All posts by Christian Souza

DSCSA, HDA, PDG

2 Organizations You Need to Join to Get Ready for the DSCSA Phase II

If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join. 

The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements for the DSCSA for 2023. The PDG is a 501(c)(6) nonprofit business association requiring a yearly membership fee to join. 

The other is the Healthcare Distribution Alliance, or HDA, which is a long-running organization that represents many members of the pharma supply chain in a quest to advocate for public policy that supports patient access to medical products through safe, efficient, and effective distribution. The HDA also requires a yearly membership fee.

Today’s post will look at both organizations, profile what they do, and then let you know why joining them is crucial for getting the most out of the DSCSA.

Continue reading 2 Organizations You Need to Join to Get Ready for the DSCSA Phase II →
CBD, Hemp, Marijuana

Does the DSCSA Affect How the Medical Marijuana Industry Is Regulated?

The Drug Supply Chain Security Act was enacted in 2013 to put protocols into place for the serialization and traceability of pharmaceuticals that move through the drug supply chain – from manufacturer through to the distributors until they reach the hands of the patient. The goal being to ensure the safety and purity of each medication. 

With medical marijuana being legalized in more states, this brings up the important question of if and how medical use marijuana should be handled under the guidelines of the DSCSA. Currently, the only states where medical marijuana is prohibited for all uses are Nebraska, Idaho and South Dakota. For the rest of the country, there are circumstances in which marijuana can be legally dispensed and consumed with a doctor’s prescription. Obviously, there’s the need for strict regulations, but the process for putting these regulations into place remains a little cloudy. 

Continue reading Does the DSCSA Affect How the Medical Marijuana Industry Is Regulated? →
DSCSA, EPCIS

EPCIS GUIDE for your organization

*NOTE – We are including a Free Trading Partner Integration template for you to download at the end of this article.

The 2023 DSCSA requirement looms in the near future and pharma companies are frantically working together to create and implement the technological goals that create the interoperable system by November 27, 2023. To achieve the three areas of interoperability as defined by the PDSA—exchange, verification, and tracing—these companies must also land on a common informational framework. 

In other words, to create a system that allows for the DSCSA vision of “fully interoperable, electronic tracing of products at the package level,” the industry needs to pick a common standard and use it throughout pharma. I discuss the challenges in my previous article: Drug Supply Chain Security Act, Phase II: Here’s what you MUST know.

Gary Lerner, the president at Gateway Checker Corporation, explained what it would take to make this happen. In short: “Capturing and exchanging information at this level of specificity requires a common information framework.”

Continue reading EPCIS GUIDE for your organization →
COVID-19, DSCSA, FDA

Impact of COVID-19 on DSCSA Implementation

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Before the pandemic struck, the pharma industry was working feverishly to implement and enforce all the requirements of the DSCSA, especially the Phase II requirements scheduled for November of 2023. When COVID-19 dramatically changed the business landscape, the implementation became even more of an uphill battle, with both time and the pandemic acting as a cause of concern. 

In today’s post, we will look at COVID-19 and its impact on the DSCSA: from the FDA loosening some of the guidelines to the different areas of the DSCSA that are being impacted the most. If we can understand the relationship between these two, we can have a better grasp of realistic understandings and the best course of action moving forward.

Continue reading Impact of COVID-19 on DSCSA Implementation →
DSCSA, FDA, Saleable Returns Verification

Why the FDA Extended The Saleable Returns Verification from 2020 to 2023

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In 2020, most things did not go as planned. Considering the overwhelming impact of the worldwide pandemic, the pharmaceutical industry was far from immune to last year’s instability.

One of the major changes came with the Saleable Returns Verification’s extension. Despite being originally scheduled for a 2020 enactment, the FDA recently announced their plan to extend, yet again, the Saleable Returns Verification enforcement until 2023.

What does this really mean? Well the FDA won’t enforce it. So should you not care? It’s not that simple.

Legal liability

Remember, the law is the law. So the Saleable Returns Verifcation did become a requirement of the law this past November 27th 2020.

Continue reading Why the FDA Extended The Saleable Returns Verification from 2020 to 2023 →
DSCSA, EDDS, EPCIS

Drug Supply Chain Security Act, Phase II: Here’s what you MUST know

As 2020 transitioned to 2021, we took another step closer toward the implementation of 2023 Drug Supply Chain Security Act, Phase II. From manufacturers to wholesalers, pharmacies and other stakeholders, many uncertainties are swirling around the subject, so today we are writing to try to dispel some of the concern.

Let’s start with an overview of DSCSA Phase II and its components.  

DSCSA Phase II, which goes into effect on November 27, 2023, is intended to roll out the electronic tracing of products at the package level.  To make this happen, the 2023 requirements are comprised of three specific parts, and they are as follows:

Continue reading Drug Supply Chain Security Act, Phase II: Here’s what you MUST know →
UDI

European Medical Device and In Vitro Diagnostic Medical Device Regulations Conference

Author Karen Fleshman

Once again I’ve asked Karen Fleshman, co-founder and COO of Haskins Advisory Group, to step in and cover the recent EU MDR and IVDR Conference that focused on Unique Device Identification (UDI).  I’ll return after the holidays with more coverage of pharma serialization.  Thanks Karen! –Dirk.

On December 4 – 6, 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations Conference was held in Orlando, FL. The conference was designed to educate, support, and assist US based medical device manufacturers in gaining critical insight on the requirements of the European Union (EU)’s Unique Device Identification (UDI) compliance program. Continue reading European Medical Device and In Vitro Diagnostic Medical Device Regulations Conference →

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And as she grows, she will be simply as afraid of him as you may be. And be vulnerable to falling into abusve relationships herself. You know in your heart of hearts that you’re not unreasonable, that this isn’t OK behaviour of his, and that it is not good to stay with someoone you worry. He claimed to not have accomplished it, but I feel so ugly. The lewd assertion left Ms Delgado’s daughter and associates feeling “uncomfortable” and she thought “no doubt many other women too” could be made uneasy by the signal. Send me exclusive offers, unique present concepts, and personalised ideas for shopping and selling on Etsy.

  • Some feedback learn “this guy is built differently” and “lucky you’ve received that hat to maintain you warm”.
  • ’ I kid you not,” the Oscar winner revealed to The Sunday Times, per People.
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Looks like those stereotypes have just been thrown on their head, as Men’s Health turned the best-selling journal within the sector for the first half of 2009. FHM had been the best-selling title for the previous thirteen years, however it appears today’s males have gotten increasingly well being aware. Joe Blogs is commonly depicated as a beer-chugging, X-Box taking part in slob who loves curry, loves boobs and blondes. And vehicles and hilarious ‘pranks’ involving petrol and singed eyebrows. But he still faces sentencing for making indecent pictures of a kid. No a part of this website or its content material could additionally be reproduced with out the permission of the copyright holder.

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After widespread outrage over the publication of topless footage of the Duchess of Cambridge, the 42-year-old tabloid institution of Page three is once extra under threat. A few cold showers beneath a waterfall and tv historical past was made — the nation fell in love with Myleene, 33, all over again. With her 50s-style glamour woman curves and lightweight tan, curvaceous Kelly is the right mannequin for her beach style vary.

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A COUPLE who shared a passionate kiss on the dancefloor of their native have been ordered to stop as it’d offend other drinkers – just days after the pub hosted a go to by two topless glamour fashions. The ladies initially had a £5,000 goal but that has already been smashed after reaping in money by way of a funday, sponsored occasions and other fundraising evening. They now have nearly £13,000 raised and want https://xxxdasi.net/ to reach £15,000 by selling their calendars. The girls then went to Newcastle F.I.T. Club on High Bridge within the metropolis where they donned boxing gloves to symbolise preventing most cancers. A few years in the past I learn an article in one tabloid about how all cabriolets were now being bought by middle aged females.

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Please observe, as a end result of import regulations we are unable to ship framed artworks outside of the UK. A man has gone viral after working topless within the snow alongside roads in London on Sunday night time. Dr Hands believes the can marketing campaign was problematic in perpetuating sexist stereotypes, though she stresses that the models she spoke to shared along with her fond memories of a bygone period of promoting.

That would mean she was filmed by 5 separate productions over a fourteen-year period, and he or she appeared in the opening credit of seven Bond movies in total over an eighteen-year period. For the time being all new registrations have been suspended as a outcome of an inflow of spam. I am looking in to the problem and hope to have it mounted soon. “I’m actually excited for them to come back out now as a end result of I poured my coronary heart into each, and I’m desperate to see what individuals will assume. “An alternative comes alongside for a low-level robbery – a couple of hundred grand at a safety depot – and Tash persuades her husband, brother and their associates to do it.

He meant to open more clubs – including one in Cardiff – and added that it was in his interest to set excessive requirements. Referring to public order problems, he said they weren’t alcohol led and prices have been comparatively costly. Customers can pay £10 entrance fee to The Gentlemen Only club, and then pay a minimal of £10 if they need one of the topless dancers to perform at their table, councillors were informed yesterday.

  • Now nicely past “fat girl” roles (whatever that even means?), Kate Winslet continues to be walking the stroll.
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However, she then starred in The Baby on Sky Atlantic and HBO in the US, as a woman unexpectedly landed with a newborn that turns out to have violent, manipulative powers. A taster pilot for High End Homeless was originally commissioned by Channel four and shot in London firstly of the 12 months. The stand-up and star of Sky horror-comedy The Baby, is writing and set to star in the semi-autobiographical High End Homeless, with six 30-minute episodes ordered. Madge unveiled an exhibition of the guide at Art Basel Miami last week, a star-studded competition attended by the likes of Leonardo DiCaprio and the Kardashians.

It’s made by the manufacturing firm behind Bodyguard and Line Of Duty, and Kenny was supplied the chance to put in writing it after she scripted an episode for one more of their reveals, Save Me. “I started writing younger, I was 19, and honestly I don’t suppose I might do one with out the opposite now. Measure the width and peak of the wall you wish to wall mural and add 10 cm in each instructions. Nigerian music star, Davido and his partner, Chioma have…

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Iconic

The deputy editor of the month-to-month journal Mike Shallcross mentioned that the model new breed of male chooses ‘solid, actionable advice’ about health, vitamin, psychological health and fitness over ‘topless Hollyoaks girls’ or costly clothes. Her wardrobe included a nightie and school uniform. The Sun newspaper has had images of topless women on its Page 3 since November 1970. Nina Carter, one of the first Page three girls within the Seventies, mentioned these pictures send out the incorrect message.

We goal to ship out all unframed prints within 10 working days. If you have any questions or considerations, contact our team at Nina Carter is supporting a campaign calling for The Sun to remove photos of topless ladies.A former Page three lady is supporting a marketing campaign to ban topless fashions from tabloid newspapers. The committee heard that Hardman, who did not attend the photo shoots, persuaded 4 younger women who had been in contact with the young offending staff, to pose topless or nude for cash, with £120 supplied for a full naked shoot. A SENIOR Kirklees Council social employee who focused vulnerable teenage women by encouraging them to pose topless or nude for bogus modelling companies has been struck off.

The video sees the 2 exchanging words while they dared each other to cross the battle line separating them. Sooner than later did the struggle start with heavy punches flying everywhere. Sorry, we aren’t accepting comments on this article.

Jaw-dropping UFC star Brittney Palmer has been named UFC Ringcard Girl of the Year for the fourth time. Throughout the film follows the video sequence exhibiting the most heinous types of abuse of a lady. Filming occurred over three days in South London, and a supply close to the group admitted response to the advert was overwhelming. Photo postcards are a good way to remain in touch with household and associates.

She decided to treat her 1.1 million followers by posting a topless photo after learning about her newest accolade. These adverts enable local companies to get in front of their target audience – the native people. A mum was left shocked that an indication offering free rides to ‘topless girls’ was on display at St Giles’ Fair. So excess of forty,000 people have signed her petition instantly asking Dominic Mohan, The Sun newspaper editor, to remove footage of topless women from his paper. But just as digital technology is being used to broaden Page 3 so additionally it is empowering its critics. Today, The Sun have seemingly dropped topless girls from Page 3, largely as a outcome of “No More Page 3” marketing campaign, which is run by a narrow-minded minority who need to spoil the entertainment of the bulk.

As for Palmer, she does not appear to thoughts the attention that she is getting for posing in revealing outfits each whereas working with the UFC and whereas creating her social media content. However, some sports activities have moved away from the spectacle as a outcome of criticism over the objectification of girls. Formula 1 racing for example, abolished the follow of getting grid ladies years ago after facing public backlash. The UFC continues to employ quite a few ringcard ladies or round girls in a tradition that has been seen in boxing and blended martial arts for many a long time. Other sports activities have totally different iterations of the identical, including cheerleaders and other similar ideas. In the submit, she saved her modesty despite being topless by posing sideways whereas crouching near the ground.

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