Presentation of CRAASH Barcelona, the new project of Biocat (Moebio Barcelona). The initiative is a 12-week program that helps European research teams launch successful device, diagnostic and e-/digital health innovations to improve health and patient care.
The MaRS EXCITE (Excellence in Clinical Innovation and Technology Evaluation) program helps innovators collaborate with the health system to accelerate the pace of adoption of innovative health technologies in Ontario and global markets.
At the end of the program, innovators will have feedback and data on the effectiveness, competitiveness, and economic value of their medical devices or health technology. With this data, innovators are better equipped to approach payers in multiple markets for reimbursement.
Prioritized by senior executives from the health system, only technologies that have true breakthrough potential are allowed into the program.
For more information visit www.marsdd.com.
Panel discussion: Being a successful healthcare entrepreneur: lessons from Boston to Barcelona, with numerous experts from CIMIT, Boston, in economics, development and strategic planning of medical devices; in prototypes and patents and founders of several startups.
Presentation of CRAASH Barcelona, the new project of Biocat (Moebio Barcelona). The initiative is a 12-week program that helps European research teams launch successful device, diagnostic and e-/digital health innovations to improve health and patient care.
The MaRS EXCITE (Excellence in Clinical Innovation and Technology Evaluation) program helps innovators collaborate with the health system to accelerate the pace of adoption of innovative health technologies in Ontario and global markets.
At the end of the program, innovators will have feedback and data on the effectiveness, competitiveness, and economic value of their medical devices or health technology. With this data, innovators are better equipped to approach payers in multiple markets for reimbursement.
Prioritized by senior executives from the health system, only technologies that have true breakthrough potential are allowed into the program.
For more information visit www.marsdd.com.
Panel discussion: Being a successful healthcare entrepreneur: lessons from Boston to Barcelona, with numerous experts from CIMIT, Boston, in economics, development and strategic planning of medical devices; in prototypes and patents and founders of several startups.
Presentación hecha por el académico de la Universidad de Sydney y Queensland y miembro de la Academia de ciencias, tecnología e ingeniería de Australia, Michael Sargent, en el marco del seminario "Innovar para Crecer: El gran desafío de la década que se inicia" organizado por el Consejo Nacional de Innovaión.
Australian Business Forum helps Australian SMEs and businesses to understand the Chinese market and refine their China strategy.
http://abf.events/
ABOUT THE PRESENTATION
Presentation by Lorraine Chiroiu, Chief Industry Affairs Officer
and Head of AusBiotech’s China Programs - AusBiotech Engaging with China
Presentation on:
- Facilitating medical devices trade with China by breaking down the major barriers to entry
- Providing information about intellectual property (IP) management in China and outline the types of business structures that are possible for Australian companies entering China
Presented at the Fortune Forum 2015 Australian Summit
The Role of Health Research Wales in supporting Industry Research in Betsi Cadwaladr University Health Board (BCUHB)
International Clinical Trials Day 20th May 2014
Presented by Rebecca Burns, Health Research Wales, Industry Manager
2B Kalfhaus Opportunities and Challenges of Telemedicine EHiN 2014IKT-Norge
Lars Kalfhaus
Country Manager Roche Diabetes Care (ES)
Connect, Engage and Take Decisions
Opportunities and Challenges of Telemedicine Implementation
EHiN 2014, IKT-Norge og HOD
Karen Livingstone - ECO 17: Transforming care through digital healthInnovation Agency
Presentation by Karen Livingstone, Director of Innovation Exchange and SBRI Healthcare, NHS England: Transforming Health and Social Care Services - The Innovation Exchange and SBRI Healthcare at ECO 17: Transforming care through digital health on Tuesday 4 December at Lancaster University, Lancaster
Nhs innovation accelerator understanding how and why the nhs adopts innovationHugh Risebrow
Thanks Nael Clarke for highlighting Wessex AHSN report on adoption of innovation in the NHS. Innovation is difficult in any organisation, but why is it so much harder in the NHS than in say Apple, Amazon or most private businesses: My views:
1. Organisational success. In private b2c companies, success results from attracting and retaining customers through delivering innovative services which meet their needs better than competition. In the NHS, success is much more about achieving arbitrary political targets, and patients have limited choice.
2. Organisational incentives. Many innovative companies set divisional objectives around the proportion of income from new products.
3. Individual and team incentives. In successful b2c businesses, financial and career recognition/ promotion rewards are often linked to innovation. There is recognition that innovation may need a few reiterations to succeed. In the NHS, few get fired for preserving the status quo, but many lose out of they innovate and it fails first time round, and there are no individual or team incentives.
Many in the NHS seek to innovate in order to deliver better care at a lower cost. They are often faced with organisational resistance or at least inertia, and excessive bureaucracy.
Lesson 101 in management s that you get the behaviours that you incentivise. (How) should the NHS change the incentives? Is there scope for more NHS owned 'spin-outs' which allow private sector type financial incentives for staff, and greater freedom from NHS bureaucracy and governance?
Translate: Medical Technologies in the Leeds City Region is a new partnership of universities in the Leeds City Region with world-class expertise in the development of new medical technologies. Translate are working in partnership with DHEZ and the University of Bradford.
The UK Research Councils will deliver through the GCRF £1.5b in research grants for international development research over the next five years. This funding is new and additional to existing sources of research support like DFID, the Newton Fund, etc., which will continue. The GCRF represents the largest single boost to research council funding in their history and will create an entirely new stream of development research funding across arts, humanities, social and natural sciences, with particular opportunities for interdisciplinary research.
Presentación hecha por el académico de la Universidad de Sydney y Queensland y miembro de la Academia de ciencias, tecnología e ingeniería de Australia, Michael Sargent, en el marco del seminario "Innovar para Crecer: El gran desafío de la década que se inicia" organizado por el Consejo Nacional de Innovaión.
Australian Business Forum helps Australian SMEs and businesses to understand the Chinese market and refine their China strategy.
http://abf.events/
ABOUT THE PRESENTATION
Presentation by Lorraine Chiroiu, Chief Industry Affairs Officer
and Head of AusBiotech’s China Programs - AusBiotech Engaging with China
Presentation on:
- Facilitating medical devices trade with China by breaking down the major barriers to entry
- Providing information about intellectual property (IP) management in China and outline the types of business structures that are possible for Australian companies entering China
Presented at the Fortune Forum 2015 Australian Summit
The Role of Health Research Wales in supporting Industry Research in Betsi Cadwaladr University Health Board (BCUHB)
International Clinical Trials Day 20th May 2014
Presented by Rebecca Burns, Health Research Wales, Industry Manager
2B Kalfhaus Opportunities and Challenges of Telemedicine EHiN 2014IKT-Norge
Lars Kalfhaus
Country Manager Roche Diabetes Care (ES)
Connect, Engage and Take Decisions
Opportunities and Challenges of Telemedicine Implementation
EHiN 2014, IKT-Norge og HOD
Karen Livingstone - ECO 17: Transforming care through digital healthInnovation Agency
Presentation by Karen Livingstone, Director of Innovation Exchange and SBRI Healthcare, NHS England: Transforming Health and Social Care Services - The Innovation Exchange and SBRI Healthcare at ECO 17: Transforming care through digital health on Tuesday 4 December at Lancaster University, Lancaster
Nhs innovation accelerator understanding how and why the nhs adopts innovationHugh Risebrow
Thanks Nael Clarke for highlighting Wessex AHSN report on adoption of innovation in the NHS. Innovation is difficult in any organisation, but why is it so much harder in the NHS than in say Apple, Amazon or most private businesses: My views:
1. Organisational success. In private b2c companies, success results from attracting and retaining customers through delivering innovative services which meet their needs better than competition. In the NHS, success is much more about achieving arbitrary political targets, and patients have limited choice.
2. Organisational incentives. Many innovative companies set divisional objectives around the proportion of income from new products.
3. Individual and team incentives. In successful b2c businesses, financial and career recognition/ promotion rewards are often linked to innovation. There is recognition that innovation may need a few reiterations to succeed. In the NHS, few get fired for preserving the status quo, but many lose out of they innovate and it fails first time round, and there are no individual or team incentives.
Many in the NHS seek to innovate in order to deliver better care at a lower cost. They are often faced with organisational resistance or at least inertia, and excessive bureaucracy.
Lesson 101 in management s that you get the behaviours that you incentivise. (How) should the NHS change the incentives? Is there scope for more NHS owned 'spin-outs' which allow private sector type financial incentives for staff, and greater freedom from NHS bureaucracy and governance?
Translate: Medical Technologies in the Leeds City Region is a new partnership of universities in the Leeds City Region with world-class expertise in the development of new medical technologies. Translate are working in partnership with DHEZ and the University of Bradford.
The UK Research Councils will deliver through the GCRF £1.5b in research grants for international development research over the next five years. This funding is new and additional to existing sources of research support like DFID, the Newton Fund, etc., which will continue. The GCRF represents the largest single boost to research council funding in their history and will create an entirely new stream of development research funding across arts, humanities, social and natural sciences, with particular opportunities for interdisciplinary research.
How to Make Awesome SlideShares: Tips & TricksSlideShare
Turbocharge your online presence with SlideShare. We provide the best tips and tricks for succeeding on SlideShare. Get ideas for what to upload, tips for designing your deck and more.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
Consortium metrics discussion with IOM Drug ForumMark David Lim
Presentation made to the IOM Forum on Drug Discovery, Development, and Translation to explore the possibility of metrics that evaluate the performance of biomedical research consortia
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
This presentation was made at a large pharmaceutical company's R&D and corporate affairs campus - going a little more indepth than the one from the prior Science of Team Science Conference
EUPATI guidances for interaction between Patient organisations and other stak...EUPATI
David Haerry
Increasing patient involvment
EUPATI guidances for interaction between Patient organisations and other stakeholders in medicines development
Introducing the Proposal of a "Global Human Rights Performance Benchmark"CRT-Japan 経済人コー円卓会議
On July 15th, 2014, Caux Round Table Japan, EIRIS and the Business and Human Rights Resource Centre, jointly held a conference to introduce the proposal of EIRIS (Ethical Investment Research and Information Service) to integrate a global human rights performance benchmark.
View the full report of the event at http://www.crt-japan.jp/EN/press/140715_EIRIS_report_E.html
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
WHO Foresight Approaches in Public Health.pdfWendy Schultz
Suggestions for expanding futures research and foresight capabilities in an organization, with an emphasis on broad participation by stakeholders; includes examples of multiple futures methods and linked processes.
SNOMED by Professor Martin Severs FRCP FFPHM Chairman Management Board.
There is a media intensive (22MB) version of this presentation with an audio track and video at:
http://hinz.org.nz/media/SNOMED-ProfSevers/
Disclaimer: Huge + You may have to hit refresh a couple of times to get it to load correctly.
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Knowledge transfer, and evidence informed health policy-minster's meetingDr Ghaiath Hussein
A presentation given to the highest executive body in the Federal Ministry of Health in Sudan, which led to the adoption of a new evidence-based policy.
An article on contamination of Diethylene Glycol in Pharmaceuticals. Thanks to Dr. Ajaz S. Hussain for all teaching, sharing knowledge and supporting in professional development.
Specific ServPoints should be tailored for restaurants in all food service segments. Your ServPoints should be the centerpiece of brand delivery training (guest service) and align with your brand position and marketing initiatives, especially in high-labor-cost conditions.
408-784-7371
Foodservice Consulting + Design
Enriching engagement with ethical review processesstrikingabalance
New ethics review processes at the University of Bath. Presented at the 8th World Conference on Research Integrity by Filipa Vance, Head of Research Governance and Compliance at the University of Bath. June 2024, Athens
The case study discusses the potential of drone delivery and the challenges that need to be addressed before it becomes widespread.
Key takeaways:
Drone delivery is in its early stages: Amazon's trial in the UK demonstrates the potential for faster deliveries, but it's still limited by regulations and technology.
Regulations are a major hurdle: Safety concerns around drone collisions with airplanes and people have led to restrictions on flight height and location.
Other challenges exist: Who will use drone delivery the most? Is it cost-effective compared to traditional delivery trucks?
Discussion questions:
Managerial challenges: Integrating drones requires planning for new infrastructure, training staff, and navigating regulations. There are also marketing and recruitment considerations specific to this technology.
External forces vary by country: Regulations, consumer acceptance, and infrastructure all differ between countries.
Demographics matter: Younger generations might be more receptive to drone delivery, while older populations might have concerns.
Stakeholders for Amazon: Customers, regulators, aviation authorities, and competitors are all stakeholders. Regulators likely hold the greatest influence as they determine the feasibility of drone delivery.
Comparing Stability and Sustainability in Agile SystemsRob Healy
Copy of the presentation given at XP2024 based on a research paper.
In this paper we explain wat overwork is and the physical and mental health risks associated with it.
We then explore how overwork relates to system stability and inventory.
Finally there is a call to action for Team Leads / Scrum Masters / Managers to measure and monitor excess work for individual teams.
A presentation on mastering key management concepts across projects, products, programs, and portfolios. Whether you're an aspiring manager or looking to enhance your skills, this session will provide you with the knowledge and tools to succeed in various management roles. Learn about the distinct lifecycles, methodologies, and essential skillsets needed to thrive in today's dynamic business environment.
Org Design is a core skill to be mastered by management for any successful org change.
Org Topologies™ in its essence is a two-dimensional space with 16 distinctive boxes - atomic organizational archetypes. That space helps you to plot your current operating model by positioning individuals, departments, and teams on the map. This will give a profound understanding of the performance of your value-creating organizational ecosystem.
Senior Project and Engineering Leader Jim Smith.pdfJim Smith
I am a Project and Engineering Leader with extensive experience as a Business Operations Leader, Technical Project Manager, Engineering Manager and Operations Experience for Domestic and International companies such as Electrolux, Carrier, and Deutz. I have developed new products using Stage Gate development/MS Project/JIRA, for the pro-duction of Medical Equipment, Large Commercial Refrigeration Systems, Appliances, HVAC, and Diesel engines.
My experience includes:
Managed customized engineered refrigeration system projects with high voltage power panels from quote to ship, coordinating actions between electrical engineering, mechanical design and application engineering, purchasing, production, test, quality assurance and field installation. Managed projects $25k to $1M per project; 4-8 per month. (Hussmann refrigeration)
Successfully developed the $15-20M yearly corporate capital strategy for manufacturing, with the Executive Team and key stakeholders. Created project scope and specifications, business case, ROI, managed project plans with key personnel for nine consumer product manufacturing and distribution sites; to support the company’s strategic sales plan.
Over 15 years of experience managing and developing cost improvement projects with key Stakeholders, site Manufacturing Engineers, Mechanical Engineers, Maintenance, and facility support personnel to optimize pro-duction operations, safety, EHS, and new product development. (BioLab, Deutz, Caire)
Experience working as a Technical Manager developing new products with chemical engineers and packaging engineers to enhance and reduce the cost of retail products. I have led the activities of multiple engineering groups with diverse backgrounds.
Great experience managing the product development of products which utilize complex electrical controls, high voltage power panels, product testing, and commissioning.
Created project scope, business case, ROI for multiple capital projects to support electrotechnical assembly and CPG goods. Identified project cost, risk, success criteria, and performed equipment qualifications. (Carrier, Electrolux, Biolab, Price, Hussmann)
Created detailed projects plans using MS Project, Gant charts in excel, and updated new product development in Jira for stakeholders and project team members including critical path.
Great knowledge of ISO9001, NFPA, OSHA regulations.
User level knowledge of MRP/SAP, MS Project, Powerpoint, Visio, Mastercontrol, JIRA, Power BI and Tableau.
I appreciate your consideration, and look forward to discussing this role with you, and how I can lead your company’s growth and profitability. I can be contacted via LinkedIn via phone or E Mail.
Jim Smith
678-993-7195
jimsmith30024@gmail.com
Public Speaking Tips to Help You Be A Strong Leader.pdfPinta Partners
In the realm of effective leadership, a multitude of skills come into play, but one stands out as both crucial and challenging: public speaking.
Public speaking transcends mere eloquence; it serves as the medium through which leaders articulate their vision, inspire action, and foster engagement. For leaders, refining public speaking skills is essential, elevating their ability to influence, persuade, and lead with resolute conviction. Here are some key tips to consider: https://joellandau.com/the-public-speaking-tips-to-help-you-be-a-stronger-leader/
Employment PracticesRegulation and Multinational CorporationsRoopaTemkar
Employment PracticesRegulation and Multinational Corporations
Strategic decision making within MNCs constrained or determined by the implementation of laws and codes of practice and by pressure from political actors. Managers in MNCs have to make choices that are shaped by gvmt. intervention and the local economy.
Integrity in leadership builds trust by ensuring consistency between words an...Ram V Chary
Integrity in leadership builds trust by ensuring consistency between words and actions, making leaders reliable and credible. It also ensures ethical decision-making, which fosters a positive organizational culture and promotes long-term success. #RamVChary
5. Safe, efficacious & have correct
identity
Deliver the same performance as
claimed
Perform consistently over shelf
life
Made in a manner that ensure
quality
Will be available when needed
Patient and
Doctor
assume that
Drugs are
6. Lets think
What will happen if Pharmaceutical Industry is not
regulated in the world?
20. Unique Approach
International Conference on Harmonization
(ICH) was created in 1990
Agreement between the EU, Japan and the USA
to harmonize different regional requirements for
registration of pharmaceutical drug products
Unique because joint effort by regulators and
associated pharmaceutical industry trade
associations
21. ICH Philosophy
Identification and elimination of the need
to duplicate studies to meet different
regulatory requirements
More efficient use of resources in the
R&D process, as a consequence
Quicker access for patients to safe and
effective new medicines
22. Lets align and keep it clear …. that ICH
is neither a forum of global politics nor a
trade negotiation, but a scientific forum
mainly covers “new drugs”
guidelines provide “how to collect data
scientifically for marketing
authorization”
23. Step by Step Moving Approach
Regulatory Implementation
Adoption of GL by Regulators/Publishing ICH GL
Regulatory Consultation/Consolidation of Comments
SC Agrees to Releasing Draft GL
Consensus Building/Drafting of GL
24. Working Groups
Safety Efficacy Quality Multidisciplinary
Steering Committee
Endorses topics, guidelines, and monitors progress
25. The way leading Agencies work
1
• Amending
Existing GLs
2
• Issuing New
GLs
3
• Law
Amendment
Formal Vehicles
Q&A Seminars Publications Etc.
26. Implementation Process Flow
Topic Selection
Dissemination
Publication
Training
Implementation
Management
Good guideline topic
selection
Formal communication
process
Active distribution
Educating users
Putting guideline „theory‟
into „practice‟
Active monitoring
of utilization
Guideline must be value-
added and ‘implementable’
Use multiple avenues
Targeted; via meetings;
also to non-ICH groups
‘Early, often, all’; within and
across organizations
Integrated process; address
questions/issues
Feedback to ICH SC
Implementation StepProcess Actions
27.
28. A „mature‟ harmonization initiative
A series of technical guidelines emerging, a
dictionary of medical terms, electronic
standards and a common format
Multiple ICH conferences
Witnessing increased interest in and use of
ICH guidelines globally
Formation and evolution of Global
Cooperation Group (GCG)
ICH
Today
30. Following over a
decade of significant
achievements in the
harmonization of Q,
S, E requirements for
the registration of
new drugs in the
three ICH regions,
Is the work of
ICH mostly done?
Will ICH become a
maintenance-only
organization?
31. Proper balance b/w maintenance and new activities
New topics of high value & objectives are achievable
Most efficient use and management of resources
Flexible enough to deal evolving science/technologies
….. More transparent
Appropriate time to evaluate the future of ICH to ensure:
NO
34. Opening new Horizons continued
• Review
Current
Practice at
regional
and ICH
level
• Options
Strengthen
transparency
and
communication
• GCG
Communicat
ion &
engagement
with non-
ICH regions
& parties
35. Global Cooperation Group
Established March 1999 as sub-
committee of ICH Steering Committee
Formed to respond to this growing
interest in ICH guidelines
Name reflective of desire to establish
links with non-ICH regions
InformationSharing
JointMeetings
37. Yesterday Dream is a Reality Today
Moving beyond
bounds of ICH
Serve as unique forum
for harmonization
initiatives to discuss
Best
practices
Lessons
learned
Innovative approaches
to harmonization and
regulation
38. Road where traffic is moving ahead
ICH technical
guidelines
Harmonization/
regulation
Training and
capacity
building
39. There is no harm to have a Dream
One
world
One
patient
One drug
One
quality
One time
45. Membership of
Pharmaceutical Inspection Co-operation Scheme
(PIC/S)
A gate way towards best protection and promotion of
public health and Pharmaceutical industries