, Service Providers – Fixed, Wireless and Satellite, Developers, Content and Contact Managers, Technology, Product, Strategy, Storage, Business Analysts, Database/Data Center, Hosting, Training, System and Network Integrators, Data Center Managers, Telecoms and Tech, Compliance and Policy, Network Administrators
CONFERENCE BOOKING DETAILS:-
E-mail : kavitha@virtueinsight.co.in or TEL: +91 44 24762472
• Early Bird Discounted Price(Ends on 16th October 2018) 1 Delegate Pass - (INR 6,000 + GST (18%) per delegate)
• Standard Price (17th October 2018 Onwards)– 1 or 2 Delegates - (INR 7,000 + GST (18%) per delegate
• Group Discounts: 3 or 4 Delegates - (INR 6,500 + GST (18%) per delegate)
• Group Discounts: 5 and above Delegates - (INR 6,000 + GST (18%) per delegate)
• Spot Registration: 1 Delegate Pass (INR 8,000 + GST (18%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, Exhibition Stall (Booth) or a paid Speaker Slot are also available.
In order to register you can simply e-mail me your invoice details in the below mentioned format; E-mail- Kavitha@virtueinsight.co.in
• Name:
• GST Number (If Applicable):
• Company Name & Address:
• Job Position:
• Contact Number:
Get more from the event, with a broader scope bringing the whole communications value chain together, Enjoy and make the best out of our dedicated networking time, meet the leading international vendors. Expand your knowledge of the latest business models and strategies in the high-level conference, showcasing the products of tomorrow in the co-located exhibition.
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11th Annual Cloud & Big Data Analytics 2018
29th November 2018, Sterlings Mac (Matthan Hotel), Bangalore, India
“Convergence of two key technologies”
Virtue Insight is happy to invite you to 11th Annual Cloud & Big Data Analytics 2018 to attend as a sponsor/delegate to be held on 29th November more >>

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The 2019 Spring Meeting will be held at Manchester University on 15-17 April. The local organisers are Dr Ilaria Russo and Prof Kathryn Else, working with Prof Geoff Hide, Prof Guy Caljon, Prof Ron Hokke and Dr Erinma Ochu.

Keynote speakers include: Prof Joanne Webster (Royal Veterinary College) and Prof Patricia Wright (Stoneybrook, USA) for One Health and Prof Andy Miah (Salford) for Science Communication.

Dateline:

Abstract submission : open Closes March 2019
Ticketing: opens October 2018
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The 2019 Spring Meeting will be held at Manchester University on 15-17 April. The local organisers are Dr Ilaria Russo and Prof Kathryn Else, working with Prof Geoff Hide, Prof Guy Caljon, Prof Ron Hokke and Dr Erinma Ochu.

Keynote speakers include: Prof Joanne Webster (Royal Veterinary College) more >>

The EE & RE exhibition is a platform for many local and foreign companies to showcase their eco-friendly solutions for energy production and consumption. The event has the format “exhibition-conference” and is open to visitors from the sectors of automation, energy, construction, engineering, different industry branches, representatives of municipalities and government administration, HVAC, lighting, transport and logistics, etc.

The program for the parallel conference will become available on the event website by the end of the year.

Presented solutions: • Energy efficient heating and cooling systems - heat pumps, biomass boilers • Cogeneration plants • Energy from waste • Biogas plants for the food industry and agriculture, waste-water treatment plants • Energy management, audit and consulting • LED lighting • Photovoltaic panels, hybrid systems for autonomous power supply • Equipment for heating, air-conditioning and gas installations • Systems for the production of pellets from wood, straw, sunflower husks, municipal/household waste, etc. << less

The EE & RE exhibition is a platform for many local and foreign companies to showcase their eco-friendly solutions for energy production and consumption. The event has the format “exhibition-conference” and is open to visitors from the sectors of automation, energy, construction, engineering, different more >>

The Save the Planet exhibition showcases local and foreign companies, who offer products and solutions for waste collection, treatment and utilization. A conference on the same topics will take place parallel to the exhibition. The event is open to representatives of municipalities and government administration, ecologists, investors, managers of companies from the sectors recycling, waste management, agriculture, food and packaging, etc.

The program for the parallel conference will become available on the event website by the end of the year.

Exhibitors profile: Waste management; Waste collection; Transport vehicles and technologies; Waste treatment equipment; Medical waste treatment and disposal; Landfill; Waste-to-Energy; Thermal treatment - by direct combustion; Recycling; Plants for recycling; Services
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The Save the Planet exhibition showcases local and foreign companies, who offer products and solutions for waste collection, treatment and utilization. A conference on the same topics will take place parallel to the exhibition. The event is open to representatives of municipalities and government administration, more >>

Smart Cities aims to popularize modern technologies and practices that can turn our cities into more eco-friendly and effective systems. It is a meeting point for solution providers and consumers. The parallel conference offers a chance to obtain information on current trends, legislation and perspectives. Among the event participants are companies offering solutions for passive houses, public transport innovations, energy efficient lighting, software for smart buildings and industry, etc.

The program for the parallel conference will become available on the event website by the end of the year.

Exhibitors Smart Cities:

• Energy Efficiency in Smart Cities and Smart Buildings;
• Sustainable City Mobility;
• Information and Communication Technologies (ICT) for Smart Cities;
• Smart Energy;
• Sustainable City Environment
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Smart Cities aims to popularize modern technologies and practices that can turn our cities into more eco-friendly and effective systems. It is a meeting point for solution providers and consumers. The parallel conference offers a chance to obtain information on current trends, legislation and perspectives. more >>