How to Qualify to Participate in FDA's Secure Supply Chain Pilot Program

U.S. FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs.

Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.

It is believed that by creating incentives for manufacturers to adopt best practices for supply chain integrity, FDA can enhance the quality and safety of imported drugs. The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.

During these next two years, the FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.

The 13 prequalified companies accepted into the program that will receive expedited entry, are the following:

1. AbbVie Inc. 
2. Allergan, Inc.
3. Astellas U.S. Technologies, Inc.
4. Bristol-Myers Squibb Company
5. Celgene Corporation 
6. GE Healthcare Inc.
7. GlaxoSmithKline LLC
8. Merck Sharp & Dohme Corporation 
9. Mylan Pharmaceuticals Inc.
10. Novartis Pharmaceuticals Corporation 
11. Pfizer, Inc.
12. Teva Pharmaceutcials USA, Inc.
13. Watson Laboratories, Inc.

What were the Conditions that the above companies met to qualify to participate in FDA's Secure Supply Chain Pilot Program ?

• Commitment  to comply with requirements of the Food, Drug, and Cosmetics Act (FDCA)
• Have a validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism (C-TPAT) program
• Have a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products
• Have an effective recall and corrective action plans in place
• Maintain control over their drugs from the time of manufacture abroad through entry into the United States

Source : FDA

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Compliance Update : FDA and European Medicines Agency strengthen collaboration in Pharmacovigilance area

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

The FDA and the EMA have already set-up such clusters to discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children, blood-based products, among other topics. Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency are also involved in some of these clusters.

As part of the new cluster, discussions on shared pharmacovigilance issues will now take place between the agencies on a monthly basis by teleconference. This increased degree of interaction will allow the agencies to work swiftly in the area of the safety of medicines and to coordinate communication activities. The creation of this cluster is the latest step in the FDA’s and the EMA’s broader approach to expand and reinforce international collaboration.

This type of collaborative effort is important for ensuring the safety and quality of medicines distributed to consumers throughout the globe. The new cluster will help medicines’ regulators harmonize efforts to keep medicines safe, regardless of location.

Canadian and Japanese regulatory authorities will participate in the meetings of the cluster on pharmacovigilance as observers. The information exchange is covered by confidentiality arrangements between the FDA and the other participants.

Source : FDA

For more updates and trainings on FDA Compliance, logon to Compliance Trainings

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FDA’s 21 CFR Part 11 Add-on Inspections

Scheduled On : Thursday, February 27, 2014 at 1 PM EST | 10 AM PST

Duration : 120 Minutes

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Description : 

In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections.

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.

In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. This webinar will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Areas Covered in the Session :

• What is FDA's most current thinking related to computers and electronic records?
• What are the inspection trends?
• What are most frequent recent citations for Part11?
• What are the most frequent deviations for computer system validation?
• Under which circumstances can inspectors exercise enforcement discretion?
• How important is risk based Part11 compliance?
• What is the best strategy for future proven Part 11 compliance?

Who Will Benefit: 

• Quality Managers
• Quality Engineers
• Small business owners
• GxP
• Regulatory Affairs professionals
• Consultants
• Quality VPs
• IT VPs
• Regulatory VP
• CEOs

Speaker Profile

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life science industry

Due-diligence and Gap Analysis in Decision Making Process for Medical Companies

Scheduled On : Wednesday, February 26, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

In this seminar, we will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house from a successful case study.  If it is decided to transfer production what are the options and next steps to transferring it to the right facility or contract manufacturer (CMO).

With the economy, many medical OEMs are deciding whether to invest in upgrading equipment, technology, new personnel, transfer it to a lower cost in-house facility or transfer it to a contract manufacturer.  In many cases this could save the OEM from investing in costly bricks and mortar, new technology and higher labor cost. It also frees up cash and floor space for new product initiatives. This webinar will give you the steps to follow in making decisions that could save money, time and people.  We will explore the importance of quality, cost and on time delivery/flexibility in making the right decisions.

CMO’s have to be ready for a seamless transfer of production by understanding their responsibility and the requirements for a medical device transfer, including the transfer process, validations and the pitfalls that could lead to delays.

Areas Covered in the Session :

• Gap Analysis, Due-diligence and Decision Making 
• Choosing A Contract Manufacturer
• Request for Information (RFI), Request for Proposal (RFP), Request for Quote (RFQ)
• Supplier Audits
• Final Selection & Contract Negotiation
• Project Management
• Supply Chain/Inventory
• Master Validation Plan
• Protocols/Validations
• Transfer Process to an in-house facility or Contract Manufacturer
• Benefits
• Pitfalls
• Post Review/Lessons Learned

Who Will Benefit: 

This webinar will provide valuable assistance and give a procedure to the medical device industry that is thinking of transferring production to a Contract Manufacturer or transferring it to another facility. The personnel who will benefit include:

• Medical Device OEM’s
• OEM and Contract Manufacturing (CMO) Senior Management
• Decision Makers in regulated industries
• R&D and Product Development Engineers and Managers
• Business Development
• Pilot Plant Manager
• Operations Managers
• Plant and Production Managers
• Project and Process Engineers
• Supply Chain Managers
• Global Contract Manufacturing Transfer Teams
• Global Strategic Managers
• Quality and Validation Teams
• Quality and Corporate Auditors
• Contract Manufacturers
• Decision Makers in regulated industries
• Business Development
• Contract Manufacturers
• Plant and Production Managers
• Operation Managers
• Engineering and Contract Manufacturing Transfer Teams
• Project Management Teams
• Project and Process Engineers
• Quality and Validation Teams

Speaker Profile

Robert Braido has 40 years of experience in the medical industry. He is president of Visionary Consulting LLC and has been consulting with medical OEM’s and CMOs for over 7 years. Mr. Braido’s has a broad breadth of medical industry experience in prototype/product development, global strategic/tactical planning, technical due-diligence/gap analysis for acquisitions, engineering, operations and business development. He has had great success working at Ethicon Endo-Surgery a J&J Company, Baxter Healthcare, Teleflex Medical, GW Plastics and The Tech Group with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the Society of Plastic Engineers Medical Division for over 10 years and elected Chairman of the Medical Division twice.

Mr. Braido was selected as a member of a Johnson & Johnson Integration Team that took a small fledgling endoscopic medical device company with totally new products, technologies and structure from $75 million to $850 million in 5 years. His career is built on the ability to motivate, lead and coach people in different disciplines throughout the medical industry. The key factor has been driving innovation.

Mr. Braido was elected, as the Consortium Chairman for the Government Reinvestment Program with MIT, the National Science Foundation and seven leading Fortune 200 companies to commercialize 3D Printing and emerging technologies in plastics and metal. He represented J&J as the principal investigator in the development of 3D Printing with the consortium. He has also been an independent reviewer for the National Science Foundation, J&J, MIT, EdgeOne Medical and others.

He has published numerous technical and leadership articles and white papers. In the past he has shared his extensive experiences at seminars, workshops, technical conferences, symposiums and webinars on subjects relating to the medical and plastics industries on due-diligence/gap analysis, product development, plastic and metal manufacturing, plastic product and equipment transfers, compliance, leadership and developing an innovation culture.

Key Regulatory Documents: DHF, DMR, DHR and Technical File (TF) & Design Dossier

Scheduled On : Wednesday, February 26, 2014 at 1 PM EST | 10 AM PST

Duration : 90 Minutes

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Description : 

There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market.  And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design History File (DHF).  In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical File or Design Dossier.  Currently they serve different purposes, support different goals, but there are some similarities.  And both are moving together in some important areas.  Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both.

What are DMRs and DHRs relationship to DHFs, TF/DDs?

This 90 minute webinar will examine the existing and proposed requirements for the U.S. FDA's DHF and the EU MDD's TF/DD. This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. It also addresses current requirements as well as some changes on the horizon.

Areas Covered in the Session :

• How to meet and document their differing requirements.
• Required and desirable contents.
• Areas requiring frequent re-evaluation / update.
• Similarities and differences, and future convergences and trends.
• Typical DHF contents.
• Typical Technical File or Design Dossier contents.
• The importance and usefulness of the "Essential Requirements".
• Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed.
• Parallel approaches to development.
• Where the Device Master Record / Device History Record "tie in".
• Differing approaches to records audits by the U.S. FDA and an EU Notified Body.

Who Will Benefit: 

This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. Its principles apply to personnel / companies in the Medical Devices,  Diagnostic, and to a lesser extent the Pharmaceutical and Biologics fields. The employees who will benefit include:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operations
• Consultants
• cGMP instructors
• All personnel especially involved in device development, regulatory compliance and documentation. 

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

FDA Electronic Regulatory Filings Submission – Drug Establishment Registrations and Drug Listings

Scheduled On : Tuesday, February 25, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

FDA gives a number of reasons for the decision to move away from paper submissions. These include: electronic review of drug labels for compliance, elimination of data entry errors, and creation of a more efficient and effective process. If you keep in mind that the Gateway can be accessed 24 hours a day, there is the added benefit that properly-created SPL files can theoretically be processed in minutes.

To facilitate the submission of drug establishment registration and drug listing information (including labeling), FDA adopted the use of Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. SPL is based on the Health Level Seven (HL7) version 3 Reference Information Model (RIM) and the Clinical Document Architecture (CDA). Additionally, code sets and codes are used to assist with processing, reviewing, and archiving electronic submissions. The necessary submissions to remain compliant include an Establishment Registration SPL, an NDC Labeler Code Request SPL and a Drug Listing SPL. Once the SPL file is created, it can then be submitted (uploaded) to the ESG. This includes digital certification since the submission is a secure one.

Even with the stated benefits, the electronic submissions process is arduous.  SPL creation is but one hurdle to overcome. FDA actually encourages owners and operators subject to registration and listing to establish accounts (granting access to the ESG) 4-6 weeks in advance of the time to register, list, or update a registration or listing. Having knowledge of the electronic process will best ensure you’re your submissions are not delayed!

US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment registrations, drug listings, annual renewals, and updates. The electronic process replaces FDA paper forms 2656 (Registration of Drug Establishment/Labeler Code Assignment), 2657 (Drug Product Listing), and 2658 (Registered Establishments’ Report of Private Label Distributors). To transmit files, companies must use the FDA’s Electronic Submission Gateway (ESG). According to FDA, moving from a paper-based format to an electronic system has improved the timeliness and accuracy of submissions.

This webinar will provide clarification and guidance on the process of submitting drug establishment registration and drug listing information to the FDA.

Areas Covered in the Session :

• Overview of FDA drug establishment and listing requirement
• Transition from paper-based to electronic process
• Creation of electronic files
• Extensible Markup Language (XML)
• Structured Product Labeling (SPL)
• Codes and code sets
• Establishing FDA Gateway (ESG) account
• Submission to ESG
• Checking drug establishment registration and listing status

Who Will Benefit: 

• Regulatory Affairs professionals
• Project Managers
• QA & QC Managers
• Prescription Drug manufacturers
• Over-the-counter (OTC) Drug manufacturers
• Active pharmaceutical ingredient (API) Drug manufacturers
• Homeopathic Drug manufacturers
• Medical Gas Drug manufacturers
• Consultants
• Any individuals interested in the drug industry

Speaker Profile

Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level.

Ms. Thornton's areas of expertise include regulatory filings, the FDA Electronic Submissions Gateway (ESG), and liaising with government agencies. Also known as the “Perpetual Inquisitive Geek”, she regularly reviews applicable guidance documents, notifications, newsletters, blog postings, and email alerts from various government agencies to stay up-to-date with current requirements and industry trends. Ms. Thornton is a regulatory affairs professional and trainer with a true passion for sharing knowledge effectively.

Avoid Workplace Litigation and Non-Compliance Fines: Conduct an HR Audit

Scheduled On : Thursday, February 20, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

It only takes one disgruntled employee to file a complaint of unfair labor practices to incite a full blown investigation by the IRS, DOL, EEOC, ect. These investigations can interrupt you business as well as be time-consuming and very expensive. Are you prepared? By conducting your own HR Audit, you may avoid litigation and non-compliance fines. An HR Audit can also provide an objective look at the company’s human resources policies, practices, procedures, programs, and strategies to help not only protect the company from litigation and fines; it can establish best practices, identify opportunities for improvement, and evaluate outsourcing options. HR Audits can ensure effective utilization of HR resources and improve customer service, which in turn can increase revenue.

HR Audits can help the company become more efficient as well as save money, reduce productivity time, and cut costs. HR Audits can also help companies avoid non-compliance fees and government audits/intervention, such as Wage and Hour, EEOC, Unemployment, Workers Compensation, Immigration Services, Lawyers, etc.

Areas Covered in the Session :

• What is an HR Audit
• When to Conduct an HR Audit
• Who should conduct the HR Audit
• How to Conduct an HR Audit
• Step-by-Step Sample Audit of Healthcare Company, Including Report Out and Action Plan

Who Will Benefit: 

This is a must attend training for everybody involved in HR Auditing, including: 

• Business Owners
• HR Managers
• HR Representatives
• HR Generalists
• HR Assistants
• Consultants
• Managers
• Supervisors

Speaker Profile

Vanessa G. Nelson, MSA, SPHR, CLRL is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain legal compliance, avoid workplace litigation, reduce costs, increase revenue and competitiveness.

Vanessa established Expert Human Resources in 2009, after observing companies' frustrations with complying with constantly changing employment laws as well as continually dealing with workplace litigations and fines. Vanessa realized that a lot of the litigious situations that businesses encountered could be avoided by their being proactive and implementing updated polices and applying them correctly. Vanessa also recognized that many companies could not afford a full-time HR person, or department, to assist in maintaining compliance with employment laws, as well as applying policies and practices correctly; therefore she established a "portable HR" to accommodate those businesses.

Vanessa is a results-oriented HR Consultant with a unique background in business management, spanning over 29 years at Hurley Medical Center and Sparrow Health Systems. Her expertise includes: HR audits, labor relations, employment laws, employee relations, workplace investigations, and policies and procedures. Additionally, Ms. Nelson has implemented processes to improve conflict management and employee relations; conducted harassment training to improve company efficiencies, worked with multiple unions to produce positive outcomes, and has recruited dozens of talented employees. She is mobile and able to quickly interpret and apply policies fairly and consistently.

Ms. Nelson received her Master of Science in Administration/Human Resources Management from Central Michigan University, and a Bachelor in Business Management from Northwood University. She holds the Certified Senior Professional in Human Resources (SPHR) credential from Human Resources Certification Institute, Certified Labor Relations Leader (CLRL) from Michigan State University, and is Six Sigma White Belt certified.

Vanessa has conducted multiple seminars including: Lawsuits Waiting to Happen, Human Resources and Employment Law Updates, How to Conduct Effective Investigations, and FMLA.

Cyber Security Planning for Medical Devices

Scheduled On : Thursday, February 20, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures can lead to a risk to health that prompts other regulatory requirements, such as Medical Device Reports, Reports of Corrections and Removals and potentially to premarket requirements where the redesign of cyber security software results in a significant change to a device. There is an open question about whether any correction of software should be reported to the FDA. The webinar will integrate these issues so you can understand the need for cyber security and develop a comprehensive plan to manage the real possibility of a fatal hack attack.

Cyber Security issues address software vulnerabilities. Exploiting software vulnerabilities, such as with “hacking,” can lead to devastating results. In terms of medical devices, malicious hacking can lead to serious injury or death. When FDA began to regulate medical devices, software had not evolved to a level of pervasive use, as a stand alone device or as a customized platform for institutional use. Even today, FDA struggles to keep up with the evolution of software, its applications and its inherent risks. There are many instances of how cyber security measures are inadequate for commercial and personal use software. What happens when the software malfunctions or fails to perform is a necessary consideration now. For example, someone in a remote location can cause a life sustaining device to stop working. That ability has been proven. The elements of design, operation and correction of corrupted software require rigorous evaluation. As health care technology and cost management increasingly rely on software, the potential for an increased incidence of adverse events related to hacking will follow.

Areas Covered in the Session :

• FDA Draft Guidance entitled, “Content of Premarket Submissions for Management of Cyber Security in Medical Devices.” 
• FDA Safety Alert entitled, “Cyber Security for Medical Devices and Hospital Networks: FDA Safety Communication
• Device regulatory requirements before and after marketing 
• Risk to health consequences of  Cyber Security failure
• Off-the-Shelf software Cyber Security

Who Will Benefit: 

• Software specification developers and engineers
• Information technology managers
• Regulatory affairs senior managers
• Risk managers for clinical institutions
• Clinical management teams
• Patient managers for life supporting/life sustaining devices
• Crisis intervention planners
• Customer training managers
• Manufacturers with a history of software recalls
• Devices Manufacturers that use software
• FDA device consultants
• Third party software designers / engineers
• Clinical institutions
• Entire staff of a start up device manufacturing firms

Speaker Profile

Casper Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program. He is “of counsel” at Olsson Frank Weeda (OFWLAW) in Washington, DC and licensed to practice in Massachusetts and the District of Columbia.

Compliance Update : How does FDA Evaluate The Regulated Drugs ?

The Food and Drug Administration’s Strategic Action Plan for Risk Communication is an initiative to tell consumers how the agency makes decisions on the safety and effectiveness of FDA-regulated products. This is the first in a series of articles about the data and methods—and their limitations—that FDA uses to determine whether products are safe for patients and consumers to use.

This is how the agency’s Center for Drug Evaluation and Research evaluates the safety and effectiveness of drugs.

The Regulation of Drugs
How the Facts Are Collected

• The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works and if it will be safe enough to be tested in humans. The company submits an Investigational New Drug Application (IND) for FDA’s review prior to testing in humans.
• The company performs a series of clinical trials in humans in three phases, which FDA monitors, to test if the drug is effective and safe.
• Next, the company sends its data from all these tests to FDA's Center for Drug Evaluation and Research (CDER) in a New Drug Application (NDA). A team of CDER physicians, statisticians, toxicologists, pharmacologists, chemists and other scientists review the data and proposed labeling.
• If this review establishes that a drug's benefits outweigh its known risks for its proposed use, the drug is approved for sale.
• After the drug is on the market, the FDA monitors its performance in a number of ways. One of those ways is the through MedWatch, the agency’s safety information and adverse event reporting program, which receives reports of suspected adverse reactions (side effects of medicines) from consumers, health care practitioners and pharmaceutical companies. And the agency has access to databases that collect information on prescription drug use and health outcomes. These data help FDA staff identify and understand side effects of medicines.
• If an unexpected drug-related health risk is detected, a Drug Safety Communication may be issued to consumers and healthcare professionals. A statement is added to the drug label about the new safety concern to ensure continued safe and effective use of the drug. Occasionally, approved drugs may be withdrawn from the market for serious safety risks if it is determined that the overall risks outweigh any benefits the drug may provide.

The Limitations of Safety Data

• FDA provides guidance to companies during the various phases of the human clinical trials. Even so, the number of people in a clinical trial of a new drug is usually small in comparison to the number of people who may take the drug if it reaches the market. This makes it difficult to detect rare side effects.
• Even though data from human trials are analyzed by a team of experts before a drug is approved, it can be impossible to anticipate all bad reactions—especially very rare safety risks—unless they had also happened with use of a similar drug.
• Complicating matters is the fact that after they are approved, drugs are often taken by sick people who are on other medications at the same time, making it difficult to predict how they will react to the drug. And the drug’s effect on the patient may change over the course of years.
• There are hundreds of thousands of adverse events reported via MedWatch each year, but this reporting system is voluntary and there are serious drug reactions that are never reported.
• Because the nation’s healthcare system is not integrated, there is no standard way to track the adverse effects of a medicine in any given health system or across different health systems. Health insurance databases can be helpful in this regard, but they are only accurate as long as a patient has the same job and is enrolled with the same insurance system since many people are insured through their employer. This limits FDA’s ability to monitor the safety of medications taken over many years.  However, FDA, through its Sentinel Initiative, is currently working to develop capabilities to use data from different health systems to better understand the safety of drugs in clinical practice.

Ultimately, FDA faces a balancing act in evaluating a new drug. If it’s good for one person or a small group, will it be good for the whole population?  Which safety risks are likely to be acceptable to patients who might take a drug and physicians who might prescribe it? Once a drug is marketed and new information about its safety becomes available, FDA must revisit these questions continually over the drug’s lifecycle.

In the end, no matter how much data are available, we often have to make a judgment call, weighing the known benefits against known risks and the potential—and possibly unknown—risks.

Source: FDA
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Improved Generic Drugs via the 505(b)(2) Regulatory Pathway: FDA Approval Made Easy

Scheduled On : Wednesday, February 19, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3 years of market exclusivity available to the approved product.

Despite being around for more than 25 years, same as generic drugs, the 505(b)(2) products have only recently become more popular. The main reason is that due to several similarities with generic products, 505(b)(2) products offer some unique challenges. Just like NDAs for new drugs, 505(b)(2) products are subject to full user fee under the Prescription Drug User Fee Act (PDUFA), could require several clinical and non-clinical studies and could take a significant allocation of resources, albeit less than that for a brand new product but much higher than that for a generic drug. Like all drug development strategies, 505(b)(2) pathway requires careful consideration and planning taking into account all the potential issues to be addressed before embarking on development.

This pathway is particularly attractive to manufacturers transitioning from generic drugs to innovator products. Due to the similarities with traditional drug development, they offer a low risk market entry point by training the work force in the traditional development processes. However, as would be evident, there are unique challenges to developing such products – scientific, regulatory, logistical and financial – all of which could convert a potentially attractive project into a constant headache.

This seminar will discuss the practical strategies for drug development via 505(b)(2) regulatory pathway. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, market access, reimbursement issues and projected trends for the near future. Lastly, the 505(b)(2) pathway will be compared to that for biosimilars.

At the end of the seminar, the attendees will be familiar with the following: 

• FDA guidance on 505(b)(2) products
• Gap analysis and IND strategy for new formulations of previously FDA-approved drugs
• Meeting with FDA to discuss 505(b)(2) submissions
• Trends in FDA review of INDs and NDAs for 505(b)(2) products 
• Do’s and Don’ts for development plans for 505(b)(2) products

Areas Covered in the Session :

• The 505(B)(2) regulation and guidance from the FDA
• Strategic considerations before embarking on a 505(b)(2) development project
• Intellectual property issues with such products
• Key development steps for such products
• FDA’s review process and ongoing consultation
• Challenges to developing 505(b)(2) product and possible solutions
• Examples of successful strategies for developing such products
• Searching for a 505(b)(2) project, future trends
• 505(b)(2) and biosimilars

Who Will Benefit: 

The following individuals or disciplines will benefit from attending this Webinar: 

• Regulatory affairs professionals
• Senior management executives (CEO, COO, CFO, etc)
• Drug discovery and development professionals (R&D and CMC)
• Intellectual property experts
• Project Managers and Clinical trial specialists
• Regulatory Compliance Associates and Managers
• People investing in FDA-regulated product development projects

Speaker Profile

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

Scheduled On : Wednesday, February 19, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods and complex filing systems for purposes of retrieval and control.  These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry.

As is often the case, automation and computers do not always replace the legacy methods, policies, and rules that were necessary with manual and paper systems but are now obsolete.

Unfortunately, that is the case in the overwhelming majority of medical device companies.  The benefits of automation and information retrieval systems are not fully realized due to the legacy policy constraints that still hamper them.

If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work.

In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven
practices.

Areas Covered in the Session :

• Brief introduction to Lean Documents and Lean Configuration
• Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
• Basic functions found in a life sciences manufacturing plant
• Key types of controlled documents and records for manufacturing
• Quality Management System (QMS) elements controlled via documentation
• Bringing it all together

Who Will Benefit: 

All Managers, Supervisors, Directors, and Vice-Presidents in the areas of: 

• R&D
• Design Assurance
• Quality Assurance
• Operations
• Document Control
• Manufacturing Engineering

Speaker Profile

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Johnson & Johnson company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.