powerpoint presentation about internet safety

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Resources for parents, educators & communities.

NetSmartz: Online Safety for Middle School

Advanced Online Safety for High School

Internet Safety: Parents, Guardians & Community

Our resources for educators offer multiple ways to engage students, parents and communities in important lessons in digital citizenship and online safety. 

Empower your students to be safer online with our   free collection of teaching materials for families and students in grades K-12.  NetSmartz can help you create a dynamic and engaging Internet safety curriculum.

PowerPoint Presentations

NetSmartz offers free, multimedia internet safety presentations tailored for specific audiences — parents and communities, teens, tweens, and younger children. Our innovative presentations make use of online resources, videos, and expert tips to educate, engage, and empower children and adults to be safer on and offline.​

The presentations below are categorized by age of the intended target audience. However, we strongly encourage presenters to review the PowerPoint presentations before deciding which one to use and to consult with the hosts of your presentation (e.g. administration and/or support staff if presenting at a school) to select the most appropriate presentation for your audience. Depending on your audience’s previous exposure to internet safety and related topics, you may need to deviate from the age guidelines given below to find the most relevant information and format. Contact us at [email protected] with questions or for assistance.

For useful tips and recommended strategies for planning and delivering child safety presentations, be sure to check out the free trainings available on NCMEC Connect!

K-12 Google Slides by Topic

Teaching Modern Safety with "Into the Cloud" Season 1 Grades K-2

Teaching Modern Safety with "Into the Cloud" Season 1 Grades 3-5

Teaching Modern Safety with "Into the Cloud" Season 2 Grades 3-5

Be Safer Online with NetSmartz: Grades K-2 (PC/Mac)

Being a Good Digital Citizen: Grades 3-5 (PC/Mac)

Written for tweens, teens, parents, educators, and law enforcement, these tip sheets offer guidance on navigating digital safety.​

Sextortion: What Parents Should Know

Being a Trusted Adult

Gaming Safely

Internet Safety at Home

So You Need Some Help...

Who is a "Trusted Adult"?

"Your Photo Fate" Video Discussion Guide

Cyberbullying Unplugged

How Do You Use Your NetSmartz? Tips for Teens

Parents' Guide to Smartphone Safety

Protecting Your Kids Online 2.0

Social Media Safety for Teens

Talking to Teens About Sexting

Think Before You Send

Your NetSmartz: Tips for Tweens

You Sent a Sext, Now What?

Classroom activities.

Additional material for the classroom, tailored for project-based learning and children with special needs.

Film Discussion Guide: What is Sextortion?

Film Discussion Guide: The Story of S.M.

Film Discussion Guide: The Story of H.M.

Peer Education & Mentoring Kit

Safety Pledges Using SymbolStix

Safety Stories

E-book: Delivery for Webster

E-book: The Princess's Password

E-book: Webster's Gecko Goof

Free online, on-demand trainings related to prevention education are available via NCMEC's online training portal, NCMEC Connect. View webinars, recorded live sessions, resources and best practices covering online exploitation, tips for teaching online safety, parent/guardian specific topics, and more! 

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Internet Safety & Digital Citizenship�Awareness and Education

Larry Magid

Co-director, ConnectSafely.org

Founder, Safekids.com

CBS News/CNET

Lynette Owens

Director, Corporate Outreach

Trend Micro Internet Safety for

Kids & Families Program

• Internet safety and Digital Citizenship

Trends and Implications

• Recommendations

Internet safety vs. Digital citizenship

• Internet safety /Media literacy:

help kids understand online risks and how to respond

• Digital citizenship :

teaches kids to act responsibly around other kids; eliminates biggest threats of being harmed by other kids or themselves

• Viewing inappropriate content
• Posting inappropriate content
• Cyberbullying & harassment
• Online addiction
• Online contributing to destructive, illegal, unethical or inappropriate behavior
• Device security & social engineering tactics

What parents tend to worry about

• Physical safety – freedom from physical harm
• Psychological safety – freedom from cruelty, harassment, and exposure to potentially disturbing material
• Reputational and legal safety – freedom from unwanted social, academic, professional, and legal consequences that could affect you for a lifetime
• Identity, property, and community safety – freedom from theft of identity & property

Types of Internet safety

How the Internet changes the equation...

• Persistence & searchability: Net as permanent searchable archive
• Replicability: ability to copy and paste from anywhere, to anywhere
• Scalability: high potential visibility
• Invisible audiences: you never know who’s watching
• Blurring of public and private: boundaries not clear

AND WE ADD IN:

• Disinhibition : Lack of visual cues reduces empathy

Source: danah boyd: Taken out of Context, 2008

The Net Effect

Sexting and cyberbullying on the rise

Bullying declining

Child identity theft on the rise

Cybercriminals increasingly active on social web

• Children & teens frequently victims of identity theft
• Youth need to be aware of social networking scams
• Teach youth to protect their passwords
• Youth implicated in hack attacks
• Teach security by teaching critical thinking
• Ensure schools and parents use available technologies

Security and Youth

Levels of Internet safety

• More training in "norms theory.”
• Use of "whole school" approach to bullying and other behavioral issues.
• Acceptable use policies that are up-to-date, reflective of today’s technology and uses of it.
• Regular, updated training of staff, students.
• Collaboration with PTO/PTA and families of students.

Some Recommendations

Some Resources

ConnectSafley.org

NetFamilyNews.org

SafeKids.com & SafeTeens.com

Trend Micro Internet Safety

Common Sense Media Educators

Internet Safety Technology Task Force Report

Directory of Internet safety sites & resources

Directory of Internet safety curricula

Internet safety by age levels

Young People and the Internet

-Nielsen Netview, October 2009

Top Web properties visited by U.S. youth ages 2-17

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Top 10 Internet Safety PowerPoint Presentation Templates in 2024

Our Internet Safety presentation template is a comprehensive and visually engaging tool designed to educate and raise awareness about the importance of online safety practices. With fully editable and customizable slides in PowerPoint, this template covers a wide range of topics such as protecting personal information, recognizing online threats, safe social media usage, and tips for secure online transactions. Ideal for schools, businesses, and community organizations, this template can be used for training sessions, workshops, or awareness campaigns aimed at audiences of all ages. The eye-catching design and clear layout make it easy to convey critical information about internet safety in a memorable and impactful way. Whether you are a teacher, HR professional, or community leader, this template will help you effectively communicate the importance of staying safe and secure in the digital world.

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• Security Lock

Safety And Security Powerpoint Ppt Template Bundles

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• Safety Measures At Construction Site
• Security Breaches
• Cyber Security Tracking
• Workplace Safety
• Security Threats

Safety Strategy Powerpoint Ppt Template Bundles

Deliver a lucid presentation by utilizing this Safety Strategy Powerpoint Ppt Template Bundles. Use it to present an overview of the topic with the right visuals, themes, shapes, and graphics. This is an expertly designed complete deck that reinforces positive thoughts and actions. Use it to provide visual cues to your audience and help them make informed decisions. A wide variety of discussion topics can be covered with this creative bundle such as Online Payment Safety, Corporate Network Safety, Consumer Safety, Digital Safety Strategy, Employee Health And Safety, Workplace Safety. All the twenty six slides are available for immediate download and use. They can be edited and modified to add a personal touch to the presentation. This helps in creating a unique presentation every time. Not only that, with a host of editable features, this presentation can be used by any industry or business vertical depending on their needs and requirements. The compatibility with Google Slides is another feature to look out for in the PPT slideshow.

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• Online Payment Safety
• Corporate Network Safety
• Consumer Safety
• Digital Safety Strategy
• Employee Health And Safety

Digital Safety Powerpoint Ppt Template Bundles

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• Digital Security Compliance Standards
• Online Security Pain Points
• Digital Safety Risk Assessment
• Online Safety Training Program
• Internet Security Awareness
• Digital Food Security
• Internet Safety Policy
• Digital IOT Devices

Cyberspace technology networking interconnected communication

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• Interconnected
• communication

Mobile security connection protection features secured network

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• Mobile Security

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• Information Security
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• Services Compliance
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NetSmartz Internet Safety [web resource] [downloadable] [video]

NetSmartz covers the following issues , each of which has accompanying resources:

• Cyberbullying
• Online Enticement

Video Series

Into the Cloud™ is NCMEC’s flagship online safety product for children ages 10 and under. Using data from actual CyberTipline reports, each episode of season 1 focuses on a different element of online safety, from strategies for handling cyberbullying to recognizing and reporting unsafe/inappropriate interactions and content.   Season 2 focuses on preventing online exploitation, reporting, and removing inappropriate content online.

Educator Resources

Resources for educators offer multiple ways to engage students, parents and communities in important lessons in digital citizenship and online safety.

Presentations

>NetSmartz also offers free, multimedia internet safety presentations tailored for specific audiences — parents and communities, teens, tweens, and younger children. The presentations make use of online resources, videos, and expert tips to educate, engage, and empower children and adults to be safer on and offline.​

Written for tweens, teens, parents, educators, and law enforcement, downloadable tip sheets offer guidance on navigating digital safety.​

Project-Based Learning and Special Needs

NetSmartz also provides material for the classroom, including some tailored for project-based learning and children with special needs.

Source: National Center for Missing & Exploited Children | NetSmartz | Copyright © 2024 National Center for Missing & Exploited Children. Retrieved July 2021. Last reviewed April 2024.

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With advancing technology, the internet has become an integral part of our daily lives. However, this increased connectivity also exposes us to various risks, such as cyberbullying, online scams, identity theft, and other security threats. Get our Internet Safety presentation template for MS PowerPoint and Google Slides to depict the practice of using the internet in a responsible manner to protect our personal information from potential harm.

Cybersecurity experts can use this fully customizable deck to exhibit the internet safety rules and tips that people must follow to create a safer digital environment. You can explain that internet safety includes various practices like using strong passwords, evading suspicious websites, and being mindful of the content shared and received online. You can also exhibit examples of appropriate online behavior and healthy digital habits in an easy-to-understand manner.

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23 Great Lesson Plans for Internet Safety

Topics:   Digital Citizenship Privacy & Security Relationships & Communication Social & Emotional Learning

Help kids practice smart internet habits and stay safe online.

Educators' approach to internet safety in the classroom has changed as technology and our use of it continues to evolve. In the past, digital citizenship lessons on internet safety focused more on dos and don'ts, like do create safe passwords and don't talk to strangers online. While secure passwords are certainly important for technology users of all ages, and stranger danger is nothing to take lightly, most internet safety challenges are much more nuanced.

The best internet safety lessons recognize the complexity of these topics and help students build the critical-thinking skills and habits of mind to navigate the dilemmas they encounter. Below are the best internet safety lesson plans for students in grades K–12. See the full Common Sense K–12 Digital Citizenship Curriculum for lesson plans on additional digital citizenship topics.

Kindergarten Internet Safety Lesson Plans

How do you go places safely online? The power of the internet allows students to experience and visit places they might not be able to see in person. But, just like when traveling in the real world, it's important to be safe when traveling online. On this virtual field trip, kids can practice staying safe on online adventures.

First Grade Internet Safety Lesson Plans

How can we be safe, responsible, and respectful online? From our head down to our toes, and our feet up to our nose, the Digital Citizens teach students how to be safe, responsible, and respectful online.  

How do you stay safe when visiting a website or an app? Staying safe online is a lot like staying safe in the real world. Using a fun traffic light activity, students learn how to identify "just right" content, giving them the green light to learn, play, and explore the internet safely.

Second Grade Internet Safety Lesson Plans

What kinds of information should I keep to myself when I use the internet? Staying safe online is a lot like staying safe in the real world. By helping a Digital Citizen sign up for a new app, students learn about the kinds of information they should keep to themselves when they use the internet -- just as they would with a stranger in person.

How are we all part of an online community? We are all connected on the internet! By learning the Rings of Responsibility, students explore how the internet connects us to people in our community and throughout the world. Help your students think critically about the different ways they connect with others, both in person and online.

Third Grade Internet Safety Lesson Plans

How can a strong password help protect your privacy? Stronger, more secure online passwords are a good idea for everyone. But how can we help kids create better passwords and actually remember them? Use the tips in this lesson to help kids make passwords that are both secure and memorable.  

What makes a strong online community? Belonging to various communities is important for kids' development. But some online communities can be healthier than others. Show your students how they can strengthen both online and in-person communities by creating norms that everyone pledges to uphold.

Fourth Grade Internet Safety Lesson Plans

What information about you is OK to share online? It's in our students' nature to share and connect with others. But sharing online comes with some risks. How can we help kids build strong, positive, and safe relationships online? Help your students learn the difference between what's OK to share and what's best left private.

How can I be positive and have fun while playing online games, and help others do the same? Social interaction is part of what makes online gaming so popular and engaging for kids. Of course, online communication can come with some risks. Show your students how to keep their gaming experiences fun, healthy, and positive.

Fifth Grade Internet Safety Lesson Plans

What is clickbait, and how can you avoid it? The internet is full of catchy headlines and outrageous images, all to make us curious and get our attention. But kids don't usually realize: What you click on isn't always what you get. Show your students the best ways to avoid clickbait online.

How do you keep online friendships safe? Kids make friends everywhere they go -- including online. But are all these friendships the same? How can kids start online friendships and learn ways to stay safe? Help your students understand both the benefits and the risks of online-only friendships.

Sixth Grade Internet Safety Lesson Plans

How can you protect yourself from phishing? Internet scams are part of being online today, but many kids might not be aware of them. How do we help our students avoid being tricked into clicking malicious links or giving out private information? Use this lesson to help kids avoid online identity theft and phishing schemes.

How do you chat safely with people you meet online? Games, social media, and other online spaces give kids opportunities to meet and chat with others outside the confines of their real-life communities. But how well do kids actually know the people they're meeting and interacting with? Help students consider whom they're talking to and the types of information they're sharing online.

Seventh Grade Internet Safety Lesson Plans

How do companies collect and use data about you? Every time we go online, we're giving away information about ourselves. But just how much data are companies collecting from us? Hint: It's probably a lot more than we realize. Show your students these three tips on how to limit the data that companies collect.

How does social media affect our relationships? For most middle schoolers, being on social media can mean connecting with friends, sharing pictures, and keeping up to date. But it can also mean big-time distractions, social pressures, and more. Help students navigate the different feelings they may already be experiencing on social media.

Eighth Grade Internet Safety Lesson Plans

How can you protect your privacy when you're online? Kids share a lot of information whenever they go online -- sometimes on purpose, sometimes not. But do they understand that online privacy isn't just what they say and post? Help your students learn about their digital footprints and the steps they can take to shape what others find and see about them.

What are the risks and potential consequences of sexting? It's natural for teens to be curious about their emerging sexuality. But most middle schoolers aren't prepared for the risks of exploring this in the digital age. Help students think critically about self-disclosure in relationships and practice how they'd respond to a situation where sexting -- or a request for sexting -- might happen.

Ninth Grade Internet Safety Lessons

What are the benefits and drawbacks of online tracking? Many of us are aware that we're being tracked when we go online. It's one of the ways our favorite websites and apps know how to recommend content just for us. But how much information are companies actually collecting? And what are they doing with it? Digging into the details can help us make smart decisions about our online privacy and how to protect it.

How can you tell when an online relationship is risky? Getting to know someone online, without nonverbal cues or being able to see them, can be risky -- from simple misunderstandings to manipulation. Help students navigate and avoid these situations before they go too far.

Tenth Grade Internet Safety Lessons

What privacy risks do new technologies present, and how do we decide if they're worth it? New tech, like location services and smart devices, helps make our lives easier and opens opportunities that didn't exist before. But these innovations also come with a cost -- especially to our privacy. Help students consider the benefits and drawbacks of these new technologies -- and decide whether they're ultimately worth it.

How can I make sure my relationships are positive and healthy? "It's complicated" can describe many of our relationships with others, both romantic and otherwise. Add digital devices and social media to the mix, and things get complicated even further. Help students take the first step toward building healthy and rewarding friendships and romantic relationships, both online and off.

Eleventh Grade Internet Safety Lessons

At what age should people be allowed to use social media? Kids have to be at least 13 to sign up for most social media platforms. But we know that many tweens work around the restriction. In doing so they can connect with peers and have fun, but they're also vulnerable to a number of risks -- mainly overuse and challenges to their social-emotional health. Reflecting on age-appropriate content and behaviors can help students think through social media's effects on all of us, regardless of our age.

Twelfth Grade Internet Safety Lessons

Should the government have access to all your social media and cellphone data? Often, the more information we have, the better decisions we're able to make. The power of data can benefit both individuals and governments. But who can be trusted with the responsibility of having all this data? Can governments collect and use it fairly and without violating our privacy? Help students think through this question and become thoughtful influencers of data policy and practice.

Erin’s work focused on supporting students, teachers, and families for over a decade. As content director for family and community engagement at Common Sense, she provided parents and caregivers with practical tips and strategies for managing media and tech at home, and supports teachers in strengthening partnerships with families. Prior to her work with Common Sense, Erin taught public high school students and adult English learners in Kansas City. Her time as a National Writing Project teacher consultant nurtured her passion for student digital creation and media literacy. She has bachelor's degrees in English and secondary education and a master's degree in instructional design and technology. Erin loves to knit, read, hike, and bake. But who has time for hobbies with two young kids? In her free time these days, you'll find her hanging out at playgrounds, the zoo, and the beach with her family.

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Safe Internet Usage

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An official website of the United States government, Department of Justice.

Here's how you know

Official websites use .gov A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS A lock ( Lock A locked padlock ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Internet Safety

Online safety for youth.

This page contains topical federal and federally-supported materials and websites.

Featured Resource

Safety Pledge Developed with funding support from the Office of Juvenile Justice and Delinquency Prevention, the National Center for Missing and Exploited Children (NCMEC) Safety Pledge website provides free resources to help parents, educators, and caregivers learn more about the risks that children face online and how to respond safely. NCMEC partnered with the White House and Department of Justice on this new campaign to combat online child exploitation.

Publications

Keeping Children Safe Online U.S. Computer Emergency Readiness Team, January 2023

Profiles of Youth In-Person and Online Sexual Harassment Victimization National Institute of Justice-Sponsored, July 2021

Adolescents' Exposure to Online Risks: Gender Disparities and Vulnerabilities Related to Online Behaviors National Institute of Justice-Sponsored, May 2021

Staying Safe on Social Network Sites U.S. Computer Emergency Readiness Team, February 2021

Related Resources

Crimes Against Children Research Center Funded in part by the Office of Juvenile Justice and Delinquency Prevention, the Crimes Against Children Research Center serves to combat crimes against children by providing research and statistics to the public, policy makers, law enforcement, and other child welfare personnel.

Federal Bureau of Investigation (FBI) The FBI works to prevent criminals, sexual predators, and others intent on malicious destruction from using the internet and online services to steal from, defraud, and otherwise victimize citizens, businesses, and communities. See the following FBI webpages to learn more:

• Cyber Crime
• Safe Online Surfing
• Violent Crimes Against Children/Online Predators

Federal Trade Commission (FTC): Protecting Kids Online This section of the FTC site provides online privacy guidelines and resources for kids, parents, and educators.

Internet Crimes Against Children (ICAC) Task Force Program Funded by the Office of Juvenile Justice and Delinquency Prevention, the ICAC Task Force Program was created to help law enforcement agencies enhance their investigative response to individuals who use the internet, online communication systems, or other computer technology to sexually exploit children.

Keeping Children Safe Online Due to COVID-19, kids and adults are online more than ever, often unsupervised in the same space. This Department of Justice webpage provides information, tips, videos, and more to help kids stay safe.

National Center for Missing and Exploited Children (NCMEC) The NCMEC mission is to help prevent child abduction and sexual exploitation; help find missing children; and assist victims of child abduction and sexual exploitation, their families, and the professionals who serve them.

NetSmartz Developed in part through funding from the Office of Juvenile Justice and Delinquency Prevention, NetSmartz offers free, multimedia internet safety presentations tailored for specific audiences – parents and communities, tweens, teens, and younger children.

Office of Juvenile Justice and Delinquency Prevention (OJJDP) OJJDP provides national leadership, coordination, and resources to prevent and respond to juvenile delinquency and victimization. See OJJDP's  Sexual Exploitation of Children  page for topical information.

Project iGuardian Project iGuardian is a national cyber safety campaign spearheaded by U.S. Immigration and Customs Enforcement's Homeland Security Investigations in partnership with the National Center for Missing & Exploited Children. As part of Project iGuardian, schools and youth groups can request presentations on how to avoid falling victim to online sexual predators.

Project Safe Childhood (PSC) This U.S. Department of Justice initiative combats the use of computers for the purposes of sexual exploitation crimes against children. It aims to investigate and prosecute offenders, as well as protect and assist victimized children.

U.S. Department of Justice Child Exploitation and Obscenity Section (CEOS) The mission of the CEOS is to protect the welfare of America's children and communities by enforcing federal criminal statutes relating to the exploitation of children and obscenity.

Steven Swensen , High School Principal

“Scott Driscoll’s training on Internet safety and social media is an absolute 'must-have' training for adolescents and parents in today’s society."

Wendy Sander , Connecticut Association of Foster and Adoptive Parents

“Scott is a fantastic presenter for any audience... He uses actual cases to alert students to the dangers of posting on social media, and students quickly realize it could happen to them, too."

Tiffany Violette , High School Principal

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To all my teachers out there as your school year starts please take a break and come join my band as we celebrate and appreciate YOU. This will be a fun evening of music, food/drinks, and celebrating all you do for our children. I hope to see you there. ... See More See Less

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Now is the time to book your school, community, company, or corporation 2024/25 presentations. Contact me with any questions. Be Safe! ... See More See Less

I am thrilled to announce the launch of my new company, New England Educational Solutions! Please visit: www.newenglandeducationalsolutions.com or my facebook page, www.facebook.com/profile.php?id=61555691861006 At New England Educational Solutions, I am dedicated to Unlocking Potential, Inspiring Growth. Through this company, I will offer a wide range of educational programs and seminars tailored for schools, families, communities, and companies taught by myself and experts in their fields. Whether you're looking to enhance your educational offerings, support family safety, or bring inspiring seminars to your community or workplace, I have the solutions you need! Join me on this journey to inspire and empower learners of all ages. Stay tuned for more updates and exciting announcements! #NewEnglandEducationalSolutions #UnlockingPotential #InspiringGrowth #EducationalPrograms #CommunityLearning #FamilyEducation #CorporateSeminars ... See More See Less

New England Educational Solutions, LLC

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Congratulations!

Good luck Scott!

Good morning. Anytime we update our devices, we must understand any changes or new features. The current Apple update included a feature, that when enabled, allows someone to place their phone next to your or your family member's phone, and receive contact information including phone number, email address, picture, and more. To turn this feature off take these steps: 1. Go to Settings 2. Go to General 3. Go to AirDrop 4. Turn Off “Bringing Devices Together” The action of sharing a person's contacts would have to be approved but this feature is up and running after the update. Be Safe! Scott ... See More See Less

• Comments: 6

6 Comments Comment on Facebook

Is it automatic? Or do users need to accept or consent to that? I imagine it would be similar to air drop…

Thanks Scott!!!

Was an honor, as always, to be interviewed by Shawnte Passmore about an online investigation. I hope this segment, along with others Shawnte and I have collaborated on help families be safe. Thanks Shawnte and I look forward to working together again. Be safe! ... See More See Less

It’s been an amazing school year! I just wanted to say thank you to all the schools, towns, youth and family services, and organizations that brought me in for my presentations during the 2022-23 school year. I am honored to say that I conducted 171 presentations during this school year for new and returning clients. I am very grateful for these opportunities to work together to empower students and families. I am looking forward to some opportunities over the summer that will include working with new organizations. I will also be preparing material for next school year, which will include incorporating fresh and, as always, the latest trends in technology. If your school or organization would like information on hosting a presentation, please let me know. Thank you and be safe! ... See More See Less

Could be another tool in our parent “tool box” to help our kids. Be safe! ... See More See Less

TikTok sets new default time limits for minors

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• Press Releases

EMD Serono Unveils New MAVENCLAD® Four-Year Data Highlighting Benefits of Early Treatment and Sustained Efficacy Across Multiple Measures of Disease Activity

EMD Serono today announced presentations showcasing the long-term safety profile, sustained efficacy data, and durable effect of MAVENCLAD® (cladribine) tablets in individuals with RMS.

• Phase IV studies demonstrate the consistent safety and high efficacy of MAVENCLAD on NEDA-3, MRI and cognition outcomes over four years
• New data on blood and CSF biomarkers show the impact of MAVENCLAD to promote immune cell reconstitution, while clinical data confirmed 93.7% of patients free from PIRA
• MAVENCLAD has now treated more than 100,000 patients globally, underscoring its trusted efficacy and safety profile

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced presentations showcasing the long-term safety profile, sustained efficacy data, and durable effect of MAVENCLAD ® (cladribine) tablets in individuals with relapsing multiple sclerosis (RMS). Among 34 total MAVENCLAD presentations are data from several MAGNIFY-MS sub-studies demonstrating the impact of MAVENCLAD on disability progression, central inflammation, and an oral presentation on immune reconstitution effects. These data, along with six other company abstracts, will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place September 18-20 in Copenhagen. 

“The efficacy of MAVENCLAD has long been established through traditional endpoints from our original pivotal trials and beyond. Now, with additional measures of the impact on neuroinflammation and progression, we can reaffirm and further solidify its long-term efficacy position within the MS treatment landscape,” said Alexander Kulla, Senior Vice President & Medical Unit Head Neurology & Immunology at Merck KGaA, Darmstadt, Germany. “MAVENCLAD continues to demonstrate its consistent safety profile with sustained benefits, impacting the lives of more than 100,000 people living with MS."

Results from the MAGNIFY-MS extension, a Phase IV study evaluating patients (n=219) on MAVENCLAD with highly active RMS, confirmed 79.2% of patients achieved no evidence of disease activity (NEDA-3) during Year 4 of the treatment. The annualized relapse rate (ARR) remained low overall (0.09) and was further reduced (0.06) in treatment-naïve patients over four years. Similarly, the CLARIFY-MS extension showed the sustained benefits in MAVENCLAD-treated patients (n=280) on cognition, in addition to MRI outcomes and relapses, four years after the initial treatment dose. Specific to cognition, 77.5% of patients had improved or stable scores at four years, based on the 8-point cut-off of the Symbol Digit Modalities Test (SDMT). In both studies, safety data aligned with the established profile from clinical trials.

Two-year data from a MAGNIFY-MS sub-study found patients with highly active RMS treated with MAVENCLAD had low overall disability accrual, including low rates of progression independent of relapse activity (PIRA). At two years, rates for all disability measures were low overall with 93.7% of patients free from PIRA. The reduction of PIRA is especially notable in treatment-naïve patients (3.4% vs 8.5% in treatment-experienced patients), emphasizing the benefits of early treatment initiation with MAVENCLAD. Overall, these data suggest that MAVENCLAD is likely to preserve the physical abilities and prevent relapses in individuals with RMS, supporting the sustained efficacy and durable effect of MAVENCLAD.

Building on prior data, which showed MAVENCLAD reduces or eliminates oligoclonal bands in the cerebrospinal fluid (CSF), new two-year data demonstrate reductions in gene expression and protein levels of markers associated with inflammation, including pro-inflammatory cytokines, providing insights into the potential multifaceted effect of MAVENCLAD in the peripheral blood and CSF. This data suggests that immune reconstitution following treatment with cladribine tablets may shift the immune system to a less pathogenic state. Analyses of CSF proteomics and T and B cell transcriptomics further substantiate the clinical findings, suggesting the potential of MAVENCLAD to reduce disease activity and progression in RMS patients.

To view our 40 accepted abstracts and posters to be presented from across our MS portfolio at ECTRIMS, including innovative analyses of MAVENCLAD using artificial intelligence, please visit the  Programme .

About MAVENCLAD ® MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception, and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery.

Because cladribine is cytotoxic, special handling and disposal instructions should be followed.

More than 100,000 patients have been treated with MAVENCLAD since its launch in 2019. MAVENCLAD has been approved in over 80 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications. Visit www.MAVENCLAD.com for more information.

IMPORTANT SAFETY INFORMATION

WARNING: MALIGNANCIES and RISK OF TERATOGENICITY

• Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD.
• MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course. Stop MAVENCLAD if the patient becomes pregnant.

CONTRAINDICATIONS

• Patients with current malignancy.
• Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during and for 6 months after the last dose in each treatment course. May cause fetal harm.
• Patients infected with human immunodeficiency virus (HIV).
• Patients with active chronic infections (e.g., hepatitis or tuberculosis).
• Patients with a history of hypersensitivity to cladribine.
• Women intending to breastfeed on a MAVENCLAD treatment day and for 10 days after the last dose.

WARNINGS AND PRECAUTIONS

• Malignancies:  Treatment with MAVENCLAD may increase the risk of malignancy. After the completion of 2 treatment courses, do not administer additional MAVENCLAD treatment during the next 2 years. In clinical studies, patients who received additional MAVENCLAD treatment within 2 years after the first 2 treatment courses had an increased incidence of malignancy. The risk of malignancy with reinitiating MAVENCLAD more than 2 years after the completion of 2 treatment courses has not been studied. Follow standard cancer screening guidelines in patients treated with MAVENCLAD.
• Risk of Teratogenicity:  MAVENCLAD may cause fetal harm when administered to pregnant women. In females of reproductive potential, exclude pregnancy before initiation of each treatment course of MAVENCLAD and prevent by the use of effective contraception during MAVENCLAD dosing and for at least 6 months after the last dose of each treatment course. Women who become pregnant during treatment with MAVENCLAD should discontinue treatment.
• Screen patients for active and latent infections (tuberculosis, hepatitis B or C). Delay treatment until infection is fully resolved or controlled.
• Vaccinate patients who are seronegative for varicella zoster virus (VZV) prior to treatment. Vaccinate patients who are seropositive to VZV with recombinant, adjuvanted zoster vaccine either prior to or during treatment, including when their lymphocyte counts are less than or equal to 500 cells per microliter.
• Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter. Monitor for infections.
• Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with parenteral cladribine for oncologic indications. No case of PML has been reported in clinical studies of cladribine in patients with MS.  Obtain a baseline magnetic resonance imaging (MRI) within 3 months before initiating the first treatment course of MAVENCLAD. At the first sign of PML, withhold MAVENCLAD and perform an evaluation.
• Administer all immunizations (except as noted for VZV) according to immunization guidelines prior to starting MAVENCLAD. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting MAVENCLAD due to risk of infection.
• Infections:  Serious, including life-threatening or fatal, infections have occurred. MAVENCLAD reduces the body's immune defense, and an increased risk of infections has been observed in patients receiving MAVENCLAD. Infections occurred in 49% of MAVENCLAD-treated patients compared to 44% of patients treated with placebo in clinical studies; serious or severe infections occurred in 2.4% of MAVENCLAD- treated patients and 2.0% of placebo-treated patients. The most frequent serious infections included herpes zoster and pyelonephritis. Fungal infections were observed, including cases of coccidioidomycosis. Single fatal cases of tuberculosis and fulminant hepatitis B were reported in the clinical program.
• Hematologic Toxicity:  In addition to lymphopenia, decreases in other blood cells and hematological parameters have been reported with MAVENCLAD in clinical studies. Obtain complete blood count (CBC) with differential including lymphocyte count before and during treatment, periodically thereafter, and when clinically indicated.
• Graft-versus-Host Disease with Blood Transfusions:  Transfusion-associated graft-versus-host disease has been observed rarely after transfusion of nonirradiated blood in patients treated with cladribine for non-MS treatment indications. In patients who require blood transfusion, irradiation of cellular blood components is recommended.
• Liver Injury:  In clinical studies, 0.3% of MAVENCLAD-treated patients had liver injury (serious or causing treatment discontinuation) compared to 0 placebo patients. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment. Discontinue MAVENCLAD if clinically significant liver injury is suspected.
• Hypersensitivity:   If a hypersensitivity reaction is suspected, discontinue MAVENCLAD therapy. Do not use MAVENCLAD in patients with a history of hypersensitivity to cladribine.
• Cardiac Failure:  In clinical studies, one MAVENCLAD-treated patient experienced life-threatening acute cardiac failure with myocarditis, which improved after approximately one week. Cases of cardiac failure have also been reported with parenteral cladribine used for treatment indications other than multiple sclerosis. Instruct patients to seek medical advice if they experience symptoms of cardiac failure (e.g., shortness of breath, rapid or irregular heartbeat, swelling).

Adverse Reactions:  The most common adverse reactions (incidence of >20%) are upper respiratory tract infection, headache, and lymphopenia.

Drug Interactions:  Concomitant use of with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered. Monitor for additive effects on the hematological provide with use of hemotoxic drugs. Avoid concomitant use of antiviral and antiretroviral drugs.  Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.

Use in Specific Populations:  Studies have not been performed in pediatric, or elderly patients >65 years, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.

To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono, Inc. at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.9 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

EMD Serono, Inc. and Multiple Sclerosis For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science. 

About EMD Serono, Inc. EMD Serono - the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada -aspires to create, improve and prolong life for people living with difficult-to-treat conditions like infertility, multiple sclerosis and cancer. The business is imagining the future of healthcare by working to translate the discovery of molecules into potentially meaningful outcomes for people with serious unmet medical needs. EMD Serono’s global roots go back more than 350 years with Merck KGaA, Darmstadt, Germany. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations in Massachusetts.  www.emdserono.com .

About Merck KGaA, Darmstadt, Germany  Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2023, Merck KGaA, Darmstadt, Germany, generated sales of €21 billion in 65 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.