GMP and Regulatory Expectations for Early IND Products 2017

GMP and Regulatory Expectations for Early IND Products 2017
Event on 2017-11-13 09:00:00
Course "GMP and Regulatory Expectations for Early IND Products" 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 present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

Why should you attend:

Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this.

Who will benefit:

• Directors, Managers, Supervisors, and lead workers in Regulatory Affairs, Quality Assurance and Quality Control
• Workers who will prepare GMP documents for early phase products as well as those who will review these documents
• Regulatory affairs workers who will need to deal with submissions covering early phase products

Agenda:
Day 1 Schedule

Lecture 1:
Very Early Stages
• The need for documentation of matters that will affect downstream work.
• The effects of ICH Q8
o Impact on R & D activities
o Risk analysis and design control at this stage.
Lecture 2:
GLP requirements
• Animal studies
o Toxicology and pharmacokinetics.
• Estimating the Maximum Safe Starting Dose
o A review of the guidance document.
Lecture 3:
Early Pre-IND Studies
• Understanding exploratory Studies
o Definitions and the IND that will be withdrawn.
• Orphan Drugs
• Drugs studied under the Animal Rule
o What they are and how to conduct the studies.
Lecture 4:
Meetings and Preparing for the IND
• Information required for the Phase 1 IND
o The CMC requirements that will be needed.
• Pre-IND Meetings with FDA

Day 2 Schedule

Lecture 1:
GMPs for Phase 1 IND products
• The scope of the guidance document
• The second guidance document covering the GMPs.
Lecture 2:
GMPs for Phase 1 continued
• A presentation covering what GMPs are required at this stage.
• What has been omitted from the GMPs for Phase 1.
Lecture 3:
Requirements for Phase 2 INDs
• The full GMPs resume, but do they?
• Phase 2 studies and the transition to full GMPs.
• CMC requirements.
Lecture 4:
Preparing for IND Meetings
• Phase 1 meetings
• Pre-phase 2 meetings
• Phase 2 meetings

Speaker
Dr. Steven Kuwahara
Founder & Principal, GXP Biotechnology, LLC

Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

Location: Taipei, Taiwan Date: November 13th & 14th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON , Taipei, Taiwan
Price:

Price: 5.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: ,685.00 ,475.00 You Save: ,790.00 (40%)*
Register now and save 0. (Early Bird)
Until October 05, Early Bird Price: 5.00 From October 06 to November 11, Regular Price: ,095.00
Register for 10 attendees Price: ,922.00 ,950.00 You Save: ,028.00 (45%)*

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.
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at Taipei, Taiwan
Taipei, Taiwan
, Taiwan

Masterclass – Communicating Effectively as a Business

Masterclass – Communicating Effectively as a Business
Event on 2017-10-26 09:00:00
Effective communications and marketing play a vital role in any organisation’s performance. Keep ahead of the competition and update your skills in this short, interactive workshop providing participants with a taster and introduction to the key themes and actions involved in effective communication. New for 2017 the masterclass will cover; 1. What is communications / marketing and why should you have a strategy and a plan? Introduction to the benefits of planning. 2. How to build an effective brand identity Building the foundations – mission statement and purpose / values / USP / branding and style and the importance of consistency in everything that you do. Key tools to have eg boilerplates, brand folder. 3. How to make sure you stand out from your competitors Looking at your USP, what makes you different to your competitors? What are your competitors doing well or not so well? What are they saying or not saying that you can take advantage of? 4. How to target your audience Who do you need to communicate with and why? Where do they go? What do they do? What are they interested in? 5. How to write an effective plan Make sure what you do is aligned with your business goals and objectives. Be specific and consistent. Prioritising your actions and your budget. How do you know if it works? Reviewing your actions Workshops run by experts Lucy Rennie – Director at Lucy Rennie Communications Limited We are a strategic communications agency that helps your business to shine through excellent communication. With over 15 years’ experience working in international business, communications and marketing, at Lucy Rennie Communications, we understand the different challenges you face and can speak the same language. We are fiercely passionate about people, communications and public relations and our vision is to provide expertise, know-how and enthusiasm to small and medium sized business owners, managers and teams in an approachable, affordable and flexible way. We strongly believe that everything you do should be in line with your business objectives, values and brand identity, so we work with you to define your bespoke communications strategy with them in mind.

at Harborough Innovation Centre
Wellington Way, Airfield Business Park
Hull, United Kingdom

Digital Marketing Training in Temecula,CA-USA|Eduscil

Digital Marketing Training in Temecula,CA-USA|Eduscil
Event on 2018-06-26 09:00:00
Digital Marketing Certified Associate Training The course covers core concepts of Digital Marketing such as Search Engine Optimization (SEO), Social Media Marketing, Pay-Per-Click (PPC), Website Conversion Rate Optimization, Web Analytics, Content Marketing, Mobile Marketing, Email Marketing, and Digital Marketing Strategy. The course will also help you master tools and platforms such as Google Analytics, AdWords, Twitter, YouTube, and Facebook. It includes Mimic Pro simulations to augment the concepts learned via virtual experience. Eduscil is conducting 4 days Digital Marketing Training in all major cities in United States. Register for this 4 day Digital Marketing training (Live Virtual classroom training course-Instructor Led), spread over one weekday and clear the Digital Marketing Exam from an expert trainer.  Features of Digital Marketing Training:  Online Interactive classroom training session spread over one weekends/weekdays Simulated Digital Marketing practice test Answers and explanations for all the practice questions Learn from an Digital Marketing expert Trainer Get 32 Contact Hours PDU certificate Examination fees included 100% Digital Marketing Exam pass back guarantee Case studies in the classroom training session Life time access to Digital Marketing recorded session Global Approvals and Accreditation Convenient classroom and online courses Courses conducted across the globe  For more information about our Digital Marketing training, please e-mail support@eduscil.com or Call Now! On +1 (713) 239 3167 | +1 (713) 239 3241 We also deliver onsite training for corporate groups. Contact us for group/corporate discount. 5.00% for 3-4 people 10.00% for 5-9 people 15.00% for 10 and above people Visit us at Digital Marketing Training to know more about our certification training courses in Program Management, ITIL, IT Service Management, Quality Management, Agile, Scrum, and related fields. We conduct Digital Marketing Training courses in Phoenix, Charlotte, Minneapolis, Boston, Chicago, Houston, Phoenix, Chicago, Washington, Los Angeles, Washington, Indianapolis, Dallas, San Diego, Baltimore and Richmond around USA… Please visit us at http://www.eduscil.com/ to know more about our professional certification training courses in India and across the globe. Please Contact Eduscil Solutions LLC: E-mail: support@eduscil.com or tony@eduscil.com Website: www.eduscil.com Call Us Now!: USA: +1 (713) 239 3167 | +1 (713) 239 3241

at Temecula
31505 Congressional Drive
Temecula, United States

FREE 2H Internet Marketing Workshop: Perth, AU

FREE 2H Internet Marketing Workshop: Perth, AU
Event on 2017-10-17 12:30:00
How To Start Your Online Marketing Business In 2017! Perth, AU October 17, 2017 12:30pm- 2:30pm   Learn Simple, Proven and Exciting Ways To Build A Successful Business Using Online Marketing Strategies   Register Now For Your FREE 2 Hour Workshop…   How would you like to learn how to build a business from scratch using the latest online marketing strategies? The formula for creating a business from scratch and using the internet to sell your products, tools and services. We will show you how to license other products if you don't want to create them yourself. How you can get off the ground quickly by tapping into NEW platforms, where all the products & marketing are done for you. How to flood your business with sales every single day from automated traffic that converts leads into sales while you sleep. How to tie everything together, and walk out the room with a bullet-proof plan to hit your online business goals in 2017. DON'T MISS this event… Events like this have the capability of creating a breakthrough for you… We'll tell you all about this when we meet, but just know this event is mindset shifting… and potentially life-changing…   BUT only if you attend.   Make sure you secure your seat right now and we'll see you there…   ** Choose Your SESSION when you reserve your seat… **   Register Now For Your FREE 2 Hour Workshop…   FAQ:Q: Would it be possible for me to take a long friend(s) or business partner(s)?A: Yes, this is possible. Do make sure that you register the people you will bring with to the Workshop.Q: Do I need any experience in order to understand what is being taught at the Workshop?A: No, we will teach you exactly and step by step how to generate a full time income in your spare time.Q: Does my age, education background matter?A: No, it doesn't. Our oldest student 72 years "young" and definitely not computer savvy.Q: Is this event really free?A: Yes, it is absolutely free to come and learn at this event. Register Now For Your FREE 2 Hour Workshop…

at Novotel Perth Langley
221 Adelaide Terrace
Perth, Australia

Digital Marketing Training in Abilene,TX-USA|Eduscil

Digital Marketing Training in Abilene,TX-USA|Eduscil
Event on 2017-10-24 09:00:00
Digital Marketing Certified Associate Training The course covers core concepts of Digital Marketing such as Search Engine Optimization (SEO), Social Media Marketing, Pay-Per-Click (PPC), Website Conversion Rate Optimization, Web Analytics, Content Marketing, Mobile Marketing, Email Marketing, and Digital Marketing Strategy. The course will also help you master tools and platforms such as Google Analytics, AdWords, Twitter, YouTube, and Facebook. It includes Mimic Pro simulations to augment the concepts learned via virtual experience. Eduscil is conducting 4 days Digital Marketing Training in all major cities in United States. Register for this 4 day Digital Marketing training (Live Virtual classroom training course-Instructor Led), spread over one weekday and clear the Digital Marketing Exam from an expert trainer.  Features of Digital Marketing Training:  Online Interactive classroom training session spread over one weekends/weekdays Simulated Digital Marketing practice test Answers and explanations for all the practice questions Learn from an Digital Marketing expert Trainer Get 32 Contact Hours PDU certificate Examination fees included 100% Digital Marketing Exam pass back guarantee Case studies in the classroom training session Life time access to Digital Marketing recorded session Global Approvals and Accreditation Convenient classroom and online courses Courses conducted across the globe  For more information about our Digital Marketing training, please e-mail support@eduscil.com or Call Now! On +1 (713) 239 3167 | +1 (713) 239 3241 We also deliver onsite training for corporate groups. Contact us for group/corporate discount. 5.00% for 3-4 people 10.00% for 5-9 people 15.00% for 10 and above people Visit us at Digital Marketing Training to know more about our certification training courses in Program Management, ITIL, IT Service Management, Quality Management, Agile, Scrum, and related fields. We conduct Digital Marketing Training courses in Phoenix, Charlotte, Minneapolis, Boston, Chicago, Houston, Phoenix, Chicago, Washington, Los Angeles, Washington, Indianapolis, Dallas, San Diego, Baltimore and Richmond around USA… Please visit us at http://www.eduscil.com/ to know more about our professional certification training courses in India and across the globe. Please Contact Eduscil Solutions LLC: E-mail: support@eduscil.com or tony@eduscil.com Website: www.eduscil.com Call Us Now!: USA: +1 (713) 239 3167 | +1 (713) 239 3241

at Abilene
104 Pine St #304
Abilene, United States

Professional Certificate in Digital Marketing – Ballincollig – 12th Oct

Professional Certificate in Digital Marketing – Ballincollig – 12th Oct
Event on 2017-10-12 18:30:00
Certified Digital Marketing Professional This program provides an in-depth and comprehensive introduction to the core essentials of digital marketing. Validated by the Digital Marketing Institutes Industry Advisory Council, the learning content is informed and designed by experts and offers learners the opportunity to gain a globally recognised professional certification. Covered within this program are the structural foundations of digital marketing, including strategy & planning, search, social media, PPC, email marketing, analytics and much more. The course runs for 10 weeks 12th of October to the 14th of December 2017 (inclusive) Thursday evenings 18:30pm to 21:30pm Course location –  Ballincollig, Cork Final exam takes place in January 2018, allowing study time after course completion Why should I earn this certification? Future-proof your career by gaining the latest and most up-to-date digital marketing skills needed to thrive in today’s ever-evolving digital economy. By becoming a Certified Digital Marketing Professional, you will be prepared to take up a more evolved role in the overall marketing field and ensure you know the tools and skills needed to create a cohesive, effective online strategy. This certification is recommended for a variety of professionals including Marketing Executives, Managers, IT Managers and Senior Management. It is also ideal for small business owners or anyone involved in the planning, implementation or measurement of digital strategies, along with anyone keen to pursue a career in digital marketing. Becoming a Certified Digital Marketing Professional will benefit you regardless of your skills and experience and will empower you to maximize the impact of your marketing through powerful digital tools. What will I accomplish? Upon successful completion of a 3 hour Pearson VUE computer-based examination, candidates will be awarded the world’s most widely recognized digital marketing certification. Certified professionals will gain the confidence needed to create and steer a revenue- generating digital marketing strategy for companies of any size. An internationally recognised certified professional badge will also be available for you to display upon on your LinkedIn profile. There are ten modules in this program: Introduction to Digital Marketing Search Marketing: SEO Search Marketing: PPC Digital Display Advertising (DDA) Email Marketing Social Media Marketing (Part 1) Social Media Marketing (Part 2) Mobile Marketing Analytics Strategy & Planning Module Descriptions: Introduction to Digital Marketing The Introduction to Digital Marketing module explores how to harness the power of digital within the context of your organization’s marketing strategy. You will gain an understanding of the core principles of digital marketing through a foundational introduction to each, be able to distinguish between traditional and digital techniques, whilst also gaining insight into creating, implementing and measuring effective digital marketing campaigns. Search Marketing: SEO This explores the concept of search engine optimization and how you can use key techniques and tools to enhance your website’s organic ranking on search result pages. Key terminology and technical insights are explored as you learn how to cultivate an SEO strategy. Search Marketing: PPC This Search Marketing module demonstrates the importance of Pay-Per-Click advertising in driving quality traffic to a website. You will learn the terminology and technical skills needed to setup a Google AdWords account, conduct keyword research and run an effective PPC campaign. Digital Display Advertising This module dissects how to create and implement effective digital display advertising campaign. It covers the core concepts, terminology and campaign aspects that should be considered whilst establishing, maintaining and optimizing digital display advertising. Email Marketing The Email Marketing module discussed how to construct and deliver an effective email marketing campaign. You will learn how to write engaging email content, split test email design templates and test varying campaign to achieve optimal open and click through rates. Social Media Marketing (Part 1) The first Social Media Marketing module covers the key concepts and terminology used in social media marketing and its primary platforms including Facebook, Instagram, Twitter and LinkedIn. You will learn how to define goals, set KPIs for your social media campaigns, engage with customers effectively and ensure you understand the suitability of different social media platforms for your objectives. Social Media Marketing (Part 2) The second Social Media Marketing module expands upon the topics and platforms introduced in the first. You will understand the challenges involved in implementing an effective social media strategy for your business and explore advanced platforms, such as Facebook Insights and Twitter Analytics which possess scheduling, managing and reporting features. Mobile Marketing This module will enable you to create and deliver effective mobile marketing campaigns. Explored within this module are the key concepts that underpin mobile marketing, the value of immediacy, mobility, personalization and mobile optimization. Analytics The Analytics module will help you develop the knowledge and skillset required to measure, monitor and optimize digital marketing activity. You will gain a technical understanding and insight required to build an online reporting function for your business. Strategy and Planning You will understand how to adopt a structured approach to creating a formal digital marketing plan for your organization or business through this module. It encompasses budgeting, resource allocation and channel selection. 

at New Minds College
Ballincollig
Cork, Ireland

2-Hour FREE Internet Marketing Seminar – GAINESVILLE, FLORIDA

2-Hour FREE Internet Marketing Seminar – GAINESVILLE, FLORIDA
Event on 2017-10-03 12:30:00
How To Start Your Online Marketing Business In 2017 ! Learn Simple and Proven System How To Build A Successful Online Marketing Business Register Now For Your FREE 2-Hour Seminar in Gainesville, Florida How would you like to learn the formula for creating a business from scratch and using the internet to sell your products and services ? How you can get off the ground quickly by tapping into NEW platforms, where all the products and marketing are done for you ? DON'T MISS this event … make sure you secure your seat right now. This upcoming seminar is for you if you are looking at an option starting your digital marketing business part-time or full-time from home, and if you are interested to find out how to utilize licensed products if you don't want to create them yourself. This session is FREE so bring along your friend if you wish. Kindly ask them to reserve a seat too through the same link but with their own email address.  And don't forget to ask for your 3 FREE BONUSES before you leave the room.  If you have any questions, please don't hesitate to reach out to me. Register Now For Your FREE 2-Hour Seminar in Gainesville, Florida

at Holiday Inn University Center
1250 W University Avenue
Gainesville, United States

PRINCE2® Foundation and Practitioner Certification Training Course in Baltimore, MD-USA

PRINCE2® Foundation and Practitioner Certification Training Course in Baltimore, MD-USA
Event on 2017-09-26 09:00:00
iCert Global is conducting 4 days PRINCE2® Foundation and Practitioner Certification Training Course in Baltimore, MD On Sep 26 Through 29, 2017.
Register for this 4-days PRINCE2 Foundation and Practitioner classroom training course, spread over weekdays and prepare for the PRINCE2 examination with training by an expert instructor with hands-on PRINCE2 experience.
We are an AXELOS Certified Partner and an Acquires Accredited Training Organization (ATO) and a People Cert Accredited Training Organization (ATO) for providing PRINCE2 Foundation and Practitioner certification exam training across the globe.
Features of our PRINCE2 Certification Training:
• 4 days of Instructor led training
• Learn from Industry best certified Instructor
• High Quality e-Learning Content with 180 days free access (worth 9)
• Get 32 PDU certificate
• Approved courseware
• Prince2 Foundation and practitioner exam fee included with course fee
• ATO of AQUIROS and PEOPLECERT
For more information about our PRINCE2 Foundation and Practitioner certification training courses, please e-mail info@icertglobal.comor call Adam on +1 (713)-287-1252.
Visit us at PRINCE2® Foundation and Practitioner to know more about our certification training courses in PRINCE2®, CAPM®, PRINCE2® Foundation, PRINCE2® Practitioner, PRINCE2® Foundation & Practitioner, PRINCE2® Agile, CBAP®, MSP, CMMI.
We conduct PRINCE2® Foundation and Practitioner training courses in Washington, Texas, Carolina, Florida, Nebraska, Louisiana, Missouri’s, Connecticut, Michigan, Ohio, Georgia, Oklahoma, Virginia, Dallas, Chicago, Phoenix, Charlotte, Minneapolis, Boston, Phoenix, Chicago, Washington, Los Angeles, Indianapolis around USA.. Please visit us at http://www.icertglobal.com/ to know more about our professional certification training courses in across the globe.
Please Contact iCert Global Learning:
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at La Quinta Inn & Suites Baltimore N / White Marsh
4 Philadelphia Ct, Baltimore, MD 21237, USA
Rosedale, United States