12/30/2023 0 Comments Ema start time![]() ![]() Selection Criteria – Not all medicinal products may benefit from PSA. The HTA Coordination Contact will notify the company and the EMA about the outcome of the selection within 4 weeks. Request for Participation – Companies can apply for PSA from September 2023 until January 2025, by submitting an application form and its annexes to the EMA and the HTA Coordination Contact. ![]() ![]() HTA Coordination Contact – The G-BA (Gemeinsamer Bundesausschuss/Federal Joint Committee, Germany) is designated as the HTAbs Coordination Contact for centralized recruitment and practical coordination of participant HTAbs.Īssociated Experts – The EMA or the HTAbs may decide whether to involve healthcare professionals/clinical experts and patient representatives in their respective assessments. If fewer than two HTAbs are available after the selection process, the PSA continues as a simple regulatory-only EMA scientific advice.Ī company may not choose the HTAbs to be involved in its PSA. If an HTAb decides to participate, it may do so either (i) as an active participant, providing advice based on its national HTA requirements, or (ii) as an observer.Ī minimum of two active HTAbs is required for each PSA. HTAbs – National HTAbs may, at their discretion, participate or not in a PSA. The EMA and the HTAbs have specific roles and responsibilities.ĮMA – The EMA participates in the PSA through its Scientific Advice Working Party (“SAWP”), which provides general, regulatory-only scientific advice (advice on tests and trials necessary to demonstrate the quality, safety, and efficacy of medicinal products) when only the EMA is involved. Like the previous parallel scientific advice schemes, the interim PSA will provide scientific advice on initial evidence generation so that pharmaceutical companies can design their trials and generate data to adequately support not only their marketing authorization applications but also their pricing and reimbursement applications and Post Licensing Evidence Generation (“PLEG”). The Guideline in essence provides for a new pilot but on a rolling basis for about 16 months. Since then, parallel scientific advice has been replaced by pilot applications of the HTA Regulation, each with a limited application period. It was set up about 10 years ago on an informal basis, regularly evolved, and largely contributed to the adoption of the HTA Regulation. Parallel or joint EMA-HTAb scientific advice is not new. In November 2022, the Heads of Medicines Agencies (“HMA”) launched the second phase of their pilot project on simultaneous national-level scientific advice. ![]() In February 2023, the EMA organized a pilot project for high-risk medical devices by the expert panels created by the Medical Devices Regulation (“MDR”). Generally, opportunities to receive scientific advice are increasing in the EU. It explains the eligibility criteria, timelines, and procedure, as well as the role and responsibilities of each participating party. The Guideline organizes parallel scientific advice (“PSA”) by the EMA and national health technology assessment bodies (“HTAb”) on a rolling basis, for the period between September 2023 and January 2025 when the European Union (“EU”) Regulation 2021/2282 on health technology assessment (“HTA Regulation”) becomes operational. On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”). ![]()
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12/30/2023 0 Comments Spy cam voyeur hot![]() Seafood imports from other prefectures are allowed but must be tested for radioactivity. Japan's foreign ministry declined to comment on the possibility of more bans but said Japan had sought scientific discussions with China on the release and would continue to do so.Ĭhina bans seafood imports from 10 of Japan's 47 prefectures, including Fukushima and the capital Tokyo, and all food and feed imports from nine of them. but for Japan this is a big market."Ĭhina's foreign ministry said on Thursday Japan did not fully consult the international community on the release and China would pay close attention to developments and would assess any possible effects to protect consumers. "For China, Japanese maritime product imports make up a small share of their market. "They want to punish Japan economically for this." "We think they may enforce a total ban on Japanese maritime products," one of the officials said. Two of the officials said that could include a blanket ban. Three Japanese government officials and a ruling party lawmaker, speaking on condition of anonymity given the sensitivity of the issue, said they expected China to expand restrictions on Japanese seafood. ![]() The release is due to start in coming weeks and take up to 40 years. The planned release of the water from the plant north of Tokyo has faced opposition at home and abroad despite Japanese assurances that it is safe after being filtered to remove most isotopes.Ĭhina was the biggest buyer of Japanese seafood exports last year, even though it is among several countries that restrict imports from some Japanese regions because of the nuclear accident.Ĭhina is also the fiercest critic of Japan's planned release of the water saying it threatens marine life and human health.Ĭhina has not said what action it will take if the release goes head but it has warned Japan that it must "bear all the consequences" of its action. nuclear watchdog this week gave Japan the greenlight to begin discharging more than a million metric tons of water, enough to fill 500 Olympic swimming pools, used to cool the plant's fuel rods after it was wrecked by a 2011 tsunami. TOKYO/BEIJING, July 6 (Reuters) - Japanese officials are worried that China, the biggest buyer of its seafood exports, may halt purchases of those items after Tokyo begins releasing treated radioactive water from its crippled Fukushima nuclear plant into the sea. ![]() 12/30/2023 0 Comments Bucks roster 2023![]() While he’s 35 years old, Lopez showed this past year that he still has plenty left in the tank. It would be hard to find a center that complements the Big 3 of Giannis Antetokounmpo, Jrue Holiday, and Khris Middleton better than Lopez has over these past few years. On the court, Lopez is an excellent fit for the Bucks, as his defense down low is tremendous, and he can score and shoot the ball extremely well on the other end. ![]() Back in January, HoopsHype’s Michael Scotto asked Lopez about his time with the Bucks, to which the center replied, “I can’t imagine being anywhere else.” Of course, things can always change, but it seems likely that the Bucks and Lopez will have plenty of interest in continuing their partnership and that a new deal will come quickly this off-season. Unsurprisingly, it seems that Lopez has an interest in sticking around with the Bucks as well. Coming off his best season as a Buck, where he finished second in the Defensive Player of the Year race and put up his most points per game since 2016-17, it’s not too far-fetched to say that Milwaukee should be all-in on keeping the big man around. Although Robin isn’t expected to have a sizable role, his presence gives Milwaukee. Retaining Brook Lopez will be among the top priorities for the Bucks as he braces for unrestricted free agency this off-season. The Bucks also added some size to their roster with the addition of Brook Lopez’s twin brother, Robin. With that said, let us do our best to predict where each of Milwaukee’s 10 free agents will be playing next season. Of course, some players are likelier to return than others, but at this point, there’s no telling where everyone will end up. ![]() The Bucks have 10 players eligible to hit the open market, and due to the team’s limited spending money, some cuts will have to be made. With 2023 NBA Free Agency on the horizon, the Milwaukee Bucks will have some tough decisions to make regarding their roster. ![]() 12/30/2023 0 Comments Strafer mk4 police![]() ![]() More details will be posted as we get closer to the event dates. We would like to invite you to visit us our booth and see our products while you are attending these events. X-Caliber Tactical will be attending the 2009 SHOT Show (booth 3290) and the 2009 OLTEC Mock Prison Riot. X-Caliber Tactical is pleased to announce the availability of new products, including Ear Protection, Eye Protection and Laser Sights. X-Caliber Tactical is pleased to announce the availability of EOTech Sights and Surefire Flashlights.įrom Novemthrough January 04, 2009, we're offering a 10% Off Sale on the Strafer MK4 Mod 0 Less-Than-Lethal Weapon. There are some technical errors, but it but makes for an interesting read none the less! Writer David Fortier met us at SHOT Show 2008 and reviewed the airsoft Real Sword Type 97 and 97B. 29, 2008 issue of Shotgun News on page 18. We'll have the Minigun and several other airsoft examples. We will be at Booth 3290, and we welcome all attendees to visit us there. 15-18 at the Orange County Convention Center in Orlando, FL. We will be exhibiting at SHOT Show 2009, Jan. X-Caliber Tactical is pleased to announce the availability of Insight Tech Gear. X-Caliber Tactical and the Strafer are featured on Defense Review in an article dated entitled " P3 Strafer MK4 Mod 0 Less-Lethal Machine Gun/Weapon System". X-Caliber Tactical is pleased to announce the availability of Trijicon products. X-Caliber Tactical is pleased to announce the availability of Aimpoint products. We've posted a new Airsoft training video on the main Airsoft page. X-Caliber Tactical is pleased to announce the availability of the new Pipers Precision Products RSG-2. The article can also be seen at the Guns and Weapons Online site. X-Caliber Tactical and the Strafer Mark 4 Model 1 will be featured in in the September 2009 issue of Guns and Weapons for Law Enforcement in an article entitled Alternative Force Weapons. We also will be attending the NTOA Conference in Tulsa, OK September 13-18, 2009. X-Caliber Tactical will be attending Trexpo East in Chantilly, VA August 19-20, 2009. SOCOM Gear Airsoft AEGs and Airsoft Spring Rifles.Echo 1 Airsoft AEGs, Airsoft Support Weapons, and Airsoft BBs.X-Caliber Tactical is pleased to announce the availability of the following product lines: E-mails and phone calls will be answered as quickly as possible upon our return.įrom Novemthrough December 25, 2009, we're offering a 15% Off Sale on the Strafer MK4 Mod 0 Less-Than-Lethal Weapon. We will be at booth 25501, and we welcome all attendees to visit us there. 19-22 at the Sands Convention Center in Las Vegas, NV. We will be exhibiting at SHOT Show 2010, Jan. Hakkotsu Soundflash Style Spare Shell for Thunder B Sound Grenade.Thunder B CO2 Sound Effect Airsoft/Paintball Simulation Grenade.X-Caliber Tactical is pleased to announce the availability of the following products: X-Caliber Tactical is pleased to announce the availability of Duostock products. Our 15% Off Sale on the Strafer MK4 Mod 0 Less-Than-Lethal Weapon has been extended until January 16, 2010. E-mails and phone calls will be answered as quickly as possible upon our return. We have the Minigun and several other airsoft examples on display. We are at booth 25501, and we welcome all attendees to visit us there. We are exhibiting at SHOT Show 2010, Jan. X-Caliber Tactical is pleased to announce the availability of Mil-Spec Monkey patches and bracelets. Check it out on our M134A2 Vulcan Minigun page.Ģ5 new photos have been added to the RSG-2 product page, including several from the 2010 SHOT Show. It has never been fired, and has been stored in a gun safe by the original owner. We have a certified pre-owned Airsoft M-134A1 Vulcan Minigun available for sale. ![]()
12/30/2023 0 Comments Southwest denver to atlanta![]() Near to the downtown home of the Atlanta Falcons, you can also find big-name attractions like the The Georgia Aquarium, World of Coca-Cola and the Center for Civil & Human Rights. Big names include The Atlanta Braves, Atlanta Hawks and Atlanta Falcons, but the region recently added the city’s first MLS team Atlanta United F.C. Home to five professional sports teams and many college teams in the area, Atlanta offers a growing audience of sports fans and hosts many college and professional sporting events throughout the year. Discover craftsmanship in the city’s shops or stop in for something more eclectic, the massive DragonCon multigenre convention that takes over downtown Atlanta on Labor Day weekend. Enjoy the city’s stunning beauty through it’s growing collection of street art, supported by the annual Living Walls event and organization. Even swing by for a music festival like JazzFest, the city’s large and free summer jazz festival. Listen in at ATL music venues, like the Tabernacle, The Drunken Unicorn or Eddie’s Attic. You can enjoy Midtown favorites like the High Museum, Atlanta Symphony or the Museum of Design Atlanta. ART & CULTUREĬreatively, Atlanta doesn’t just leave a mark on you, but lets you leave a mark on it. And of course, don’t skip the city’s beloved Staplehouse - a for-profit subsidiary of The Giving Kitchen, a non-profit that assists Atlanta restaurant workers in times of need. ![]() For fine-but-casual dining, try any restaurants from renowned regional chefs Anne Quatrano, Hugh Acheson or Ford Fry. In the morning, sample any of Atlanta’s biscuit-laden brunch hotspots. Take a trip to Buford Highway to find authentic Korean, Vietnamese, Cantonese and Sichuan. Start casual, and wander the halls of the big eating houses in Ponce City Market or Krog Street Market. Southern culture has always had food at its heart, and regional cuisine has been rethought and refreshed through Atlanta’s dining scene. ![]() Wherever you wander, you’ll find something to enjoy. For nightlife, explore the Highlands, Edgewood or Atlanta’s quirky “EAV” or East Atlanta Village. For great eats, try Old Fourth Ward, Kirkwood, Decatur or Atlanta’s Westside. ![]() Start your stay in Midtown, home to many of the city’s hotels, Georgia Tech University and the city’s tree-filled Piedmont Park. When you fly to Atlanta, you will find a patchwork of neighborhoods, many dotted with Atlanta’s signature early to mid-century homes. Always changing, the city’s experiencing a vital stage of growth - with jobs and people rushing into the city’s neighborhoods, each one with its own unique feel. There’s many ways to describe Atlanta, and much more to see. Unexpected, artsy, urban, Southern, a little quirky, real, still finding its identity. ![]() ![]() ![]() Our narrator will guide you through the game’s foundational skills, like building your economy and entering combat, whilst you help a group of displaced villagers start anew. Head to the “Learn” tab in the opening menu to find our Intro Tutorial.If you’re new to Age of Empires: first of all, welcome! Now that you’re with us, there’s plenty of ways for you to get started: With eight diverse civilizations, four captivating campaigns, multiplayer, skirmish, maps, unlockable videos, Art of War challenges, masteries and more, we’re excited to see what you play first. ![]() For those in London, heading to Piccadilly Circus from November 2nd could be an experience for the ages.Īge of Empires IV has something for every strategy gaming fan. Please share your experiences if you happen to be in NYC. To celebrate the launch of Age of Empires IV, we are taking over Times Square in NYC by spanning multiple city blocks of large digital screens, a living diorama, and an AR experience. Players all over the world have been engaging in fierce battles, building expansive empires, and wololo-ing for close to 25 years and it’s thrilling to give our players more to enjoy. This is the first new numbered Age of Empires title in 16 years, and we’re honored to have added a chapter to this globally beloved franchise. The whole team is so proud to announce that Age of Empires IV is now available on Steam. The day is upon us, the sun has risen on a new Age. Emma Bridle, Director of Customer Voice, World’s Edge ![]() 12/30/2023 0 Comments Cheapest material to cover wall studs![]() ![]() Reasons to Choose Metal Studs Over Wood Studs These may include a table saw, nailer, common nails, hammer, drill and screws to secure the studs properly. In the case of a wood stud, several tools are required at the time of installation. Difficult To Install: It is way more difficult to install a wooden stud as compared to a metal stud.Although a few soft woods are not as expensive as hardwood, the comparative cost between metal and wood studs has changed over time There was a time when would was economical. Expensive: Currently, wood prices are way up and can be more expensive than metal.Rot And Warp: Wood studs can be compromised when exposed to water and humidity.Depending on the nature of the construction project, here are a few of the factors that should be considered while making a choice: Wood is not a suitable material for all kinds of building projects. There are some disadvantages when using wood for your studs. It all depends on the level of quality that one desires. ![]() However, it is still possible to come across studs that are made from hardwood or perhaps cedar. ![]() Most projects do not require anything bigger than the typical standard sizes. These are also called light structural lumber. These types of wood studs are typically constructed from softwood trees. You may come across something as small as 2 x 4 or 2 x 6 inches or something as big as 2 x 8 inches. When it comes to wooden studs, there are a lot of varieties available.
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Now through 4/30, CVS has select Schick or Skintimate razors on sale for $8.99. ![]() 12/29/2023 0 Comments Arched full length mirror![]() ![]() The frame on the mirror is enough to make this mirror pop when hanged on the light home wall. ![]() Simple design & compact frame & strong backboard endow the mirror anti-water, shockproof, more stable & longer working life.Ģmm thick fingerprint-proof stainless steel frame+upgraded no-distortion 4MM HD mirror to deliver clear reflection+TSCA certified backboard, same level material for Five Star Hotel.Ģ0 years production experience with more than 50 steps processing of a finished mirror ensure surface evenly colored, smooth, corrosion-resistant, anti-fingerprint & prevent scratching.Īmazingly versatile, our gold frame mirror are popular in modern, traditional and maximalist designs. With a gorgeous gold border, this round corner mirror is love at mirror balances out simple, tasteful styling with a throw, pops off the white walls for a scene-stealing burst of warmth and shine.Ī black frame goes will with everything. If you're into brighter, airier spaces, go with an all-white room and incorporate small infusions of black. To ensure your home safety, we used four metal hanger ring that are securely welded to the back of the metal frame, which sit on top of the frame for easy hanging. Upgraded 4MM HD polished mirror is presenting a beautiful reflection without any distortion of visual, adds light, and enhances the beauty of any room in your home instantly. It pairs well with Hollywood Regency, mid-century modern, glam and even modern farmhouse decor.This full-length mirror features an arched silhouette and ultra-thin frame, complements all your home decor, and brings your room style and elegance. 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Shop Gloss Arched Floor Length Mirror 36x76. ![]() 12/29/2023 0 Comments Womens cool graphic tees![]() ![]() Shop cheap graphic tees on our site or check out our new arrivals for the hottest clothing, shoes, and accessories. ![]() If you want to make a statement, choose a graphic shirt with a bright colour.įor a cool, off-duty look this season, our edit of women's graphic t shirts has you covered. We also have tees in a selection of colours from edgy black graphic tees to fresh white graphic tops for summer. You can also team it with a satin midi skirt and fresh white sneakers for a pared-back look.ĭiscover different styles in our collection, including cropped, oversized, and graphic sweaters for the cooler months. Graphic Tees for Women: Band, Vintage + More Urban Outfitters. Browse for classic band tees and quirky prints in a huge range of colors, cuts and materials to work with every look. 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