|By PR Newswire||
|March 13, 2014 07:00 PM EDT||
DUBLIN, March 13, 2014 /PRNewswire/ --
Research and Markets (http://www.researchandmarkets.com/research/drlfwg/new_eu) have announced the addition of the "New EU Pharmacovigilance Legislation - The Complete Picture (Course, London)" conference to their offering.
(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )
The New EU Pharmacovigilance Legislation - The Complete Picture Course will be held on the 24th & 25th March 2014 at the Rembrandt Hotel, London
The 15 modules concerning Pharmacovigilance are a major departure in terms of the Pharmacovigilance conducted over the last 5 years in Europe since the introduction of Vol IXa. The intention of the course is to look at these modules and their requirements, examine how they overlap and fit together and what Companies need to do in terms of their legal requirements; training; changes and introduction of SOPs; and the links to other Departments - not just Pharmacovigilance.
WHO SHOULD ATTEND
This course will be of particular benefit to anyone working in Pharmacovigilance, including EU QPs / Deputies of Pharmacovigilance, as well as Quality Assurance; Compliance & Auditing and Regulatory personnel. It will also be of interest to anyone requiring an overview of this important new legislation.
Key Topics Covered:
DAY ONE - 24 March 2014
09.30 - Introduction & Welcome
The Legislation Outline for 1235/2010 & 2010/84
- Impact on previous legislation
- Enforcement of new legislation
- Purpose of the new legislation and its focus
- National variations
10.15 -The Impact on ICSR Safety Reporting in Europe
- Changes to expedited reporting
- Compliance monitoring
- Regulatory Quality Assessments - what and why
- The EU Product Dictionary Database - XEVMPD
- Electronic versus paper reporting - immediate changes and proposed
11.15 - Coffee
11.40 - The Impact on ICSR Safety Reporting in Europe...continued
12.15 - (a) PSURs/PBRERs
- Changes for EU PSUR submissions
- Revision of PSUR timelines
- Changes in the format of the PSUR - ICH E2C (R2)
- EU PSURs v rest of world
- The PSUR and Risk Management Plans
13.00 - Lunch
14.00 - (b) DSURs
- ICH E2F - The DSUR
- Content of the DSUR
- The DSUR and the PSUR/PBRER
- The IBD
15.15 - Tea
15.35 - The PV Master File
- The DDPS - What happens now
- Transition from DDPS to PV Master File
- The PV Master File - Purpose and Maintenance
17.00 - End of Day One
DAY TWO - 25 March 2014
09.00 - The New Legislation and Quality Management (QM)
- QC, QA and QM
- The purpose of QM
- Requirements of QM and examples of QM activities
- The responsibilities of the licence holder and QM
10.30 - Products with Additional Monitoring & Safety Communication
- ADR reporting and labelling
- RMPs and Labelling
- Medical information and RMPs
- Internal and external communication of new product safety issues
11.15 - Coffee
11.35 - Signal Detection Activities
- The EMA and Signal Detection
- Requirements from the MAH and Signal Detection
- Signal Detection and the internet
- Signal Detection and RMPs
12.30 - Lunch
13.30 - Pharmacovigilance Audits
- Format of the audit
- Risk based approach to audits
- Audit findings and Corrective Actions (CAPA)
- Audits and the Pharmacovigilance Master File
14.30 - Tea
14.45 - Risk Based Inspections
- The Inspection format
- The Inspection risk assessment
- Inspection scope
- Inspection findings
- Regulatory actions
16.30 - Close of Meeting
Graeme Ladds, Director of PharSafer, has over 20 year's experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. The last ten years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for large multi-national and national companies, and helping with regulatory inspections.
For more information visit http://www.researchandmarkets.com/research/drlfwg/new_e
Media Contact: Laura Wood, +353-1-481-1716, [email protected]
SOURCE Research and Markets
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
Aug. 28, 2016 02:00 AM EDT Reads: 1,761
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Aug. 28, 2016 01:45 AM EDT Reads: 2,140
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions wi...
Aug. 28, 2016 01:30 AM EDT Reads: 2,069
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Aug. 28, 2016 01:00 AM EDT Reads: 2,960
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 28, 2016 12:15 AM EDT Reads: 1,819
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 27, 2016 11:00 PM EDT Reads: 3,993
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Aug. 27, 2016 08:45 PM EDT Reads: 2,342
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 27, 2016 08:45 PM EDT Reads: 1,774
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Aug. 27, 2016 06:15 PM EDT Reads: 737
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 27, 2016 06:00 PM EDT Reads: 3,093
Enterprises have forever faced challenges surrounding the sharing of their intellectual property. Emerging cloud adoption has made it more compelling for enterprises to digitize their content, making them available over a wide variety of devices across the Internet. In his session at 19th Cloud Expo, Santosh Ahuja, Director of Architecture at Impiger Technologies, will introduce various mechanisms provided by cloud service providers today to manage and share digital content in a secure manner....
Aug. 27, 2016 06:00 PM EDT Reads: 731
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 27, 2016 05:15 PM EDT Reads: 1,579
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 27, 2016 05:00 PM EDT Reads: 1,884
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Aug. 27, 2016 04:45 PM EDT Reads: 1,636
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Aug. 27, 2016 04:00 PM EDT Reads: 585