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Thursday, May 21, 2020
Paano ba ang proseso sa pag aproba ng vaccine o bakuna?
Paano ba ang proseso sa pag aproba ng vaccine o bakuna?
Paano Ina Approve Ang Isang Vaccine?
Pano ba ang proseso bago ito aprubahan.
Pag aaral sa Bagong Bakuna
Ang pangkalahatang yugto ng pagtuklas ng isang bakuna ay:
Yugto ng lahat ng pagaaral sa lahat datos at resulta o pag hahanap ng lahat ng informasyon tungkol sa virus at sa vaccine
Pre-clinical
yugto ng pag develop na ginagawang klinikal
Pagsusuri at pag-apruba ng regulasyon
Paggawa
Pamamahala ng kalidad
Ang development ng pagsusuring klinikal ay isang proseso ng tatlong yugto. Sa panahon ng Phase I, ang mga maliliit na grupo ng mga tao ay tumatanggap ng bakunang pagsubok.
Sa Phase II, ang klinikal na pag-aaral ay pinalawak at ang bakuna ay ibinibigay sa mga taong may mga katangian (tulad ng edad at pisikal na kalusugan) na katulad ng mga nilalayon ng bagong bakuna.
Sa Phase III, ang bakuna ay ibinibigay sa libu-libong mga tao at nasubok para sa pagiging epektibo at kaligtasan.
Maraming mga bakuna ay sumasailalim sa Phase IV
Patuloy na pag-aaral pagkatapos maaprubahan at lisensyado ang bakuna.
Para sa karagdagang impormasyon at upang malaman ang tungkol sa mga bagong bakuna sa abot-tanaw, tingnan ang development process ng World Health Organization (WHO) Development of New Vaccines
Proseso ng Pag-apruba ng Produkto ng Bakuna
Paglalakbay ng isang Bagong Bakuna: Mula sa Pag develop tungo sa pag lilesensya para sa Paggamit
Masusing inaaral kung paano nabuo ang isang virus at ano ang mga katangian neto at kung paano napupuksa ng isang vaccine eto.
(VRBPAC)
Pagsubok sa paggamit ng label ng produkto
Matapos aprubahan ang isang bakuna, patuloy na pinangangasiwaan ng FDA ang paggawa nito upang matiyak ang patuloy na kaligtasan.
Ang pagsubaybay sa bakuna at ng mga aktibidad sa paggawa, kabilang ang mga panaka-nakang inspeksyon sa pasilidad, ay dapat magpatuloy hangga't ang tagagawa ay may hawak ng isang lisensya para sa produkto ng bakuna.
Ang FDA ay maaaring mangailangan ng isang tagagawa na magsumite ng mga resulta ng kanilang sariling mga pagsubok para sa potency, kaligtasan, at kadalisayan para sa bawat bakuna
ENGLISH
Exploratory stage
Pre-clinical stage
Clinical development
Regulatory review and approval
Manufacturing
Quality control
Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
For more information and to find out about new vaccines on the horizon, see the World Health Organization’s (WHO’s) Development of New VaccinesExternal web page.
Vaccine Product Approval Process
Journey of a New Vaccine: From Development to Licensed for Use
See how a new vaccine is developed, approved, manufactured, added to recommended schedule, and is continually monitored.
Journey of Your Child's Vaccine infographic
The U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and ResearchExternal (CBER) is responsible for regulating vaccines in the United States.
The sponsor of a new vaccine product follows a multi-step approval process, which typically includes
An Investigational New Drug application
Pre-licensure vaccine clinical trials
A Biologics License Application (BLA)
Inspection of the manufacturing facility
Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory CommitteeExternal (VRBPAC)
Usability testing of product labeling
After approving a vaccine, FDA continues to oversee its production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.
FDA can require a manufacturer submit the results of their own tests for potency, safety, and purity for each vaccine lot. FDA can require each manufacturer submit samples of each vaccine lot for testing.
To learn about FDA’s role in the vaccine approval process, consult FDA’s Vaccine Product Approval ProcessExternal web page.
Friday, February 14, 2020
CONFESSION OF A TROLL
Confession Of A Troll
William (not his real name) belongs to a relatively new species of media practitioner—the professional troll. That is to say, he is a salaried employee of a legitimate public relations outfit whose job is to run social media campaigns for various clients.
Of course, his job designation doesn’t say “troll”: he could call himself a “social media marketing consultant,” among other things. But a large part of his job involves engaging in internet trolling. And while trolling isn’t the only weapon in his arsenal, it’s proven a very useful one.
Critical factor
A troll is, of course, someone who goes online to pick a fight, for whatever reason: to push a political agenda, to dump on someone he or she dislikes, to vent on a topic he or she feels strongly about, or very often just for the “lulz” (laughs).
In recent years, however, trolling has come to dominate public discourse on social media.
Go online and there’s no avoiding the spectacle of “Dutertards” spitting venom at their real or imagined mortal enemies, the “yellowturds” and vice versa, each drowning out any kind of rational discussion of the issues with the sheer volume (in both quantity and noise level) of their spew.
It’s now generally accepted that social media was a critical factor in deciding the outcome of the last election. What is less clear is why, even after Rodrigo Duterte’s decisive victory at the polls, the online war between his die-hard supporters and more vocal critics hasn’t abated.
If fact, it seems to have heated up even more as pro-Duterte keyboard warriors transition seamlessly from campaigning for him to attacking any and all who dare criticize the newly-elected president or his policies. In particular, Sen. Leila de Lima, the Liberal Party and “traditional media” have been singled out as favorite targets of this troll army.
t’s not only in the Philippines where social media has turned increasingly toxic.
A recent Time magazine cover story titled “How trolls are ruining the Internet” paints a depressing picture of how social media has been overrun by hatemongers of all stripes, from cyberbullies to misogynists, body-shamers targeting fat or unattractive people to racist neo-Nazis and anarchists who are just doing it “for the lulz.”
Could trolling be the new modality for social control?
As analysts have been telling us for years, social media is the new battleground for the hearts and minds of the people, and as in any war, the first casualty is the truth.
In the Babel that is the internet, it is becoming increasingly difficult to sift fact from fabrication in most online exchanges. In the wild and woolly world of social media, any assertion, no matter how far-fetched or outlandish, seems to gain traction as soon as enough people “like” or “share” it: This is what is known as “feeding the troll.”
Someone even came up with an acronym for the content that is increasingly finding its way into social media: DRUMS—
disinformation, rumors, untruths, myths, and smears. Repeated and retweeted often enough, DRUMS can pass for the truth to all but the most critical and analytical minds.
Blissfully unaware
As a functional illiterate when it comes to social media, I was blissfully unaware of most of this.
But as the boundaries between the digital world and “real life” become fuzzier, I feel a nagging sense of dread that, sooner or later, this online negativity would begin to impinge on my world, whether I’m logged in or not.
In order to catch me up on what’s what in this new frontier, I decided to go straight to the source: William the professional troll.
William’s career started quite innocuously a few years ago when he first went on Twitter.
“I became famous on Twitter,” he says, so famous that his feed soon had enough followers for him to be considered an “influencer.”
“You need to have a lot of followers before you can become an ‘influencer,’ like at least 50,000,” he explains. “Influencers are people who set trends on social media. Normally, it’s about artists, celebrities and their fans. But you can make anything trend as long as you control the influencers.”
Because of his online credentials, William was hired by a well-known public relations agency for its social media marketing operations.
Eventually, he says, he became the team leader of a network of influencers.
“We collected as many famous people on Twitter as we could, and we started trending.”
Online buzz
Basically, William was doing social media marketing, developing an online “buzz” around certain brands for local and international clients.
“It’s just like advertising,” he says. “We’re pushing certain brands, and not in a subtle way, through our Twitter posts. And if you have enough posts on Twitter with the same hashtag, it will trend.”
There is a dark side to all this online manipulation, however, and that is trolling.
“In the American context, trolling is getting people riled up and pursuing an argument by posting comments,” he says. “But in the Philippine context, trolling only happens when there’s something like a presidential campaign. That’s the only time trolls become visible as an organized group.
Philippine trolls are like the Dutertards—aggressive, angry, looking for an argument. And that’s the very nature of a troll—
you want to argue, you want to convince people even if you have to lie and fabricate things.”
In short, trolls are there to push an agenda, to propagandize.
Organized effort
William got into trolling in earnest when his firm was enlisted by the camp of one of the candidates in the last presidential campaign. At first it was just like brand marketing, creating a buzz around the candidate, building up his “brand” and his image.
“It’s an organized effort,” he says. “The publicist makes a communication campaign plan. The plan sets the agenda, the objectives, the messaging—
what do we want to say? How do we convince others to agree with us?”
As the campaign heated up and the candidates started duking it out in earnest, troll tactics became increasingly important.
William worked in one of several clusters scattered throughout the country, headquartered in a suite of rented rooms.
It was set up like a call center operation, he says. Each day, the team leader would put up a board on which was listed the most recent posts with the most “likes” and “shares” which had to be responded to. The appropriate response—carefully worded by the team’s designated writer
—would likewise be put up on the board. And the “keyboard warriors” would start posting responses to the targeted posts, usually by merely copying and pasting the prepared response.
We really worked at it, 24/7,” recalls William. “But the pay was very good. You could earn P2,000 to P3,000 a day just doing copy-paste.”
Dummy accounts
Social media is a numbers game, and each keyboard warrior used several dummy accounts to make their posts. Some attention is paid to creating believable online personas and backstories for these accounts, says William, from the generic “concerned netizen” to “struggling OFW,” for instance.
“The real accounts are submerged by the trolls,” he says. “If I’m a troll and you are a legitimate commenter, and I convince you to fight for my cause, you become one of my keyboard warriors, as well. Even if you are a real person with a real account, if we convince you, you become part of the organism. You become a servant of the ideology that these fake trolls have injected you with.”
William’s experience does nothing to allay any fears the more conspiracy-minded among us might have.
“It’s social media mind conditioning,” he says. “Our public relations firm was working with a psychologist—a famous psychologist from UP. He really knows how to mind-condition the people, how to make lies seem like the truth, fabricated stories into fact. And the trolls spread it like rumor or gossip. You inject it into the real accounts, the real accounts will believe you and spread it to other people, and so on.”
“It’s like ‘The Matrix’—you don’t know who’s real and who’s not,” he adds. “Unless you’re a very good identifier.”
Booming business
One way, he says, is by engaging the suspected troll.
“Most trolls can’t argue—that’s one of their weaknesses,” he says. “Most of the time they can only copy-paste ready-made statements to synchronized topics; they don’t really have the minds to argue with you.”
Trolls also tend to follow influencers like drones follow the queen bee, he adds. Kill the queen bee and the drones die off, too.
You can also configure your Facebook or other social media account to filter out or block obvious trolls.
If that sounds like a lot of work, you can simply unplug, but that won’t really change anything. In fact, says William, business for professional trolls is likely to boom.
“Whoever is planning to run in 2022 should invest now,” he says.
By: Eric S. Caruncho
How Troll Can Make Duterte look like Superman
Troll farms are being funded through Malacañang’s P4.5 billion intelligence funds in the 2020 national budget. Intelligence funds are opaque in nature and are not covered by audits.
Office of the President putting the P2.5 billion ‘intelligence funds’ to work,” one Facebook user claimed.
In a white-walled room, a small cyber-army of four is furiously typing. And posting. And clicking. And scrolling. And trolling.
For the next eight hours, they will be glued to their screens. They have hired guns in one of Manila’s hundreds of troll farms churning out fake content, false narratives and anything else the client wants.
This trolling mission was for a politician or politician wannabes
One aim was to cook up fake social media accounts to make it appear as if the candidate had a vast and fervent base of supporters. Another goal was to smear any critics, especially those who call them out for precisely the jobs they do.
Across the Philippines, it’s a virtual free-for-all. Trolls for companies. Trolls for celebrities. Trolls for liberal opposition politicians and the government. Trolls trolling trolls.
The world of Internet trolls — the gaslighting, the fabrications, the nastiness — is now a fact of life in the Web ecosystem nearly everywhere.
But something new is happening here: Experienced public relations experts in the Philippines are harnessing the raw energy of young and aggressive social media shape-shifters.
How social media companies outsource their dirty work to the Philippines
They are dramatically altering the political landscape in the Philippines with almost complete impunity — shielded by politicians who are so deep into this practice that they will not legislate against it, and using the cover of established PR firms that quietly offer these services.
It is also showing signs of going global — with the Philippines as a hub — as the United States and countries across the world move into another election cycle in the troll age.
“This is what disinformation will look like in the U.S. in 2020,” said Camille François, chief innovation officer at the New York-based social network analysis company Graphika.
AD
Political manipulation, she said, does not need to come from an ill-intentioned enemy state. It can originate with those who have cut their teeth in the competitive worlds of advertising, media, and marketing. Social media companies, she added, were caught off guard before — notably in the U.S. presidential election in 2016 — and could be yet again with this new iteration.
“The Philippines shows us trends that are headed this way,” said François, who led a report commissioned by the Senate Select Committee on Intelligence investigating Russian trolls in the United States. “And, it is 2019, the market is global — so they will find jobs outside of their own nation.”
Facebook’s second-class workers are waging a quiet battle
These ambitious operators now want to turn their country into the go-to place to influence corporate and political campaigns worldwide — using the same young, educated, English-speaking workforce that made the Philippines a global call center and content moderation hub.
What is clear is that the Duterte government has appointed several bloggers and social media personalities in the government’s communications department. It even gave media accreditation to some pro-Duterte bloggers. Unfortunately, some of these bloggers have been accused of peddling fake news and spreading hateful comments against critics of the Duterte government. Some are criticized for behaving like trolls especially those who think that members of the media are too biased against Duterte.
Responding to the Freedom House report, the Presidential Communications Operations Office (PCOO) said it does not employ a “keyboard army.”
Indeed, many of these supporters are also using the Internet to defend Duterte. Their blind loyalty to Duterte and their aggressive online behavior against government critics are derided as symptoms of being a “Dutertard” (not to be confused with Dotard).
Is there a state-backed “keyboard army” in the Philippines? If anything, the Freedom House report and the earlier study of Oxford should compel Congress to probe if government funds are being used to manipulate information.
Though not all “Dutertards” may be trolls, the public has the right to know if the state is funding the activities of a “keyboard army” which is trolling citizens opposed to Duterte’s war on drugs. Some of these pro-Duterte trolls have become notorious for using fake accounts to harass and attack netizens, journalists, and opposition politicians.
Duterte proved that he understood the changing media landscape when he hired an online team to enhance his winning chances in the 2016 election. As a veteran politician, he is also aware of the importance of delivering his message effectively to strengthen popular support for his government.
Recently, he named a new spokesperson, which indicated that he felt dissatisfied about how his policies are being explained to the public. Though no messenger will be able to convince the public that the war on drugs is succeeding or that it is upholding life and human rights, the naming of a new spokesperson could also mean that the government is open to rethinking its propaganda strategy.
Perhaps Duterte can be persuaded too that the alleged continuing existence of a “keyboard army” is not helping him earn credibility among Internet users. Or that an army dedicated to the spread of fake news, hate speech, and online violence can only lead to greater disunity, cynicism, and low public confidence. Unless of course, he relishes the idea of being called the Philippines’ “troll-in-chief.”
from the article of:
Catalina Ricci S. Madarang at Regine C
Friday, September 13, 2019
Traffic Solution Without Emergency Powers
It is supply and demand. Supply is basically the road capacity how much car
carrying ability or capability we have on our road system, the demand is
basically, all of us want to use that capacity so when all of us overwhelm the capacity we get congestion.
Traffic engineers don't solve problems they just move them to another place.
Traffic engineering is chasing its own tail because when we make an improvement what happens more people want to come and use that
because we've increased speeds we've cut down travel time so more people want to come and we end up in the same situation that we were, to begin with
The real culprit? Cars
Private cars are filling our city and they're taking up more and more parking spaces. It doesn't make a ton of sense so we have to build more parking spaces and that precious space we have goes to the
cars instead of to other things people spend millions of hours every year stuck in traffic.
Over the past ten years, private car growth has grown by
50% during that same time population has grown by just 7%
So the problem is getting worse every month every year.
Solution? Ride-sharing to help solve some of the problems we are facing
No private cars can use EDSA if it carries only the driver.
Strict implementation must be enforced even after the car leaves the parking lot. No car can leave the parking lot if the car carries only the driver. It can be monitored via CCTV cameras of all parking areas in Metro Manila.
The car can only exit the parking area if the car has at least 1 passenger aside from the driver on board. That's how you sacrifice a little for the comfort of having your own car. At least the payback is, you get to drive a less congested road because everybody else is doing what you are doing.
Carpooling service must be strictly imposed.
Cars should be full and most importantly it is great for the city
because the city now had fewer cars on the road and there is less congestion not to mention fewer pollutions too.
Solution2. Prioritize Public Transport. Because public transport carries more people at a given time. Added lane should be attributed to the masses.
After all the private vehicles experience less stress inside their airconditioned cars than the sweaty riding commuters. Commuters help build the country's economy.
Solution 3- Reduce car ownership. There should be a limit to total cars to be sold in a month. It can be monitored by car dealership. Car dealers earn millions and millions every year. Limitations would probably not make any dent from their earnings.
Solution 4. Companies must provide " Work buses" for their employees.
Works buses
Where a company puts on a works bus service, this will often compete with and undermine the viability of public services. Therefore it is far preferable (and probably cheaper) for the company instead to subsidize public services for the hours or frequency needed to make it serviceable for their workers. Hopefully, the Bus Services Bill will make this kind of arrangement easier to organize.
Solution 5.
Charge for workplace parking
Free parking at employment sites attracts traffic and therefore contributes indirectly to congestion. In other Countries, they led the way in introducing a workplace parking levy (WPL). The effect on congestion is relatively small but significant. More importantly, it incentivizes employers to help their employees find alternative ways to get to work. Measures may include:
Re-allocate car parking for cycle parking
Set up or join a car-share scheme
Pay for taxis as a back-up when car-sharing does not work out
Provide financial assistance (e.g. loans) to buy train or bus season tickets
Build a changing room and showers.
Assist with subsidizing public bus services to extend the hours of operation
Where there is no (nearly) suitable public bus service, run a works bus.
Solution 6 Optimise traffic-light management
Urban Traffic Management Control (UTMC) systems such as SCOOT can be very effective in maximizing road capacity by varying the timing of traffic lights to match demand in real-time. When lights are all co-ordinated responsively to demand, incidences of ‘blocking back’ (vehicles stuck in junctions) leading to gridlock can be minimized. Traffic planners can also prepare and model programs to cope with specific scenarios (such as an incident on an arterial road), which can then be loaded into the UTMC immediately they’re needed.
UTMC can help prioritize buses by synchronizing light phases to the movements of buses. Modern systems can even see whether a bus is running on or behind schedule, and vary the amount of priority it gives accordingly (e.g. by limiting green time from crossroads).
The non-linearity of the relationship between traffic ‘flow’ and ‘delay’ means that relatively small reductions inflow (say 10-15%) can result in very large reductions in congestion. In Cambridge London this is experienced as a ’half-term effect’: flow reductions of under 15% during school holidays lead to an almost congestion-free peak hour.
For this not to be portrayed as a “war on motorists”, we must find ways to filter motor vehicles so as to deter people from driving who have alternatives, but without severely inconveniencing those who, for personal or business reasons, have no alternative. Transport professionals must adjust the way they refer to people, not as ‘motorists’ or ‘cyclists’, but as people who drive, cycle, walk, take a bus, etc. Change is not a zero-sum game: someone’s gain is not necessarily someone else’s loss: we all stand to gain from having more travel options.
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