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Transcript: Corrections Is the Mechanism Acceptable Clinical Hold Decision Getting A Drug To Market And Post-Marketing Surveillance Applicant/Drug Sponsor FDA Accept Drug to Market Clinical Trials Completed Formulation Yes Complete Reviews Statistical Degragation Profile Assessed Are the results Significant? Extrapolation of Results Does it Contain enough Information in all areas Applicant/Drug Sponsor GLP Followed Audit those Approved by CDER Are all the Predictable Side Affects Present? Must Comply with FDA Clinical Trials in Humans NDA ADME Profile Depends on compound and MoA Pharmacological/ Toxicological Target and MoA known Any Questions? Did it affect the body in the way it was planed Are the Metabolites Toxic? Changes Made Review by CDER Once a drug/device has passed through Phases I-III, and deemed safe and efficacious, it gets marketing authorisation/license and is placed on the market. Involves monitoring the safety of a drug or device AFTER it has been placed on the market. Forms part of pharmacovigilance which is detection, assessment, monitoring and prevention of adverse events and reactions from pharmaceutical products PV not only assesses ADR but events such as overdose, misuse and exposure in certain groups like pregnancy and breast feeding All side effects of drugs cannot be anticipated based on pre-approval studies (involving hundreds to thousands of volunteers) Both FDA (USA) and MHRA (UK) have a system of post marketing surveillance and risk assessment to identify any adverse drug reactions that did not happen during the pre-approval phase They used this information to update patient information, and often reevaluate the licensing approval or marketing decision. Indications and Uses Identified No Medicinal Dose/Route/Formulation Safety Acceptable to Continue? IND Reviews Complete and Acceptable? Sponsor Notified of Deficiencies X Statistical Review Are the Metabolites Acceptable What is the FDA What the FDA Does Where the FDA Intervene Progress No Application Phase No X Application Fileable? Refuse to File Letter sent to Applicant Any DDI's Identified Advisory Comitte Meeting Yes X By Matthew Beck and Vishal Shah New Drug Application Received By FDA Review Phase Has GLP Been Followed All Paperwork Submitted Overdose Data No Deficiencies Continue To Phase I-III Clinical Trials Shelf Life Does it do what it says Approvable Letter Granted Changes Made Has the Plan been followed Referance List: 6 Differant Offices Bioavailability Biopharmicutical Review Paperwork Completed Specialist Review USA (FDA) FAERS (FDA Adverse Event Reporting System) Database of reported ADRS Useful tool for new safety concerns and manufacturers compliance to reporting regulations Reported by healthcare professionals and consumers MedWatch Program for healthcare professionals and public Report serious/adverse effects for drugs and devices Ensure safety information is communicated rapidly to ensure patient safety is not compromised UK (MHRA, Commission of Human Medicines) Yellow Card reporting system Monitor safety of all healthcare products in the UK (including vaccines, herbal medicines, devices and e-cigarettes) Found on the website or at the back of BNF By healthcare professionals and public Black triangle drugs (newly licensed drugs which require additional monitoring, any suspected reaction must be reported) Data Analysed Medicinal Yes All paperwork Completed Chemistry No Acceptance Phase Another meeting of all 6 offices Storage Requirements Identified Submission of New Data 1. Drug development and review definitions (2015) Available at: (Accessed: 22 July 2016). 2. Fast track (FDA) (2016) in Wikipedia. Available at: (Accessed: 22 July 2016). 3. FDA’s regulatory responsibilities (2015) Available at: (Accessed: 22 July 2016). 4. Information for sponsor-investigators submitting investigational new drug applications (INDs) (2015) Available at: (Accessed: 22 July 2016). 5. Kashyap, N.U., Gupta, V. and Raghunandan, H.V. (2013) Comparison of drug approval process in United States & Europe. Available at: (Accessed: 19 July 2016). 6. Legislation (2015) Available at: (Accessed: 22 July 2016). 7. The importance of pharmacovigilance, WHO 2002 8. Safety monitoring of medicines,, retrieved 21/7/2016 9. "Post marketing surveillance programs",, retrieved 21/7/2016 10. "About yellow card",, retrieved 21/7/2016 No Completed!!! Sponsor

Applicant presentation

Transcript: By Jason McFarland Presentation for IT help desk Ogden City Questionnaire Questionnaire Describe yourself professionally in a few words. Describe yourself professionally in a few words. I belive that others would describe me as hard worki... I belive that others would describe me as hard working and constantly striving to learn more. If your previous manager was in the room with us, what would he/she say about you? If your previous manager was in the room with us, what wou... She would say that I'm pretty fun to be around and ... She would say that I'm pretty fun to be around and an easy going person, but when it comes to completing a project, I make that my only focus until the project is done. What are the disadvantages of using imaging software? What are the disadvantages of using imagi... One disadvantage of imaging in an enterpri... One disadvantage of imaging in an enterprise setting is having to boot from the network. Since this is a network, if the servers are down or if there is a hiccup during the imaging process, you have to finish this manually or start again from the beginning. New hardware also requires its drivers to be on the deployment server before imaging. In our industry, what are some important trends that you see? In our industry, what are some important trends that y... One of the biggest trends in the IT industry is t... One of the biggest trends in the IT industry is the push for better and smarter security systems. Right now the IT industry has an ever increasing demand for people who can solve for existing security vulnerabilities. They say that Cyber Security is only as effective as the end user. Companies are pushing for ways to make it so even if the user is not the most tech savy, they have a robust security system to counter act user error. In your opinion a co-worker at the help desk is slacking, wasting time, and not shouldering his/her share of the load. How will you handle the situation? What if the person is continually chatting to you while you are working? In your opinion a co-worker at the help desk is slacki... In this first instance I would notify my team lead, as this ... In this first instance I would notify my team lead, as this is something that could escalate very quickly if I try to handle this on my own, as I do not have the authority to force my co-worker to work. I have experienced this issue in both previous and current places of work and school. I have found that the best option is to politely tell the person that I am trying to focus on my work, and do not need any distractions. If they continue to distract me, I have found that focusing on my work and not acknowledging them can be the best course of action. What, in your opinion, is the most difficult or challenging aspect of working in IT? What, in your opinion, is the most difficult or challengi... The rapid pace at which things change in the tech field c... The rapid pace at which things change in the tech field can be hard to keep up with, as there is always a better way to code something or a new piece of tech that needs to be fixed differently. What is your favourite aspect of desktop support? Your least favourite aspect of desktop support? What is your favourite aspect of desktop support? Yo... I am passionate about computers. Fixing an iss... I am passionate about computers. Fixing an issue with a system, whether it be hardware or software, is like a beating a game or solving a puzzle. One thing I dislike about desktop support is you can overlook a simple solution because you think the problem is more complex than it really is. A customer reports a problem that you have no idea how to fix. How do you respond and what do you do? A customer reports a problem that you have ... First I will let the customer know that I don't know t... First I will let the customer know that I don't know the solution and I will get back with them. Secondly, I will start with what I do know, such as familar error codes or weird behaviors that I have seen before. From there, I will either consult with my team to see if they know what is going on, or look up the solution on online tech forums. How capable do you think you are at handling stress? Give an example of how you have handled a stressful situation. How capable do you think you are at handling stre... I feel that I handle stress fairly well, as I try to approa... I feel that I handle stress fairly well, as I try to approach stressful situations in a unique way. I try to let stress drive me towards finding a solution in a quick and effieient way, while learning how to approach things from a different view point. When I worked as a paralegal, I was stressed about saying the wrong thing. To deal with the stress, I made sure I had all of my answers and phrasing correct before I gave it to the customer. Describe a situation where you have had to deal with a difficult person and how you handled it? Do you think you should have done anything differently? Describe a A In


Transcript: Medical Executive Committee (MEC) Credentialing Committee Chair Governing Board Oversees credentialing program, ensures hospital is carrying out activities in most effective/efficient manner. Ensure credentialing program is in compliance with all hospital's policies and other outside regulators Credentialing Committee (in departmentalized hospital) Typically 1st to see and review completed credentials file. Makes recommendation to Credentials Committee OR Medical Executive Committee (MEC) Medical Staff Services Professional Roles and Responsibilities of Key Individuals in the Credentialing Process Minnesota Hospital and Healthcare Partnership Ensure hospital receives all info needed in timely manner; up front, honest, willing to come in for personal interview if requested Board of Directors assumes all legal responsibility for the hospital, responsible for approving all bylaws, policies, procedures. 2 key functions for credentialing: 1. Attend to process (delineate steps, criteria to make decisions, fair and consistent) 2. Decision making (appointment, reappointment, privilege delineation) Reviews each complete application, makes recommendation to MEC regarding appointment, reappointment and clinical privileges. Members may also be asked to solicit info from past practice settings during this process. Department Chair Responsible for processing and maintaining applicant's credentialing file Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that MEC make recommendations to the Board of Directors regarding appointment, clinical privileges, reappointment, and corrective action. Develop policies for the MEC's role in fair hearing, investigation, appointment and privileges delineation process Applicant Assists in ensuring that the application and its supporting documentation reach appropriate individuals/groups at the appropriate steps of the process. Forwards the application to the MEC for submission to the board Ultimately informs each candidate by letter if application was approved or declined CEO

MathWorks Applicant Presentation

Transcript: MathWorks Applicant Presentation Grant Heffernan Date 1 Education 1994-1998 Bachelor of Arts: Economics Brandeis University: Waltham, MA Education & Interests Hobbies Running! Work Experience Work Experience SysAdmin/Infrastructure Engineer since 2000! Oncall since 2000 :( The Santa Cruz Operation 1998-2000 SCO Pre-sales engineer supporting government contracts, including NASA and RedStone Aresenal. America Online 2001-2011 America Online Finished my tenure here as a Principal SysAdmin. At various points responsible for some oldies but goodies, like AOLSearch and Brewster 2011-2013 Brewster Time for a startup! Responsible for all the (infrastructure) things. Mapzen 2013-2017 Mapzen Another startup! Goal: build an open source suite of modern mapping tools, including a geocoder, vector tiles and routing engine. SmartThings 2017-present SmartThings Responsible for the support of the A/V Platform which allows streaming and recording of real time video from client hardware, such as cameras and robot vacuum cleaners, to client devices (i.e. their phones). Also built a serverless environment to support an unrelated project... more on that to come! Project Study Project Study Ark: serverless infrastructure in the AWS public cloud. My role: take lambda code and API Gateway configuration hand rolled by development, and make it operationally viable. Project Overview Project Overview - simple REST API: take a device error code as input, provide troubleshooting details as output. - tried and true method: EC2. - serverless: API Gateway, Lambda (python runtime), DynamoDB. Why Serverless? Why Serverless? Upsides, downsides, and how the downsides are mitigated. Architecture/Request Flow Code & Workflow Code & Workflow How do we build and deploy all this? - Configure your SAM template. - Trigger a deployment. AWS SAM AWS SAM What is it and what can we do with it? Basic Resource Definitions Basic Resource Definitions Parameters, Conditions & Functions Custom Parameters, Conditions & Environments SAM templates are flexible. For example, specifying an environment at runtime allows for the creation of multiple environments with no code duplication. How? - specify parameters and conditions to take actions on - specify values specific to your environment - references those values using Functions Conditions & Parameters Parameters: enable you to input custom values to your template each time you create or update a stack. Conditions: define the circumstances under which entities are created or configured. Conditions & Parameters Environments Environments Create mappings defining parameters that need to be overridden per environment. Functions Functions enable you to assign values to properties that are only available at runtime. Functions !Ref ArkAuthorizerScalableTarget: returns the value of the specified resource. !Sub "ark-${EnvType}": substitutes variables in an input string. !GetAtt ErrorLookup.Version.Version: returns the specified attribute of the resource. !FindInMap [EnvParams, !Ref EnvType, CustomDomainName]: returns the value of a key in a two-level map. S3 Events S3 Events Scalable Targets Advanced Usage: DynamoDB Scalable Targets Pre/Post Traffic Hooks Pre/Post Traffic Hooks AWS SAM supports straight forward integration of CodeDeploy, and a variety of functionality therein, such as deployment methods: - Canary - Linear - All at Once In addition, it is possible to build in tests to the deployment process in the form of pre/post hooks: Success? -> Proceed! Failure? -> Rollback! Pre Traffic Hook Example Example Deploying Deploy Lessons Learned Lessons Learned Early adopter penalty. -> resolution: submit bug reports and work with AWS to resolve. Permissions. Permissions Permissions Elevated privileges are required to execute SAM templates. Why? Per AWS, the following IAM managed policies would be required to deploy their Hello World application. AWSCloudFormationFullAccess IAMFullAccess AWSLambda_FullAccess AmazonAPIGatewayAdministrator AmazonS3FullAccess AmazonEC2ContainerRegistryFullAccess -> resolution: account sandboxing. Why MathWorks? Why MathWorks? - culture, stability, people - local - science!

Charter applicant presentation

Transcript: Application review and Staff Recommendation Questions ? Information for School Opening Final Review of Application The Review Committee completes the evaluation of the application using the FL DOE Charter Application Evaluation instrument. Notification of the staff recommendation for approval or denial will be provided to the applicant. The applicant will be informed of the date and time of the School Board Meeting at which the resolution regarding approval/denial will be voted upon. Application Due Date: October / November 2014 Statutory Timeline An information session will be held with new schools opening in August 2015. The meeting is usually scheduled every March. Schools are then provided with all requirements for a successful opening and are introduced to OCPS staff members who work directly with charter schools. Denial of Application Charter School Application Cycle On or before August 1, 2014 no later than 4:30pm. 20 bound copies 1 electronic copy (USB) logged in order of receipt School Board Work Session Presentation Board members listed in the application will be asked to present the concept of the application to the Orange County School Board. 10 minutes to present with a Question/Answer session to follow (must meet media requirements) Sessions take place in the RB ELC Board Room beginning at 4:00pm. Interview with School Choice and Applicant Review Committee A date and time will be mailed to you along with notification of receipt for your application. All board members listed in the application are expected to attend the interview. The interview lasts about 1 hour and will be held at the RB ELC. Once the application is approved, contract negotiations will begin. The sponsor has 30 days after approval to provide an initial proposed charter contract. The applicant and sponsor have 40 days thereafter negotiate and notice the contract for final approval. Once approved, the charter applicant MUST participate in FL DOE charter applicant training. This must be completed at least 30 days before the first day of classes. Conclusion of Presentation The Charter Applicant will attend 2 meetings: A Board Interview and School Board Work Session August/September 2014 Approval of application If there is a recommendation for denial of the application, you have the option to withdraw your application before the School Board vote. If the application is denied, you may appeal the decision.


Transcript: University of Georgia is a beautiful school filled with lively people. Their range in students are diverse and is a sight to see. applicant: Cedric Mangham we're rapidly losing money Uga uses zell miller foundation and hope scholarship.undergraduates receive some kind of need-based financial aid and the average need-based scholarship or grant award is $8,923. As many as 1 in 3 first-year students won't make it back for sophomore year. The reasons run the gamut from family problems and loneliness to academic struggles and a lack of money. The student demographic male to women at UGA your schools financial aid plan rate a $11,634 your sat score at least has to be a 1230 to be considered to be accepted University of Georgia's ranking in the 2017 edition of Best Colleges is National Universities 56. At the University of Georgia the people are such a joy to be around no matter what ethnicity you are. Students and teachers aren't far apart with The student-faculty ratio at University of Georgia standing at 18:1, and the school has 41.8 percent of its classes with fewer than 20 students. fast crab The average undergraduate acceptance rate in 2015 was 53 percent. With the early acceptance rate of 65.8 percent fastcrab your tuition is whopping $11,634 generous maybe? your giving much love to your students University of Georgia has 43% percent of full-time undergraduates receive some amount of money and they give them around $8,923. what's our plan? Federal Work-Study (FWS) is a Federal Campus-Based Program that provides part-time, mostly on-campus jobs for students. Student work schedules are usually flexible and planned around the student’s class schedule application fee is $60 exactly 0.1% American Indian/Alaskan Native 9.7% Asian 7.6% Black/African-American 5.5% Hispanic/Latino 3.8% Multi-race (not Hispanic/Latino) 0.1% Native Hawaiian/ Pacific Islander 72.4% White 0.8% Unknown 53%of applicants are accepted up to 21,945 roughly apply a semester 4-year graduation rate 63% University of Georgia The average University of Georgia graduate with debt faces a $18,589 bill. by the success rate that's not as bad as you think Women 15,683 (56.9% Men 11,864 (43.1%) add logo here

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