11th Pharmacovigilance 2016, 1st Dec 2016, Kohinoor Continental Hotel, Mumbai, India
11th Pharmacovigilance 2016
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”
1st December 2016, Kohinoor Continental Hotel, Mumbai, India
After the successful journey of a series of 10 Pharmacovigilance conferences, Virtue Insight is proud to announce its 11th Pharmacovigilance 2016 in India. It is our great pleasure to invite you to the 11th Pharmacovigilance 2016, in Mumbai – India on 1st of December 2016. We have a wide range of scientific topics with something for everyone.
The past is reflected in a session about Indian traditional medicine and the future is discussed under Big Data analytics and in the research of our young scientists. However, we must live and act in the present and debate pressing challenges that face us today in pharmacovigilance (PV). The rates for medication errors are too high. We still struggle to communicate risk well. With the welcome drive towards transparency and respecting human rights, legal and ethical issues in PV have come to the fore. Society’s research enterprise as a whole needs to become far more aware of the commercial reality that PV underpins safety, with its intimate links to innovation, so that safety and must be intrinsically built into successful development and marketing. With governments round the world struggling to curb healthcare costs, the importance of integrating PV into National Health Programmes has never been more important.
It gives me great pleasure in welcoming all of you to the virtue insight’s 11th Pharmacovigilance 2016. I wish and pray that all our efforts will be beneficial to our industries and to our country at large.
pic KANCHI SHAH, VIRTUEINSIGHT
KEY SPEAKERS INCLUDE
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Plus Many More..
PEOPLE YOU GET TO MEET
Vice Presidents, Directors, CRO’s, Heads and Managers of:
Pharmacovigilance Strategy, Drug Safety/Risk Management, Information and Clinical Data Management, Clinical Research, Research & Development, Product Safety/Assurance Assessment, Patient Safety & Outcomes Research & Data Analysis, Epidemiology project management, Regulatory Affairs and Compliance, Sales & Marketing, Biotech manufacturers
FROM VARIOUS
Pharmaceutical organizations, Generic pharmaceutical companies, Contract research organizations, Patient recruitment companies, Government- Department of health, Non-profit organizations/ Association, Consultants
This event also serves as a platform for networking opportunities in the relevant field , wherein you get to meet and broaden your contacts to develop your business. We also have sponsorship opportunities available for the event which gives you an opportunity to speak/exhibit and create brand awareness. Or you could even attend the event as a delegate and get a better insight of the updates and the increasing challenges in the industry . So hurry now and be a part of this massive event.
GLIMPSES OF MY( DR ANTHONY) INTERACTION
with Fen Castro of VirtueInsight, Director , and his team , , —thanks for inviting me to 9th Biosimilars Congregation 2016., Lalit hotel, Mumbai, India, 22nd Sept 2016 — with Fen Castro, Kanchi Shahand Virtue Insight at The Lalit Hotel.
CONFERENCE BOOKING DETAILS
Online Registration http://www.bookmytrainings. |
Early Bird Discount Price – 1 Delegate Pass (INR 6,000 + Tax (15%) – Book and Pay before 17th October 2016 to avail this price |
Standard Price (From 18th October 2016) – 1 Delegate Pass – (INR 7,000 + Tax (15%) |
Group Discounts (Applicable for 3 or 4) – 1 Delegate Pass – (INR 6,500 + Tax (15%) |
Group Discounts (Applicable for 5 or more) – 1 Delegate Pass – (INR 6,000 + Tax (15%) |
Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, Exhibition Stall (Booth) or a paid Speaker Slot, you can simply call or email your interest and queries to TEL: +91 44 64614333, or sponsor@virtueinsight.com |
REGISTRATION PROCESS
In order to register simply email the below mentioned details to delegate@virtueinsight.com
- Company Name & Address
- Attendee Name/Names
- Job Title
- Contact Number
We also have some sponsorship opportunities available for the event, which gives you an opportunity to speak/exhibit, and create brand awareness. In addition, the networking opportunities in focused and relevant industry gathering provide the personal contact necessary for business development efforts.
In case you or any of your colleagues might be interested in participating in the same, please let us know and we will be happy to call you and help you with the registration.
SEE BROCHURE
ALLOW BROCHURE TO LOAD
Thank you for your time and consideration.
Fen Castro
Head – Productions
Virtue Insight
Tel (India) – + 91 44 64614333
Mobile (India) – + 91 9003 26 0693
Tel (UK) – + 44 2036120886
////////////11th Pharmacovigilance, 2016, 1st Dec, 2016, Kohinoor Continental Hotel, Mumbai, India, Conference, fen castro
ECA Task Force will publish Draft Data Integrity Guideline at Conference in October
Data Integrity has become one of the most frequently observed GMP deviations at FDA and EU Inspections. For that reason the ECA Foundation decided to set up a Task Force on Data Integrity in December 2015 – with the goal to provide Guidance for the implementation in practice. Read more about the ECA Guidance on Data Integrity.
http://www.gmp-compliance.org/eca_mitt_05545_15488_n.html
Data Integrity has become one of the most frequently observed GMP deviations at FDA and EU Inspections. This is why the topic is currently in the centre of attention of both regulators and industry. And for that reason the ECA Foundation decided to set up a Task Force on Data Integrity in December 2015 – with the goal to provide Guidance for the implementation in practice.
The ECA Task Force will be comprised of members from both the IT Compliance Group and the Analytical QC Group. Current Members are:
– Dr. Wolfgang Schumacher, Hoffmann-La Roche, Switzerland
– Dr. Chris Burgess, Qualified Person and Consultant, UK
– Dr. Bob McDowall, Consultant, UK
– Ms. Margarita Sabater, ALK-Abelló A/S, Denmark
The Task Force decided to develop a Guidance entitled: “Data Governance and Data Integrity for GMP Regulated Facilities“. The ECA Guidance Document will cover – among others – the Roles and Responsibilities of Corporate and Senior Management in Data Governance as well as the necessary Policies, Procedures and Processes. Further information is provided on establishing criteria for Data Integrity and security of records based on ALCOA+Principles and on Auditing for Data Integrity and security of records.
The Guide will contain a Glossary as well as some illustrative appendices for further information.
Margarita Sabater, Member of the ECA Task Force, will present the Draft Version of the ECA Data Integrity Guidance Document during the Lab Data Integrity Conference on 20-21 October 2016 in Vienna, Austria. Every participant will receive a copy of the Draft Document – and is also invited to provide feedback to the Guidance Document.
//////ECA Task Force, Draft Data Integrity Guideline, Conference
WEBSITE http://www.scientificupdate.co.uk/
SCIENTIFIC UPDATE HAS A REPUTATION FOR ITS HIGH QUALITY EVENTS, BOTH FOR THE SCIENTIFIC CONTENT AND ALSO FOR THE EFFICIENCY OF ITS ORGANISATION. KEEP YOUR SKILLS UP TO DATE AND INVEST IN YOUR CONTINUING PERSONAL PROFESSIONAL DEVELOPMENT.
TRAINING COURSE 2-3 DEC 2014
Process Development for Low Cost Manufacturing
When:02.12.2014 – 03.12.2014
Tutors:
Where: National Chemical Laboratory – Pune, India
Brochure:View Brochure
Register http://scientificupdate.co.uk/training/scheduled-training-courses.html
DESCRIPTION
Chemical process research and development is recognised as a key function during the commercialisation of a new product particularly in the generic and contract manufacturing arms of the chemical, agrochemical and pharmaceutical industries.
The synthesis and individual processes must be economic, safe and must generate product that meets the necessary quality requirements.
This 2-day course presented by highly experienced process chemists will concentrate on the development and optimisation of efficient processes to target molecules with an emphasis on raw material cost, solvent choice, yield improvement, process efficiency and work up, and waste minimisation.
Process robustness testing and reaction optimisation via stastical methods will also be covered.
A discussion of patent issues and areas where engineering and technology can help reduce operating costs.
The use of engineering and technology solutions to reduce costs will be discussed and throughout the course the emphasis will be on minimising costs and maximising returns.
Conference 4-5 DEC 2014
TITLE . Organic Process Research & Development – India
Subtitle:The 32nd International Conference and Exhibition
When:04.12.2014 – 05.12.2014
Where:National Chemical Laboratory – Pune, India
Brochure:View Brochure
Register..http://scientificupdate.co.uk/conferences/conferences-and-workshops.html
for
- Process Research & Development Chemists
- Chemical Engineers in Industry
- Heads of Departments & Team Leaders
Benefits
- Invest in yourself: keeping up to date on current developments and future trends could mean greater job security.
- Learn from a wide range of industrial case studies given by hand-picked industrial speakers.
- Take home relevant ideas and information that are directly applicable to your own work with the full proceedings and a CD of the talks.
- Save time. Our intensive, commercial-free programme means less time away from work.
- Meet and network with the key people in the industry in a relaxed and informal atmosphere.
Do you want to improve efficiency and innovation in your synthetic route design, development and optimisation?
The efficient conversion of a chemical process into a process for manufacture on tonnage scale has always been of importance in the chemical and pharmaceutical industries. However, in the current economic and regulatory climate, it has become increasingly vital and challenging to do so efficiently. Indeed, it has never been so important to keep up to date with the latest developments in this dynamic field.
At this Organic Process Research & Development Conference, you will hear detailed presentations and case studies from top international chemists. The hand-picked programme of speakers has been put together specifically for an industrial audience. They will discuss the latest issues relating to synthetic route design, development and optimisation in the pharmaceutical, fine chemical and allied fields. Unlike other conferences, practically all our speakers are experts from industry, which means the ideas and information you take home will be directly applicable to your own work.
The smaller numbers at our conferences create a more intimate atmosphere. You will enjoy plenty of opportunities to meet and network with speakers and fellow attendees during the reception, sit-down lunches and extended coffee breaks in a relaxed and informal environment. Together, you can explore the different strategies and tactics evolving to meet today’s challenges.
This is held in Pune, close proximity to Mumbai city, very convenient to stay and travel to either in Pune or Mumbai. I feel this should be an opportunity to be grabbed before the conference is full and having no room
Hurry up rush
References
1 http://newdrugapprovals.org/scientificupdate-uk-on-a-roll/
2 http://scientificupdate.co.uk/conferences/conferences-and-workshops.html
3 http://en.wikipedia.org/wiki/Pune
PROFILES
Will Watson
Dr Will Watson gained his PhD in Organic Chemistry from the University of Leeds in 1980. He joined the BP Research Centre at Sunbury-on-Thames and spent five and a half years working as a research chemist on a variety of topics including catalytic dewaxing, residue upgrading, synthesis of novel oxygenates for use as gasoline supplements, surfactants for use as gasoline detergent additives and non-linear optical compounds.
In 1986 he joined Lancaster Synthesis and during the next 7 years he was responsible for laboratory scale production and process research and development to support Lancaster’s catalogue, semi-bulk and custom synthesis businesses.
In 1993 he was appointed to the position of Technical Director, responsible for all Production (Laboratory and Pilot Plant scale), Process Research and Development, Engineering and Quality Control. He helped set up and run the Lancaster Laboratories near Chennai, India and had technical responsibility for the former PCR laboratories at Gainesville, Florida.
He joined Scientific Update as Technical Director in May 2000. He has revised and rewritten the ‘Chemical Development and Scale Up in the Fine Chemical & Pharmaceutical Industries’ course and gives this course regularly around the world. He has been instrumental in setting up and developing new courses such as ‘Interfacing Chemistry with Patents’ and ‘Making and Using Fluoroorganic Molecules’.
He is also involved in an advisory capacity in setting up conferences and in the running of the events. He is active in the consultancy side of the business and sits on the Scientific Advisory Boards of various companies.
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John Knight
Dr John Knight gained a first class honours degree in chemistry at the University of Southampton, UK. John remained at Southampton to study for his PhD in synthetic methodology utilizing radical cyclisation and dipolar cyloaddition chemistry.
After gaining his PhD, John moved to Columbia University, New York, USA where he worked as a NATO Postdoctoral Fellow with Professor Gilbert Stork. John returned to the UK in 1987 joining Glaxo Group Research (now GSK) as a medicinal chemist, where he remained for 4 years before moving to the process research and development department at Glaxo, where he remained for a further 3½ years.
During his time at Glaxo, John worked on a number of projects and gained considerable plant experience (pilot and manufacturing). In 1994 John moved to Oxford Asymmetry (later changing its name to Evotec and most recently to Aptuit) when it had just 25 staff. John’s major role when first at Oxford Asymmetry was to work with a consultant project manager to design, build and commission a small pilot plant, whilst in parallel developing the chemistry PRD effort at Oxford Asymmetry.
The plant was fully operational within 18 months, operating to a 24h/7d shift pattern. John continued to run the pilot plant for a further 3 years, during which time he had considerable input into the design of a second plant, which was completed and commissioned in 2000. After an 18-month period at a small pharmaceutical company, John returned to Oxford in 2000 (by now called Evotec) to head the PRD department. John remained in this position for 6.5 years, during which time he assisted in its expansion, established a team to perform polymorph and salt screening studies and established and maintained high standards of development expertise across the department.
John has managed the chemical development and transfer of numerous NCE’s into the plant for clients and been involved in process validations. He joined Scientific Update in January 2008 as Scientific Director.
Pune images
From top:1 Fergusson College, 2 Mahatma Gandhi Road, Shaniwarwada 3 the HSBC Global Technology India Headquarters, and the 4National War Memorial Southern Command
NCL PUNE
The National Chemical Laboratory is located in the state of Maharashtra in India. Maharashtra state is the largest contributor to India’s GDP. The National Chemical Laboratory is located in Pune city, and is the cultural capital of Maharashtra. Pune city is second only to Mumbai (the business capital of India) in size and industrial strength. Pune points of interest include: The tourist places in Pune include: Lal Deval Synagogue, Bund Garden, Osho Ashram, Shindyanchi Chhatri and Pataleshwar Cave Temple.
MAKE IN INDIA
http://makeinindia.com/sector/pharmaceuticals/
Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL
KEYWORDS
JOHN KNIGHT, WILL WATSON, SCIENTIFIC UPDATE, PROCESS, COURSE, CONFERENCE, INDIA, PUNE, PROCESS DEVELOPMENT, LOW COST, MANUFACTURING, SCALEUP