This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market.
We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. This seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and familiarize the attendees with the regulatory landscape in which INDs and NDAs are developed and approved.
Areas Covered in the Session:
- High level overview of the FDA approval process for a new drug
- What is an IND? Identify the key contents of an IND
- What is an NDA? Identify the contents of an NDA
- The FDA IND and NDA review process
- Discovery stage
- Preclinical Testing
- IND Application
- Clinical Trials
- Phases I to IV
- High-level description of medical device process
Who Will Benefit:
- Clinical Trials Associates
- Regulatory Affairs
Fatuga is a social-entrepreneur who is actively engaged in three primary roles/companies: (a) founder/president of Caligeo Clinical OneVision; (b) founder/CEO of Caligeo Clinical CRO; and (c) founder/Executive Director of Atlanta Premier SMO. His professional passion lies in promoting clinical trial opportunities in emerging markets (especially in Africa, the Caribbean, East Asia, and Latin America) and among under-represented population (in the USA). He recently completed his MBA degree from Emory University/Goizueta Business School with a focus on Entrepreneurial ship/Organizational Behavior & Management. He received his M.Sc. in Drug Regulatory Affairs and Health Policies from Massachusetts College of Pharmacy and Health Sciences and BS degree in Neuroscience from Brown University. He has more than 15 years of experience in the clinical research industry. Fatuga began his clinical research career as a study coordinator at Brown University. Since then, he has had leadership opportunities as Clinical Team Manager, Project Lead, QA/QC Manager, Lead CRA, CRA Consultant, Medical Research Associate, and CRA Specialist in a variety of companies such as central imaging facility, Contract Research Organizations (CROs), biotechnology and pharmaceutical companies. Fatuga is currently certified as a Project Management Professional (PMP) and a Clinical Research Associate (CCRA). He is an active member of the International GCP Training Advisory Board for the Association of Good Clinical Practices in Nigeria (AGCPN) and also a member of Nigerian Association of Pharmacist and Pharmaceutical Scientists in the Americas (NAPPSA). Fatuga is also a member of the International Committee/Leadership Team of the National Biotechnology and Pharmaceutical Association (NBPA) which is a US based organization functioning in collaborative efforts to discuss challenges and opportunities of conducting clinical trials with diverse communities as well as addressing the disparity issues in the clinical trial industry.
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In late 2016, Canada introduced new changes to its food labeling regulation, which does away with the existing one, the Guide to Food Labelling and Advertising. Codified under what is called the Industry Labelling Tool; this regulation tool provides guidance to a number of important aspects of food, such as:
- Food Products that Require a Label
- General Principles for Labelling and Advertising
- Labelling Requirements Checklist
Aim of the new food labeling regulation in Canada
The main aim of the new food labeling regulation in Canada is to make it easier for consumers to understand the nutrition information more easily and make informed choices about the food they consume.
It also seeks to bring safer food for the country’s children by making changes into the labels of food meant for children. Towards this, it will continue to implement the recommendations the World Health Organization passed in 2010 to ensure safer food and beverages for children.
At the time of passing the new food labeling regulation in Canada; the WHO guideline was being implemented vigorously in Quebec for children below the age of 13.
How is the new food labeling regulation in Canada being implemented?
The new food labeling regulation in Canada, which was enacted in late 2016, expects the designated industries to implement the guidelines set out in the Industry Labelling Tool over a five-year period. Some of the amendments that come up for the earliest phase of implementation cover the food color specifications and the removal of synthetic color specification. The implementation of these amendments has started in early 2017. Consultations have been going on with food experts, stakeholders, the industry and the general public.
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Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone. we never expected to actually to connect with other people in the blogging community.
we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!
we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.
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Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.
Logistics and supply chain management is emerging as a major area of business because of the evolution and growth of globalization. Many products and goods are produced in one country and consumed in another situated thousands of miles away. The right logistics and supply chain management helps to deliver the goods and products to the right person, at the right time, at the right place and in the right condition. Lack of proper logistics and supply chain management is a recipe for disaster.
What is logistics and supply chain management?Among the lay people, there is a tendency to use the two words synonymously and interchangeably. In trade, however, there are major differences between the two. Logistics is just a part of the supply chain. In simple, general and broad terms, one can understand the difference between logistics and supply chain in the following ways:
Logistics is a part of supply chain, meaning that it is a set of activities that are carried out within an organization. Supply chain, on the other hand, is the full set of activities that are carried out from start to finish, i.e., from the time it departs the organization that it is leaving till the time it reaches its logical destination. In this process, supply chain management involves the coordination and collaboration of many entities. In this sense, supply chain is a whole set of activities, of which logistics is only a part.
Another way of understanding logistics and supply chain management
Another way of understanding logistics and supply chain management is this:
Logistics can be understood as being a discipline in which the following activities are involved:
On the other hand, supply chain management can be said to include more extended activities, which include:
Logistics and its extended activitiesLogistics often is described in terms of inbound and outbound logistics. Simply put, inbound logistics is the movement of raw materials and goods that are bought by and transported into a company. When these are processed and finished and shipped to customers; they become part of outbound logistics.
Logistics and supply chain management in a broader contextWhen one tries to get an understanding of logistics and supply chain management at a higher or broader level in the way logistics has been described above; supply chain management can be understood as consisting of these elements:
A sound supply chain system seeks to create value for the organization by building and utilizing logistics infrastructure. Logistics and supply chain management become meaningful when the organization synergizes demand with supply, stock and supply and inventory management
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