What is an RDA Europe Node and how to get involved. Webinar by RDA Europe 4.0 to introduce the network of RDA Europe nodes and the process to become a new node.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Timea Biro - Research Data Alliance and opportunities for fundingdri_ireland
Presented at DRI Members Forum, 6th March 2019 by Timea Biro, Project Manager at DRI. Overview of DRI activities under the remit of the Research Data Alliance Europe 4.0 project and current funding calls open to early career researchers, data experts and domain ambassadors.
RDA Presentation by Hilary Hanahoe at Open Science 2020 event, Pisa 8th April - Sharing data across technologies, disciplines and countries, what is it, how does it work, how and why you should get involved
Georg Rehm. META-NET and META-SHARE: An Overview. Human Language Technologies: The Baltic Perspective 2010, Riga, Latvia, October 2010. October 8, 2010. Invited keynote talk.
Explore our comprehensive data analysis project presentation on predicting product ad campaign performance. Learn how data-driven insights can optimize your marketing strategies and enhance campaign effectiveness. Perfect for professionals and students looking to understand the power of data analysis in advertising. for more details visit: https://bostoninstituteofanalytics.org/data-science-and-artificial-intelligence/
1. CC BY-SA 4.0
RDA Europe 4.0 – The European Plug-in to the global Research Data Alliance” - has received funding from the European Union’s Horizon 2020
research and innovation programme under grant agreement Grant Agreement number: 777388. The content of this document does not represent
the opinion of the European Commission, and the European Commission is not responsible for any use that might be made of such content.
RDA EU 4.0 Kick-off Meeting
6-7 March 2018What is an RDA Europe Node and how to
get involved
RDA Europe
23 May 2018
#RDA #RDAEurope @RDA_Europe
https://www.slideshare.net/ResearchDataAlliance/rda-europe-nodes
23/05/2018 www.rd-alliance.org - @resdatall
2. CC BY-SA 4.0
Outline
Introduction
Daniel Bangert (University of Göttingen)
RDA Europe Node - The Netherlands
Lisa de Leeuw (DANS)
RDA Europe Node - Italy
Emma Lazzeri (CNR-ISTI)
Growing the network
Sarah Jones (Digital Curation Centre)
www.rd-alliance.org - @resdatall23/05/2018
3. CC BY-SA 4.0
Vision
Researchers and innovators openly
share data across technologies,
disciplines, and countries to address
the grand challenges of society.
Mission
RDA builds the social and technical
bridges that enable open sharing of
data.
www.rd-alliance.org
@resdatall
5. CC BY-SA 4.0
www.rd-alliance.org - @resdatall
RDA Europe National Nodes
RDA EU 4.0 builds on existing networks to create a European network of nodes to enhance
Member State cooperation and support of RDA in many European countries & vice versa the
representation of EU countries in RDA Global
23/05/2018
6. CC BY-SA 4.0
What does a node do?
Support data-related activities at the national/regional level
Act as central contact point between national data
practitioners and RDA
Promote the RDA vision and results through events,
workshops and meetings
Develop concrete actions to facilitate the uptake/adoption
of RDA outputs
Interact with national research funding bodies and advocate
for data issues
Participate in RDA processes and governance to represent
national/regional interests
23/05/2018 www.rd-alliance.org - @resdatall
7. CC BY-SA 4.0
Get involved!
Join the Research Data Alliance
https://www.rd-alliance.org/get-involved/individual-
membership.html
Get in touch with the RDA Node in your country/region to
collaborate on data sharing and RDM challenges
https://www.rd-alliance.org/groups/national-groups
Apply to become a new RDA Europe node
https://www.europe.rd-alliance.org/
Look out for RDA Europe grants for Early Career
Researchers, Experts, Ambassadors and RDA Output-
Adoption
www.rd-alliance.org - @resdatall23/05/2018
8. CC BY-SA 4.0
RDA Europe 4.0 – The European Plug-in to the global Research Data Alliance” - has received funding from the European Union’s Horizon 2020
research and innovation programme under grant agreement Grant Agreement number: 777388. The content of this document does not represent
the opinion of the European Commission, and the European Commission is not responsible for any use that might be made of such content.
RDA EU 4.0 Kick-off Meeting
6-7 March 2018
RDA Europe Node - The Netherlands
Lisa de Leeuw (DANS)
www.rd-alliance.org - @resdatall23/05/2018
9. CC BY-SA 4.0
RDA node NL: introduction
RDA in The Netherlands
Node: DANS (Data Archiving and Networked Services)
Currently 293 RDA members in the Netherlands; involvement
as group co-chairs and other RDA activities
www.rd-alliance.org - @resdatall23/05/2018
10. CC BY-SA 4.0
RDA node NL: involved parties
Engaging with
government, national
funding bodies, research
organisations, and other
networks (RDNL,
OpenAIRE NOAD, GO-
FAIR-node)
www.rd-alliance.org - @resdatall23/05/2018
11. CC BY-SA 4.0
RDA node NL: priorities
Promoting RDA outputs and recommendations
Certification
PID
www.rd-alliance.org - @resdatall23/05/2018
12. CC BY-SA 4.0
RDA node NL: communication
Liaising with specific communities: Social Sciences
and Humanities
Disseminating RDA activities and outputs in Dutch
via journal publications and other communication
channels
www.rd-alliance.org - @resdatall23/05/2018
13. CC BY-SA 4.0
RDA Europe 4.0 – The European Plug-in to the global Research Data Alliance” - has received funding from the European Union’s Horizon 2020
research and innovation programme under grant agreement Grant Agreement number: 777388. The content of this document does not represent
the opinion of the European Commission, and the European Commission is not responsible for any use that might be made of such content.
RDA EU 4.0 Kick-off Meeting
6-7 March 2018
RDA Europe Node - Italy
Emma Lazzeri (CNR-ISTI)
www.rd-alliance.org - @resdatall23/05/2018
14. CC BY-SA 4.0
Creation, Organisation and Management of
the Italian RDA Node
CNR is the Italian Node Coordinator (responsible: Donatella Castelli and
Emma Lazzeri, ISTI)
The idea is to collaborate with institutions, single persons, infrastructures,
working group and other initiatives
A community will be created and supported to facilitate the participation in
RDA activities.
IOSSG (the Italian Open Science Support Group) already joined the Node
www.rd-alliance.org - @resdatall
Italian Open Science
Support Group
ICDI
Italian Computational
and Data Infrastructure
Already Joined
the Node
Preliminary
Contacts
23/05/2018
15. CC BY-SA 4.0
RDA Italian Members
are currently 302
www.rd-alliance.org - @resdatall
0
10
20
30
40
50
60
70
ISCRIZIONI
Creation, Organisation and Management of
the Italian RDA Node
Organisation Type
Membership (2013-2017)
23/05/2018
16. CC BY-SA 4.0
Creation, Organisation and Management of
the Italian RDA Node
Italian RDA members will be
invited to join the RDA Node
activities
the new members of the RDA
Node community will become
RDA members by subscribing
the RDA guiding principles
Organisations/Institutions
willing to join the RDA Node,
no subscription fees will be
required at this stage, but they
will be informed about the
benefits of becoming
organisational members or
affiliates of RDA
www.rd-alliance.org - @resdatall23/05/2018
17. CC BY-SA 4.0
Italian reality:
Strong need for coordination in the fields related to RDA
National issues:
Research Infrastructures Coordination
Data related Services and Users need to get in contact (what are the
tools provided? Do the potential user know about them?)
DMP training and support will be carried out by the national node
Data Repositories
National Priority Area: Data Management Plan
www.rd-alliance.org - @resdatall
Creation, Organisation and Management of
the Italian RDA Node
23/05/2018
18. CC BY-SA 4.0
www.rd-alliance.org - @resdatall
What can the RDA Node do for the Italian
Open Science Community?
Facilitate the relations within the Italian Open Science community as a
catalyser of the project, Infrastructures, and initiatives on the national
level.
Promote the interest of the Italian community in RDA
Facilitate the participation of the Italian actors in RDA through the RDA
Europe 4.0 Open Calls
Organise events, workshop, training courses, webinars, on themes that
address the community needs and interests.
Make OS services and users meet
Italian
RDA Node
23/05/2018
19. CC BY-SA 4.0
Funder Engagement
Contact with major public and private funders are
already established, and in the next months the Italian
RDA node will be presented to the major Italian
stakeholders.
Contacts already set up:
MIUR (Italian Ministry of University and Research),
Tuscan Region
CARIPLO and
Telethon Foundations.
Contacts to be sought in the next 12 months:
Piemonte Region,
other public regional funders, other small funders
6 face-to-face meetings organized in the life span of the
project with funders.
Monthly update/contact via conference call.
www.rd-alliance.org - @resdatall23/05/2018
20. CC BY-SA 4.0
Promotion of open calls for European
participation in RDA
Open Calls will be promoted in Italian language
Calls will be promoted during the events sponsored
by RDA and the RDA National Node
Channels to be used in the first 12 months:
CNR and RDA EU Italian page websites,
Mailing list (Italian mailing list related to Open Science),
Facebook, Twitter…
AISA (Italian Association for the promotion of Open
Science) network.
IOSSG, ICDI, OpenAIRE dissemination channels.
Target: 10-20% of Italian RDA members
www.rd-alliance.org - @resdatall23/05/2018
21. CC BY-SA 4.0
Organisation of events to disseminate &
promote RDA activities and outputs
Events will be organised also in collaboration with
other OS realities (eg. OpenAIRE, OPERAS, SoBigData,
etc...)
Tentative themes for the National Node Workshop or in
collaboration with other RDA Nodes:
Next generation data repositories
Open Science in the Marine Sector
Other topics will be agreed with other members of the
community in the next 12 months
Other topics will be decided during the project lifetime
to align the RDA event themes with the current
scenario.
Target: 3 main events in 27 months of project
duration.
www.rd-alliance.org - @resdatall23/05/2018
22. CC BY-SA 4.0
Dissemination of RDA activities and output
and encouraging participation in RDA
activities and adoption of outputs
Dissemination at national level will be performed in Italian
targeting Italian Science and Popular Science Journals.
Publication in the CODATA Journal special issues.
Publications in Data related Journals and Conferences;
collaboration will be sought to produce joint publications
with other RDA nodes about RDA vision, strategy and
roadmap (at least 2 in 27 months).
Tentative training session in the field of Data:
A course or summer school on Data Stewardship will be organised
in the framework of the Doctorate Course on Data Science,
organised by CNR in collaboration with University of Pisa, Scuola
Normale Superiore, Scuola Superiore Sant’Anna and IMT
Webinars and seminars will be organised to disseminate RDA
Europe Work
Target: at least 1 dissemination event and 2 publications per
year
www.rd-alliance.org - @resdatall23/05/2018
24. CC BY-SA 4.0
Three waves of cascading grants
www.rd-alliance.org - @resdatall
Targets
3 in 2018
7 in 2019
3 in 2020
Total €462,000 in three waves
Process
RDA Europe 4.0 cascading grants providing
financial support for new National Nodes
€168,000 to be allocated in first wave
First call open 23 May until 27 July 2018
New nodes to begin in October 2018
Call details at https://www.europe.rd-alliance.org/
23/05/2018
25. CC BY-SA 4.0
How to apply for a cascading grant?
www.rd-alliance.org - @resdatall
Review the call criteria
Assess where you are strong and where you have gaps
Form collaborations and partnerships
Draft a proposal
Get in touch if you have questions
Suggest early participation to help build strong proposal
Submit by deadline of 27 July 2018
Apply at https://www.europe.rd-alliance.org/
23/05/2018
26. CC BY-SA 4.0
Q2. Key personnel in your proposal
List up to eight individuals, providing a brief (2-3
sentence) biosketch
Note affiliation, role they will play in your node, and what
specific skills they bring to your consortium.
We recommend forming a diverse group that can engage
varied stakeholder communities in your region.
www.rd-alliance.org - @resdatall23/05/2018
27. CC BY-SA 4.0
Q3. Current RDA activities
Explain what involvement your consortium has in RDA
Membership
Attending plenaries
Contributing to groups
Formal positions e.g. co-chairing, TAB members
Adoption of outputs
National engagement events
…………
Take the opportunity to profile the breadth of engagement
across different activity areas and personnel
www.rd-alliance.org - @resdatall23/05/2018
28. CC BY-SA 4.0
Q4. Planned node activities
How will you support the vision of RDA?
Engage a broad range of stakeholder groups
Represent and respond to national interests & priorities
Grow RDA membership
Increase the adoption of outputs
…………
Provide a detailed workplan of activities, including a
timeline indicating significant events and milestones
Activities should be open and community-driven to
promote consensus-building. See RDA Principles
www.rd-alliance.org - @resdatall23/05/2018
29. CC BY-SA 4.0
Q5. Community endorsements & support
Detail who is supportive of your application
What commitments they have made to collaborate or
assist in your activities.
Any financial contributions, formal endorsements and
other cooperation agreements.
A broad stakeholder mix with some backing from
funders and/or government representatives is
preferable.
www.rd-alliance.org - @resdatall23/05/2018
30. CC BY-SA 4.0
Q6. Sustainability plans
Consider how you will continue node activities beyond
the support provided by RDA Europe 4.0.
What financial or in-kind contributions can be secured?
What business models and funding opportunities will
be explored?
Being able to self-sustain activities and contribute into
RDA is critical so this section warrants close attention.
www.rd-alliance.org - @resdatall23/05/2018
31. CC BY-SA 4.0
Evaluation criteria
Existing RDA involvement (20%)
Actively involved in RDA activities > Point to contributions in the past 12 to 18 months >
have a good understanding of the RDA mission and principles > demonstrate work done to
support RDA and promote adoption of outputs.
Potential impact (30%)
Well-connected and influential > diverse range of stakeholders > strong relations with
national ministries and funding bodies > strategic investments in infrastructure > node
sustainability > integrate RDA with relevant EU initiatives > influence EU open science
strategy > detailed, realistic workplan > ECRs / experts / ambassadors
Community connections (20%)
Wide range of existing multi-disciplinary community connections > ability to recruit a large,
new cohort of RDA members > experience of community engagement and communication >
diversity and inclusivity > Activities should promote openness and balance > respond to
community needs
Sustainability (30%)
Have secured or have the capacity to secure self-funding or additional funding > detailed
plans for continuing work beyond the funded period > engagement with funders >
exploratory work on business models
www.rd-alliance.org - @resdatall23/05/2018
32. CC BY-SA 4.0
RDA Europe 4.0 – The European Plug-in to the global Research Data Alliance” - has received funding from the European Union’s Horizon 2020
research and innovation programme under grant agreement Grant Agreement number: 777388. The content of this document does not represent
the opinion of the European Commission, and the European Commission is not responsible for any use that might be made of such content.
RDA EU 4.0 Kick-off Meeting
6-7 March 2018
Thank you!
#RDA #RDAEurope @RDA_Europe
https://www.europe.rd-alliance.org/
nodes@europe.rd-alliance.org
https://www.slideshare.net/ResearchDataAlliance/rda-europe-nodes
23/05/2018 www.rd-alliance.org - @resdatall