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this is loud can you guys hear me good okay um so you know SBA s BIA brought you here today um how many of you actually know what SBI is is in what we do well I know all of you in the back - okay so of those of you that raised your hands how many of you have actually contacted us with questions you know about drug development guidance anything like that okay so you guys are gonna leave here today knowing when you go back if you have any other questions that come up where you can go for information so it's not just this conference we have an external presence - um so my name is Ray Nuala I work with Brenda Stoddard not there our director in the Cedars small business and industry assistance or SBI a program we acquired this program back in 2009 it was very bare-bones and so we have built it up to what what it is today and we're a very small group within a very large FDA organization but we're growing and we do our job with you know providing industry with as much guidance and pulling in all the subject matter experts back here to to make them accessible to you so so let's start with just a brief organizational chart just so you know where we are we're within cedar within cedar you know there's the office of new drugs there's different offices compliance pharmaceutical quality we're within the Office of Communications so we do a lot of outreach and within the Office of Communications we have the division of online communications the division of health communications and then we are located within division of drug information or DVI and you probably heard that term before so we work with our we're part of DDI and we're just a small subgroup so you know at FDA we know more and more now that small businesses often need help and and you know we want to increase that transparency so within within the office of medical products and tobacco we have different organizations or different groups that actually focus specifically on helping industry and it's not necessarily just small business but that's what we say because that's how it starts out so for example devices they're across downstairs across the hall they have their own program biologics has their own program tobacco so all these different organizations these different groups have their own way to to help industry and to provide provide that technical assistance that you may not have if you don't have an application in and you need general guidance we're there to guide you and to help you and also to educate you as I'll talk about so our mission you know we in a nutshell we're here to help you we want to engage with industry not only so we started off just answering questions over phone and email which I'll talk about you know you can call us Monday through Friday anytime email us and we respond to you but now more and more in the past couple years we've been going out to educate so these conferences I'll talk about other things we do so it's not only answering the questions it's being proactive and decreasing or increasing the transparency and decreasing that wall that a lot of industry kind of perceives is between them and FDA we really want that information out there because it not only helps you but it helps FDA you know if you're submitting more complete applications and you have more knowledge it's less work on the FDA employees and you know we can get better applications and get those drugs out there so our audience like I said you know we started what we started off as cedar small business we kind of identified with the small business because we thought they're the ones that really need that guidance and as you can see here so so by definition small business is less a company with less than 500 employees including affiliates as you can see here we're really split it's about half and a half who our audience is so we have large pharma we have small businesses but that doesn't mean that the large companies don't need help so according to our surveys at our conferences about a quarter of our audience has submitted an application to the FDA a marketing application about one half has not about 5% is in the process and about 15% they don't really know I don't know what that means but but that just goes to show you know even though half our audience is large Pharma they still have never submitted application it may be a new person it may be somebody that's working on a new project that's not familiar so even if you've been in industry for a while or you know if you are with a large company there's always new questions and new things because you can learn and that's what we're here for um so you know you've seen this geo map before from Jeff and this is from one of our previous conferences and so thanks to technology we're now worldwide we're global so it started with email we could answer emails from people all over the world you know some of our hardest questions come at like 5:00 or 6:00 in the morning from India and China from those companies I mean it's it's 24/7 right we get these questions and we answer them but now with all this webcasting we can webcasts like today our webinar conferences are webinars things like that so we really truly are global and it's pretty amazing so instead of telling you about what we do I'm we put together this cute little 90 second video just to entertain you post lunch so you know you can take a look you can you can get an idea of what we do and then I'll go through the different items in detail the journey to develop and market a human drug can be long complex and filled with regulations but FDA seeder small business and industry assistance or SBI a is here to help SBI a provides education and answers to help all regulated pharmaceutical industries not just small business all over the world what do we offer web resources for all your questions and training needs the popular regulatory education for industry or Fredi conferences free events that offer direct interaction with FDA subject matter experts and provides RAC credits we offer free webinars to share FDA's knowledge and expertise featuring live question-and-answer sessions video and audio archives and virtual attendance from anywhere in the world we publish the seeder SBI a chronicles a brief enewsletter and podcasts that highlight a specific and timely regulatory topic and we offer in-depth seeder learn web based learning tutorials stay current by signing up for our listserv or connect via LinkedIn and best of all everything is free so I'm going to start by echoing okay okay well I'm gonna kind of are you familiar with our website SBI a it's fda.gov or slash cedar SBI a anyone here use it no okay that's actually really good because you're gonna get a great resource so we put together this website and I'm gonna show you where it is and basically you know the FDA FDA gov I'm sure you've frequented that and it's huge and it's really easy to get lost in and I would always end up using that search engine and it would bring me to old guidances and old information so we put together a website specifically for industry right here and again it's FDA deca /c duress BIA and we organized everything we used different types of like Google Analytics data questions that we received from industry and we use all this information to develop this this web page and there is a ton of information here okay so when you come to this website you know it's organized that the bulk of the information is in the center here and it's organized by topic so let's say you need to know some you want to know you have a question about IMD's so you go to drug development scroll down there's information about engaging with FDA IND submission so you know they're just good place markers so you know where to start you have a starting point you know where to get your information and we're constantly updating this with you know new links and deleting out the old links but it's really useful right addresses for regulatory submissions people often don't know where to go for that this is one of the meet that one of the meeting pages that Rachel was talking about the guidance is for requesting pre nd meetings type C meetings we have courses here on how to request meetings with FDA so there's really a ton of information and it's not just drug development if you're filing an NDA or a PLA you know there's there's a ton of information here too so just depending on what you're looking for and it's just very easy to find this instead of just going to the search engine and not knowing where you're going we also have resources at the bottom guidance guidance documents we have statistics a lot of people want to know IND approve how many have been submitted that type of thing we've got statistics on that economic incentives for people that need to know you know how do i how do i to get grants things like that so we have all that and then we also always try to keep our spotlight box updated with upcoming events and recent events so we have this webinar that I'll talk about that we just posted and I think it'll be of interest to all of you I'll talk about that one in a little bit we have our conferences here we have just information office of pharmaceutical quality annual report we work at different offices and we actually have a copy of this report out there so if that's of interest to you you know we post it we make it available we work with different groups and so this is general information um if you want archives of all our webcasts our newsletters all these learning opportunities you click on that right here cedar s BIA learn and this is organized in much the same way but the information is different so if you want to know what has FDA what type of training have we put out there or for industry as far as inds you would click on new drug development and safety scroll down and there's a ton of information here these are the slides and recordings from previous conferences we have webinar webcasts we have newsletters we have online learning courses like this one is the CMC perspective of the IND that's very useful so there's a ton of information here that you can really use and it's all organized by topic and it's all training pretty much not official training but but things that you can use to further your knowledge in this learning resources box we have webinars conferences these are different things that we put out and I'm going to talk about this in just a minute over here we have SBI a resources in Chinese which is fairly new and we're starting to translate webinars into Mandarin and so that's another you know item of interest especially since we're global now for those of you that are in China right now so we're hoping to do more and more and we work with different offices to do this within different groups within FDA so there's really a lot of training information here and I'm going to go through each one of these learning resources one on one but basically if you say you want slides from today's conference you can come to cedar SDI you learn you can click on conferences and workshops and then once they're posted you know you would find them there's there's gonna be a link saying presentations and slides but if you don't know what you want then you can always go to the topic and then the individual lectures will be posted there and the same goes with say our online tutorial courses you know everything's posted here or you can go to the individual topic and find it there our webinars and and I'll go over what what all of this is in a minute so let's get back to my slides okay okay so works and conferences while you're all here so you know what we offer as far as workshops but this is the general ready conference and typically we have been offering this in conjunction with CDRH this dual track conference for a couple years now actually I think we started in 2013-14 something like that 2012 okay um and so this is in conjunction with CDRH and we typically offer it in the spring and the fall in the spring usually we analyze our registration data to see where the companies are concentrated both devices and drugs and we go out to different areas and we travel with our little tour group here so we travel and we tried it last year was in Atlanta the year before I think it was in Minnesota so we try to cover different geographic areas where those companies are located but now we are only going to be offering it in the spring because it's webcast now so whoever was going to come to Maryland in the fall can always join on in the spring and we do have budgetary constraints as brenta mentioned earlier with the government and so like I said these are dual track conferences um but we also offer topic specific conferences throughout the year and I don't know if any of you has anybody been to any other conference other than this ready conference one person okay so we offer we're trying to offer three or four a year we just had the generic drugs forum in April and that was also webcast and that had record attendance it was it was very highly attended we are planning we just acquired the clinical investigator training program sit see has anybody been to that okay that will be a three-day conference in Maryland we have not announced it yet but if you want to mark it on your calendar is it will be November 13th to 15th in Maryland and we will be going over all aspects of clinical studies so it's you'll be learning a lot statistical structure or preclinical and clinical science rare diseases ethical requirements it's it's a very packed three days that is the one exception where you know we say everything we do is free that's the one exception registration will be about $400 which isn't bad for a three-day conference and it will not be webcast so you will have to attend in person if you're interested so mark your calendars for that November 13th to 15th we have not yet announced it formally though and like I said we're usually webcast and you can get black credits regulatory affairs certification credits we are hoping in the future next year's conference that we can provide continuing education credits for those of you that you know are physicians or pharmacists nurses and those credits we're hoping to get that too and then these are some just examples you know in the past couple years we've been we've had a focus of an eye on DS for our general ready conferences in the spring and fall and that's because you know every time we have a new audience and this is a topic that everybody needs you know people are constantly learning more and more and there's new turnover in the industry so that's what we've been kind of sticking to the same topics but you know we've done things we've done GCPs we've done we've done drug registry registration and drug listing so we always rotate but we found that this topic is really sticking and that's why we've done it for the past couple years and then some of our topic specific conferences we worked with opq to bring on the pharmaceutical quality symposium we've done some on generic drugs prescription drug labeling that was a big one GMP s again inspections and then the 6e course which is coming up so we're this year we're hoping to have a couple more maybe three more including Susie so we'll see where that goes but you know I'll let you know how you can find out and again all our recordings are available on Etsy duress BIA learn and also at SBI a events comm so you can always go back and reference or show your colleagues and urge them to join live next time we also present so for instance we always every year we go to the small events Business Innovation research SBIR and small business technology transfer conference which is usually in a different location every time but it's put on by NIH the National Institutes of Health and here there's small businesses in healthcare that are very very early hot you know of them are not at the point of filing an IND or their right at that point and they need a lot of preclinical guidance just you know they don't know what's coming up ahead what they have to prepare for it because they're really they're looking for grants so we go there and we talk to them one-on-one we present we talk to them and we let them know you know we guide them so whatever questions they have we answer and we provide them with contacts and re erences so it's it's really useful we go there every year we also Brenda was just in Puerto Rico last week presenting with the office of minority health so that's another one we've been going to we that were asked to present at all so every year we do the NIH commercialization accelerator program or NIH tap and that's when there's small companies that come and they're on an 18-month roadmap so they come to this and they present their ideas to a panel of different agencies and they get feedback so I think we've helped about 15 companies in the past year so you know we're always looking for new ways to reach out and kind of expand our offerings we're not really limited by that much so so if anybody ever has any ideas we're very receptive to feedback if you have ideas and how you would like to see us grow new offerings we're very receptive and we're always looking for that you know on your surveys or email us talk to us we we wouldn't be here we wouldn't be anything if it wasn't for our audience because we're here to help you webinar does anyone attended any of our webinars okay well these are very very useful so they're kind of like mini conferences if you take any one of our subject matter experts here and put them on a webinar screen it's really you know it's it's you get that information it's they're usually an hour long but now we have extended webinars that are anywhere from three to eight hours long and that's when we have multiple speakers so it's kind of like a half-day conference everything is webcast everything is online and and again it's global for that reason and everything you know is archived on our and again lack credits are also available some webinars that you may be interested in that when I showed you in the spotlight box on the seat on the fda.gov forward slash cedar SBA you learn we just released a pre-recorded webinar so some of our webinars are live with Q&A sessions just like you have here so you would type it into your chat box the questions and you get a response and some of them are pre-recorded so if there's a new new forms or new guidances and and we just want to put the information out there but don't want a live webinar so this one that was just released was on the new forms 1571 and 356 h and it really it's very in-depth it walks you through the forms the requirements what's changed the sno-med CT how to get that information how to search for your terms it also goes over combination products and how to fill out the forms for that how to do your request for designation all that and then what's great is there's a live walkthrough with mock date data so you're able to see how those forms should be filled out and what's new with them so I highly recommend that all of you take that again it's on our webpage in the spotlight box we also we have not announced this yet either so you guys are getting a lot of new information here in June we will be having another webinar June 19 from 10:00 to 2:00 Eastern Time on post marketing adverse drug experience paid and risk evaluation and mitigation strategies programs and we will also include points to consider for an inspection so that's another one June 19th 10:00 to 2:00 and we'll be announcing that pretty soon - that hasn't been announced formally yet and that I think is also posted at FBI events calm right now yeah we just haven't advertised and we're also hoping to do a webinar and this year later this year on grants and waivers so that's another one that's that's of interest is particularly those small businesses that may not have all that money so these are some examples of past webinars you know we work again we work with different offices and divisions throughout Cedar and even throughout FDA to put these on we go out and Brenda does a lot of this she goes out and gets those subject matter experts to present she finds out what topics are is industry really looking for and depending on their availability availability we bring that to you so these you know they're really invaluable everything's free everything's webcast that you can join from anywhere in the world and you get your credits other things we do we interact with foreign regulators so a lot of times foreign regulators from different company countries Rwanda different companies countries come to us and they I'm okay and you know they need guidance so we talked to them we explained our drug drug approval process we work with the intern at the Office of International Programs to go over this to consults and get questions answered and they have questions for us we have questions for them we also try to publish as much as we can I'm gonna speed through these because I'm short on time I personally I write the seeder SBA chronicles which is a newsletter I put out every other month it's not really a newsletter it's just a brief two-page summary of a particular item of interest to industry so these are some of the issues that we've done this past year Bidoof a-- the doofah homeopathic drug regulation we also have one that I'm working on right now on the fairs database the fairs public dashboard which is an adverse event reporting dashboard which is of a lot of interest to industries if you don't know about it look for that we have online tutorial courses and this is all on cedar SBI a learn and these are modules that you can take free of charge just to educate yourself there are multimedia tutorials and they're they're really useful so how do you stay connected how do you find out about all this well if you're not on our email update list on our website at the bottom we have get email updates you click on that sign up with your email and you'll get all our information right to you our new offerings courses webinars conferences in addition to new guidances Federal Register notices anything that's of interest to industry and we're on social media now so LinkedIn if you're not following us be sure to follow us there's there's a link at the bottom of our webpage to right down right down there follow us on LinkedIn or you can go right to our LinkedIn page and again it's similar to what we put out via email but it's social media so it's just always populating your feed we're trying to get into Twitter so I last generic drugs forum we actually had a Twitter chat and we're hoping to make this available at future conferences and then finally our grunt work we answer emails we answer phone calls contact us with your questions don't hesitate you know we always get back to you within 48 hours if we need to consult out we still let you know we need to consult out and this is the situation but we are your point of contact if you don't have an application and here's our contact information again please send us your questions send us your feedback we're here to help you