Biosimilar from Development to Registration 2017

Biosimilar from Development to Registration 2017
Event on 2017-08-03 09:00:00
Course "Biosimilar from Development to Registration" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes:
• Design and TPP
• Pre-clinical testing and comparability
• Clinical testing
• Analytical studies
• Stability of biosimilar products

Why you should attend:

The regulation of Biosimilars is very complex and the approach used by various regions differs. Professionals working in this complex area should be equipped with the latest knowledge and keep abreast of current and new legislation and requirements in this field in order to gain market access for their products.

Areas Covered in the Session:

his course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes:
• Design and TPP
• Pre-clinical testing and comparability
• Clinical testing
• Analytical studies
• Stability of biosimilar products

Who Will Benefit:

• Regulatory Affairs
• Medical Officers
• Clinical Trial Managers

Agenda:

Day 1 Schedule

Lecture 1:
Biosimilars challenges and choices
• Definitions
• Risks and benefits
• Historical development
• Regulatory landscape

Lecture 2:
Biosimilars legislation in the EU and the US
• EU legislation
• US legislations

Lecture 3:
Establishing your TPP
TPP for your Biosimilar
Pre-clinical aspects
Comparability and characterization
Pre-clinical testing

Lecture 4:
Important guidelines
Quality
Stability
Pre-clinical testing

CASE STUDY 1 – Including a walkthrough of expected outcomes for all case study exercises
Wrap up of day 1 & Q&A's

Day 2 Schedule

Lecture 1:
Clinical aspects
Phase I
Phase III

Lecture 2:
Important guidelines
Clinical testing
Safety

Lecture 3:
Registration process EMA
Walk through the EU Centralized registration process
What to look out for
Project management

Lecture 4:
Market access for Biosimilars
HTA in Europe/US
CASE STUDY 2 � Including a walkthrough of expected outcomes for all case study exercises
Wrap up of day 2 & Q&A's

Speaker
Salma Michor
PhD, MSc, MBA, CMgr, RAC

Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

Location: Raleigh, NC Date: August 3rd & 4th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until June 20, Early Bird Price: ,295.00 From June 21 to August 01, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901078SEMINAR?eventful-August-2017-SEO
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at Courtyard Raleigh-Durham Airport
2001 Hospitality Ct, Morrisville, NC 27560, United States
Raleigh, United States

Digital Marketing Training – Be Sure You Are Doing It Right!

Digital Marketing Training – Be Sure You Are Doing It Right!
Event on 2017-06-03 10:00:00
Learn the right digital marketing skills needed to grow your business/brand. Enjoy over 80% discount off training fee and also discover all the secrets and everything you need to know about digital marketing.

Imagine if just 10% of 300,000 people buy your product or service at a profit of just 1000Naira? And don't think it is impossible because the population of lagos alone is over 20million! So lets assume only 2% of the total population is online which we is way more than that – Are any of these people aware of your business or service?

Calculating the maths selling a product at a profit of 1000Naira to just 10% of 300,000 people which is less than 2% of the estimated population of Lagos alone can make you over 30Million Naira richer!

But how can you achieve this? Digital marketing is no doubt one of the fastest growing industry in the world right now! And as time goes on, people will continue to use the Internet in even more ways that will impact your business/brand

Below are some modules to be covered:

*Digital Marketing Fundamentals – Getting started: First Things First
*Digital Marketing Industry Statistics & Research
*Creating Personas & Unique Selling Propositions
*Research & How To Find Your Online Audience
*Understanding The Digital Marketing Umbrella & Trifecta
*Creating Your Digital Media Asset & Basic Web Development
*Digital Media Audit & Analysis, Strategy & Planning
*Web Analytics
*Search Engine Optimization & Marketing
*Google Adwords, PPC, CPC & Digital Display Advertising
*Digital Marketing Tools
*Guide To Running Campaigns To Get Higher ROIs
*Identifying The Globally Recognized Certifications & Partners
*Guide On Choosing The Right Digital Marketing Path
*Audience segmentation & retargeting
*How To Get Top 3 Globally Recognized Certifications To Boost Your Credibility & Incease Industry Relevance
*Introduction To Programmatic Advertising & Real Time Bidding
*Introduction To Digital Media Buying & Planning
*Digital Marketing Glossary

At The End Of The Training Participants Also Get:

*168Hrs/30 Days Of After-Training Support
*Certificates Will Be Issued To All Participants
*Letter of Recommendation for Internship (signed by the Webkraft Academy Mgt)
*100+ E-Commerce Layouts (Fashion, Electronics, Food, Furniture & More)
*50+ Premium WordPress Themes
*150,000 E-mail Addresses Of Online Shoppers (Worth N200,000)
*Over 100,000 Phone Numbers (Worth N200,000)
*Premium Industry Reports & Templates
*Exclusive Social Media Industry Reports
*Discounts Off Next Training Programs
*Premium Access To Online Training Resources For Free
*Digital Media Property Audit & Analysis (Worth N150,000)
*Reporting Templates & Other Business Documentations

VENUE: 32B Ologun Agbaje Street Off Adeola Odeku – Victoria Island, Lagos
DATE: Saturday, June – 3rd, 2017
TIME: 10AM – 4PM
FEE: ₦20,000 ( Over 70% Discount off the standard price of ₦85,000! You Save ₦65,000!)

DON'T MISS THIS AMAZING OFFER!​

More details about training available on http://academy.webkraftng.com/

For Inquiries, Please Call 08175446717 or send an e-mail to academy@webkraftng.com

at Webkraft, LLC
32b Ologun Agbaje Street Off Adeola Odeku Victoria Island
Lagos, Nigeria

Website Optimization Course – Rank High in Google – Alameda

Website Optimization Course – Rank High in Google – Alameda
Event on 2016-09-24 09:00:00
Click here to learn more.   How to Optimize Your Website.   So you are found when customers search for products or services that you offer. • It’s one task to create and design your website, it is a completely opposite responsibility to make sure that you optimize your website. • Optimization is using search engine optimization techniques to make sure that your website is appearing in search engine results. • We ultimately show you how to rank in search engine results which supports increasing your conversion rate organically, and sync with your paid advertising efforts.  • Learn overall techniques to optimize your website by watching a LIVE DEMO. • You will be able to implement the tools as you learn. Saturdays: Time:  12:00 Noon EST (9:00 am PST/10:00am MT/11:00am CST) Click here if you prefer Bootcamp or other online marketing courses. All course options: Website Design – September 17 Website Optimization – September 24 Low Cost Internet Advertising – October 1 Branding & Maximizing Your Online Presence – October 8 OR TAKE ALL 4 DURING OUR SMALL BUSINESS BOOTCAMP starting 9/17/16 for only 0.  0 Rebate given during class.  It's like you are attending for almost free. Or take 2 courses for only .99 TAKE ACTION BUSINESS OWNERS!!!  Don't delay – limited seating! Credits:Web Design Words” by KROMKRATHOG. zarlun freedigitalnet retrieved 072116

at Alameda Point
2310 SOUTH SHORES CTR
Alameda, United States

SEO Masterclass and Networking Morning

SEO Masterclass and Networking Morning
Event on 2016-05-26 09:00:00
Get up to speed with the fast-paced world of search engine optimisation (SEO) with this Masterclass from Mediaworks.  Get tips from the industry experts working on some of the largest SEO campaigns in the UK. Learn how to align your site with SEO best practice so you can climb the Google SERP's and attract more traffic.  Don't miss out! Mediaworks is one of the leading online marketing agencies in the UK. We are a young, vibrant, dedicated, client-focused business. We specialise in organic search engine optimisation that drives leads, sales and brand visibility for our clients, but we are also experts in pay-per-click, online reputation management, conversion rate optimisation and content marketing.

at Regus
9-10 St Andrew Square
Edinburgh, United Kingdom

BestAssas.com: Uproar as site ranks sexy Paris students

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The site featured photos of female students, taken without their permission, and allowed users to rank them on how sexy they were and even leave comments beneath the photos. The site called Bestassas.com was named after the University Paris 2 …
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Traffic, crime, unemployment rate, access to restaurants and bars, average rent, and ethnic makeup of the city contributed to Dunwoody's high ranking, according to the website. Dunwoody received an “A” for commute and Niche.com reports those ages 25-34 …
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HBSE 10th & 12th Result 2015 1st & 2nd Sem Result Out: Check Here

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Woman The Powerhouse Global Conference 2015

Woman The Powerhouse Global Conference 2015
Event on 2015-09-18 19:00:00

2014 event was classed as a 5* by delegates and we have raised the BAR for 2015. 

The conference is set to attract more people from the local and international community. 

All our speakers are women of worth, purpose and experience. They are Powerhouses in their own right and we are privilege to have them on board this journey.

Who is this event for?

Woman The Powerhouse has been set up to empower women to do, have and become more through personal and professional development organised events. Our core foundation is EDUCATION followed by motivation. All our organised events are to bring value to the delegates who attend our event. Our global event is to create GLOBAL VISIBILITY platform for those who are looking to expand their network. So, if you are looking to learn from other incredible women are an authority in their field of purpose, this event is for you.

Why is it important to attend?

When women gather they produce greater results through learning, sharing and trading. This increases their net worth of contacts. As a global organisation, our aim is to enrich women by providing platforms for growth and expansion. We have women coming from different continents of the world just to participate at this event. Each one of us has a vital role to play in the development of our net worth through quality network. The global Powerhouse gathering is one not to be missed.

Topics:

  • Global Visibility
  • Leadership development
  • Manifestation
  • Change agent
  • Global economy
  • Net worth
  • Mumprenures
  • Branding
  • Selective service
  • Personal Development
  • Social Media
  • Marketing

Date: Friday, 18th September 2015 ( 6.30pm – 9.30pm) – Gala Night and serious business networking over three course dinner

Saturday, 19th September 2015 (9 am – 5pm) – Main conference

There will be two parts for this event;

1. Gala Night (Friday)

2. Main Conference (Saturday)

We have all the sessions covered…..

An experience of a life time!

Meet the Powerhouse Speakers

Kiran Singh is an Award Winning Mumpreneur, born and brought up in Norway, now based in London for the last 6.5 years with her lively 10.5 year old daughter. An Residential & Hospitality Interior Designer by profession and the proud owner of STUDIO KIRAN SINGH. Got her background in Interior Design, Graphic Design, Web Design, Public Relations & Marketing and Social Media.

She is also the founder and Editor-in-Chief of Vivacious MumMy Unique Home and Passion for Food. Kiran runs a local support group for single parents through Gingerbread.  She is also an Expert at The Women's Room,  HerSay Expert and Interior Expert at Just Do Property.  

 

 Justina Mutale has been acclaimed as one of the most influential and inspirational African women, and in 2012 was awarded the prestigious title of ‘African Woman of the Year’. Justina is Founder/CEO of POSITIVE RUNWAY: The Global Catwalk to Stop the Spread of AIDS. As one of 365 Africa’s most respected names she is Ambassador for Gender Equality & Spokesperson for the International Women’s Think Tank; and is featured in the BLACK 100+ Hall of Fame, an Exhibition and Legacy of the top 100 Black Achievers in modern Britain. She is also listed on the Black Women in Europe PowerList.   Justina has addressed the U.S. National Congress of Black Women in Los Angeles and spoken at the House of Lords and the House of Commons in the UK Houses of Parliament. http://www.justinamutale.com

SOPHIA VAN ROOYEN DHLAMINI

Sophia loves God as her first love.  She is a minister’s daughter.  The eldest of 9 children, 7 brothers and 1 sister.  She grew up in a preacher’s home and saw God working in great wonders with her very own eyes from childhood.  She is passionate about people and loves to serve whenever and wherever possible.

She has travelled different parts of the world while ministering with Youth With A Mission in Hong Kong as a Short Term Missionary.  Sophia worked for a National Airline for 9 years and was the proud owner of African Flavour Tours & Events for a number of years.She currently works as the National Administrator of Assemblies of God Association South Africa.  She is the blessed mother of teenage daughters Hannah-Joy who now serves with Youth With A Mission and Faith Esther who is in Grade 11.  She has been a Single Parent for 9 years.  

·        Sophia graduated with a Bachelor’s Degree in Bible and Theology from Cape Theological Seminary and has been speaking nationally and internationally ministering God’s Word. She is a Credentialed and Ordained Minister with Assemblies of God Southern Africa & Currently CEO/Founder of “Palace Style Coaching and Mentoring” (Non Profit Organisation)

 

Angie Heiman, owner and creator of Celebrate Life LLC. Angie is a Certified Empowerment Coach, Author, Speaker, Teacher and Mastermind Facilitator as well as designer of CREATE, a 6 step process to achieving the life you dream of!

Angie’s practice is based on biblical principles and applied to everyday life. Many women are overworked, underpaid and stressed out before their day even starts. With simple principles Angie shares, her clients have been able to take back control of their lives and tap into their inner Diva to discover a life they once dreamt about.

http://www.celebratelifellc.com

 

Ime Kalu is our appointed Powerhouse representative in the region. She is the CEO of Gorgeous Links Services based in Port Harcourt, Rivers State, Nigeria.

Mrs Kalu is also the President of HELP FOUNDATION, a charity organisation which focuses on supporting the less privilege in our society. Find out more by visiting http://gorgeouslinks.com

 

Catrice Jackson  is the Global Visionary Leader of the GetNAKED Movement with an international mission of setting women and their voices free from all the things that keep the voice of their soul captive. She is also the Founder of theAwakened Conscious Shift and the co-founder of PINK Elephant Conversations; truth-telling talks that are birthing The New Business Paradigm Shift for Creating, Leading, and Cultivating Inclusive, Feminine Communities through Awareness, Radical Acceptance and Authenticity. The Awakened Conscious Shift provides women entrepreneurs with an evolutionary, awakened, conscious, way of living, working, collaborating and creating inclusive, feminine communities that help all women THRIVE!  http://www.catriceology.com

 

Tanya Warner is our USA National Director and she is at the helm of Woman The Powerhouse Global Network. Tanya is the President of renraW Realty Group based in Houston, Texas, USA. She is the best in the market when it comes to Real Estate Consulting. For all your property buying and selling need in the USA (especially in Houston), she is the right person for you. To find out more about her work and how she can support you with your property needs, please visit  https://www.facebook.com/RenrawRealtyGroup?fref=ts

 

Karen passionately believes every woman should be financially independent and after qualifying as a NLP Masters Coach and Hypnotherapist,  Karen has gradually been moving towards the setting up of The Money Goddess Academy, her dream is for women to have access to the knowledge and tools to support them as they work towards becoming financially independent.
http://www.themoneygoddessacademy.com

 

Amaka Kia is an advocate for positive change. She set off as the Business Development Manager and Senior correspondent at Leadership Newspaper in Nigeria. With this appointment, Amaka saw the opportunities that abound in the media and the platform to pursue her dream of empowering other women.

She currently works at  African Independent Television (AIT) as a host to one of the best watched programmes (Our Ladies our Pride).

Our ladies our Pride has in the past three years of its birth brought a new perspective and insight to the role and potentials of women in Nation and family building. The theme song for our Ladies our Pride, ‘Strength of a woman’ by Shaggy, typifies amongst other things her message to every daughter, sister, niece, wife, mother and grandmother. She has helped teach a lot of women how to be independent while upholding their virtues. 
https://www.facebook.com/OurLadiesOurPride?fref=ts

Dawniel Patterson Winningham is Vice President of a fortune 10 firm, 5 time published author, 3 time Presidential Award Winner for community service (2012,2013 Obama, 2005 Bush), Master Life and Business Coach with an International client roster and International Motivational Speaker and Trainer. She is the founder of a national women’s organization named wealthy sisters network (wealthysistersnetwork.org) she is the divorced mother of 3 teens who resides in Houston TX USA. www.iamdawnielwinningham.com.  You can also follow her on Facebook.com/dawnielwinningham or on twitter, Instagram or pinterest @wealthspeaker

 

Rhonda Townsend is an entrepreneurial juggernaut. As a minority female business owner, she's never let societal norms or other people's limitations hold her back. In fact, she excels at making her dreams a reality by designing practical, business savvy processes and carefully implementing each step toward success. Her secret lies in a rare ability to blend her executive managerial skills with creative vision and inspiration. Her motto, “Be you. Live you. Love you,” exemplifies her spirit of enthusiasm, ambition, and respect for individuality.

Educated at The University of Houston and The University of Phoenix, Rhonda draws from her experience serving at high profile companies including Exxon, Hewlett-Packard, and Insperity, to propel her own brand and effectively motivate and manage her team. 
http://www.colournailbar.com/

 

Sponsors from across the globe are welcome.

Ambassadors are welcome too.

Please visit www.womanthepowerhouse.com or email: womanthepowerhouse@gmail.com

at Hilton London Croydon
101 Waddon Way
Croydon, United Kingdom

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