Day 1 :
Keynote Forum
Michael Drues
Vascular Sciences, USA
Keynote: Conducting effective FDA pre-sub meetings: Tell don’t ask… lead don’t follow!
Time : 10:50-11:10
Biography:
Abstract:
For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays.
Manufacturers may assume a classification or regulatory pathway for a new device – only to learn later that FDA disagrees.
Unfortunately, most of these delays are completely avoidable! The ‘pre-sub’ program – an expansion of the pre-IDE program– allows manufacturers to request meetings regarding devices currently under development and/or regulatory review. Although CDRH issued guidance on the pre-sub program in 2014, many companies do not use this program effectively, and some don’t use it at all for fear their regulatory burden will be increased rather than reduced. When used effectively, pre-subs can offer significant advantages to the manufacturer by getting their device to market sooner. But if not used properly, pre-subs can add tremendous burden by increasing time to market. This presentation will use the case study approach to present the pre-sub process in an interactive fashion including:
When should the pre-sub program be used and when should it not be? How does the process work and what can the manufacturer expect?
When is it better to meet formally or informally? Should you meet in person or via teleconference?
What info should be provided in advance and what should be provided at the meeting?
What happens after the meeting? How should the manufacturer follow-up? Are the results binding?
Are there other ways to communicate with FDA beyond pre-subs and when should they be used?
In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative ways to use the presub
program to their advantage! For additional information, check out: How to Make the Most of Your Pre-Sub Interactions
with FDA; Communicating With FDA: How (And When) To Get It Right; 3 Tips to Vastly Improve Your FDA Communication Strategy; How to Make the Most of Your Pre-Submission Interactions with FDA How to Properly Use the FDA Pre-Submission Process and Why It's So Important; When and How To Interact With the FDA; FDA Pre-Submission Meetings: Strategies for Medtech Entrepreneurs; Communication With FDA: What Do We Say and How Do We Say It? ; Guerilla Regulatory Strategy
- Good Laboratory Practices | Good Pharmacovigilance Practices| Audits and inspections | Regulatory & Pharmacovigilance|FDA and related regulatory agencies
Location: Zurich
Chair
Eliana Silva de Moraes
ABPVS, Brazil
Co-Chair
Diadelis Remirez Figueredo
Devices and medical equipments (CECMED), Cuba
Session Introduction
Parminder Kaur
RegPak BioPharma Consulting, Netherlands
Title: Medical device vigilance in EU
Time : 13:50-14:10
Biography:
Parminder Kaur is a regulatory expert and a QPPV having 19 years of recognised global expertise in a broad range of therapy areas. She has also played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies; assisted various companies during Inspections and Audits conducted by EU Regulatory Authorities. Parminder was awarded Sikh Business Women of the year award in 2014. In 2011, she led an IMI Project on combination therapy at EFPIA, in close collaboration with Research & Development Group (RDG) at European Commission. In March 2007, Mrs. Kaur had been selected by the European Federation of Pharmaceutical Industries and Association (EFPIA) for her global expertise and also had an honour to be the Scientific Representative from India for the year 2000-2001, duly sponsored by UNESCO. Parminder had also been a speaker, panellist and Masterclass provider at various National and international Conferences. Parminder is currently running her own regulatory affairs and pharmacovigilance consultancy, RegPak BioPharma
Consulting based in Amsterdam
Abstract:
Medical device vigilance is the monitoring of the safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action.This to ensure that patient’s and healthcare professional’s safety is monitored and action taken as soon as a safety concern with a medical device arises. Manufacturers are obliged to maintain robust medical device vigilance and post marketing surveillance systems in order to attain and maintain their CE certificate. This session will focus on requirements for a robust medical device
vigilance system in EU and how to achieve a strong QMS.
R C Jagessar
University of Guyana, Guyana
Title: Antimicrobial activity of the ethanolic and aqueous extract of Vicia faba L. (Fabaceae)
Time : 14:10-14:30
Biography:
R C Jagessar has obtained his BSc in Chemistry/Biology from the University of Guyana in 1992. He has then proceeded on a scholarship to pursue his PhD in the UK which he obtained in 1995. He pursued his Postdoctoral Research in the USA at the University of South Carolina, Wichita State University and later at the University of the West Indies, UWI. His research interests are broad, covering the spectrum of pure and applied chemistry, chemical biology, pharmaceutical and medicinal chemistry. He has won several international awards such as the Chartered Chemist, Chem of the Royal Society of Chemistry, Fellow of the Royal Society of Chemistry, FRSC, Royal Society Chemistry Research Grants etc. He is currently one of the recipients of the World Bank Grant from the University of Guyana Science & Technology Support Project Research Grant (2014-2016), UGSTSP. He has published 65 full peer reviewed papers, inclusive of four book chapters, exclusive of research abstracts, presented at conferences, both locally and internationally and has been a Reviewer of several international journals. He is currently a Lecturer of Chemistry in the Department of Chemistry.
Abstract:
The aqueous and ethanolic extract of Vicia faba L. (Fabaceae) exhibited antimicrobial activity against the pathogenic microorganisms: E. coli, S. aureus, K. pneumoniae and C. albicans. This was evaluated using the Disc Diffusion Assay under aseptic conditions. Antimicrobial activity was not induced by the solvent, ethanol nor water as the diameter zone of inhibition (DZOI) was less than 5 mm. The highest area of zone of inhibition (AZOI) was 153.9 mm2 and the lowest 12.56 mm2. Negligible Zone of Inhibition (ZOI) was observed in several instances. The aqueous extract of the fruit also induced negligible zone of inhibition. In comparison to the reference, Ampicillin and Nystatin, values are less. As the concentration of the metal salt, Zn(OAc)2.2H2O and ethanolic extract increases, there seem to be a variation in antimicrobial activity. Zn(OAc)2.2H2O appears to intensify the antimicrobial activity of Vicia faba L. ethanolic and aqueous extract. Zn(OAc)2.2H2O in the absence of any extracts exhibited antimicrobial activity, the AZOI range from 47.2 mm2 to 117.8 mm2. Antimicrobial selectivity was also observed in several instances, for example, the ethanolic extract induces AZOI of 50 mm2 against C. albicans whereas negligible AZOI was obtained against K. pneumoniae and E. coli.
Michael Drues
Vascular Sciences, USA
Title: The many connotations of risk and the consequences of getting them wrong
Time : 14:30-14:50
Biography:
Michael Drues, is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays Dr. Drues received his B.S., M.S.,. degrees in Biomedical Engineering from Iowa State University. He works with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services and other regulatory and governmental agencies around the world. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and shortcourses
for medical device, pharmaceutical and biotechnology companies, the FDA, Health Canada, the US and European Patent Offices, CMS and other regulatory and governmental agencies around the world. Finally, Dr. Drues is an Adjunct Professor of Regulatory Affairs, Medicine and Biomedical Engineering at several universities and medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs and Product Development, Combination Products and Pathophysiology.
Abstract:
Risk is a topic of importance from both regulatory and quality perspectives. However, despite have systems and standards in place, not dealing with risk appropriately continues to be a frequent cause of problems to the industry. Risk mitigation typically starts with a brainstorming session: the product development team randomly rattles off risks and writes them down.
This “cherry-picking” approach is a haphazard process because whether you spend an hour or a year, you can never be certain you have captured all the important risks. This workshop is not the typical ISO14971, QMS or Design Control approaches which although commonly followed, all take a very limited view of risk and is simply not adequate! During this workshop, a
systematic, engineering-minded approach to risk is presented. Multiple examples of devices are used to demonstrate:
What are the three buckets of risk and how to apply them?
What’s the difference between a risk mitigation strategy and a risk management plan?
How to deemphasize or not draw attention to certain risks?
What’s the relationship between risk mitigation and product liability?
How to handle risks in off-label uses without creating product liability nightmares?
How to factor regulatory risk into the equation?
Ultimately risk is not a simple matter. Manufacturers need to understand the impact of risk mitigation strategy on a regulatory submission as it can make or break a submission, especially a 510(k) or de novo. Your risk management plan is also very important, not just to meet the design control requirements, but in terms of product liability, as well. A successful medical device manufacturer must carefully consider not only what you say regarding risk and how you say it, but also what you don’t say and how you don’t say it! What to know more? See: How to Think Outside the Checkboxes of Risk Management.
Using the Bucket Method for Medical Device Risk Management. Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? Risk Management from a Regulatory & Product Development Perspective. Intersection of Usability and Risk Management (April, 2017). The Many Connotations of Risk and Consequences of Getting Them Wrong. Risk Management for Medical Device Manufacturers
P Brindha
Sastra University, India
Title: Traditional plant drugs as potential immunomodulators
Time : 14:50-15:10
Biography:
Abstract:
Management of various diseases through immunomodulation is the current trend and recent researchers worldwide are focusing their research towards developing immunomodulating plant drugs that act as prophylactic or therapeutic agents. Adverse side effects such as kidney failure, anemic conditions, bone marrow disorders and sudden decrease in platelet counts which are often encountered due to the longer administration of synthetic immunomodulatory agents have forced researchers to take up researches on immunomodulatory drug development. Besides synthetic immunomodulatory agents are costly, hence there is a need for an alternative cost effective human friendly plant based immunomodulatory agents. A review is carried out on traditional Ayurveda and Siddha literature to suggest natural herbal sources that could enhance immune system either as immunostimulator or as immune suppressor and contribute towards the health care of human society. These plant drugs could be used successfully in the management of various immune dysfunctions or in case of residual cancer. Several molecules have also been isolated from these plant sources which stimulate immune responses. In the present paper various immunomodulatory plant sources available in India are discussed and presented.
Rashid Mahmood
Surge Laboratories Private Limited., Pakistan
Title: Cleaning validation in pharmaceuticals
Time : 15:10-15:30
Biography:
Rashid Mahmood has completed Master’s degree in Analytical Chemistry and in Total Quality Management. He has 13 years of experience of Pharmaceutical Quality Operations and has attended many international conferences as a keynote speaker. Currently he is working as a Senior Executive Manager Quality
Operations for Surge Laboratories Pvt. Ltd, Pakistan
Abstract:
In the manufacturing of the pharmaceutical products, it is very necessary to reproduce consistently the desired quality of product. The current Good Manufacturing Practice (cGMP) regulations recognize that cleaning is a critical issue to ensure product quality. The control of cross contamination plays a critical role in maintaining the quality of the product. The manufacturing of API and pharmaceutical products involves series of processing steps and use of various equipments. In many cases, the same equipment may be used for processing different products. Residual materials from the previous batch of the same product or from different product may be carried to the next batch of the product, which in-turn may alter the quality of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product including intermediates and impurities, cleaning agents and extraneous material into subsequent product to a level which is below predetermined level. The documented evidence of the consistent performance of the cleaning process is given by the validation process. It ensures safety, efficacy and quality of the subsequent batches of the drug product. In this article the various aspects of the cleaning validation such as different types
of contaminants, sampling procedures, analytical techniques and regulatory requirements are discussed in detail.
Muhammad Naeem,
Indus Pharma (Pvt.) Ltd, Pakistan
Title: Roadmap to pharmaceutical regulatory harmonization in Pakistan
Time : 15:50-16:10
Biography:
Muhammad Naeem has more than 19 years diversified experience in quality operations, regulatory affairs, research and development. He has done certificate courses on cGMP, GLP, Process Validation, ISO/IEC 17025:2005, 14001:2004, OHSAS 18001:2007, SA 8000 and 9001:2008. He is a Member of International Society for Pharmaceutical Engineering (ISPE) and Regulatory Affairs Professional Society (RAPS), USA. He has extensive knowledge of ICH, USP, BP, ASTM, and HACCP and has led several investigational/developmental and technical/analytical projects at CMOs in USA, Europe and Pakistan. Some of the major pharmaceuticals he served are Pfizer & Takeda (USA), CCL Pharmaceuticals and INDUS Pharma, Pakistan. He has strong scientific, analytical, planning, managerial and training skills.
Abstract:
Introduction: Provision of affordable quality pharmaceuticals is an integral part of every national health policy. Attaining optimal quality standards for pharmaceutical products is impossible without an effective pharmaceutical regulation regime that protects public health by ensuring safe, effective and quality pharmaceuticals and detecting illegal manufacturing and
trade. Pakistan, despite having a large Pharmaceutical sector (over 600 manufacturing units; market size of around 3 billion dollars) has not realized its true potential in the area due to non-adherence to globally accepted quality standards. There is a huge unexploited potential for export of the country's pharmaceutical products especially in the context of the GSP Plus status
granted to Pakistan by the European Union. History & Challenges: In Pakistan, the ministry of health (MoH) used to regulate drug manufacturing and pricing at the federal level. After the decentralization of the Health Ministry (2011), Drug Regulatory Authority of Pakistan (DRAP) came into being (December 2012). DRAP has been continuously evolving and advancing in its vision and procedures; there is still a long way to go in order to overcome its current challenges like premarket evaluation and registration, post-market surveillance, cost recovery, price control, international harmonization, access to regulated markets and capturing the scientific advancements for modernization of act and regulations etc.
Recommendations: Promote harmonization of regulatory processes by adopting globally harmonized standards; establish targeted capacity-building for quality APIs; introduce an online submission system for dossiers/query responses etc., train the regulators; hire more staff and set transparent pricing rules.
Conclusion & Significance: Pharma regulatory authorities all over the world are rapidly advancing. Likewise, DRAP is already on its way for reformation and improvement. The recommendations in this presentation may prove helpful for DRAP in its journey towards excellence.
Parminder Kaur
RegPak BioPharma Consulting, Netherlands
Title: Early access to unapproved medicines in EU
Time : 16:10-16:30
Biography:
Parminder Kaur is a Regulatory Expert and a QPPV having 19 years of recognized global expertise in a broad range of therapy areas. She has also played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies; assisted various companies during inspections and audits conducted by EU Regulatory Authorities. She was awarded Sikh Business Women of the year award in 2014. In 2011, she led an IMI Project on combination therapy at EFPIA, in close collaboration with Research & Development Group (RDG) at European Commission. In March 2007, she was selected by the European Federation of Pharmaceutical Industries and Association (EFPIA) for her global expertise and also had an honor to be the Scientific Representative from India for the year 2000-2001, duly sponsored by UNESCO. She is currently running her own regulatory affairs and pharmacovigilance consultancy, RegPak BioPharma Consulting based in Amsterdam.
Abstract:
Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global
commercialization strategies. This session outlines various circumstances to be considered for the implementation of EAPs named patient programs, EU regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation.
Yavuz S SILAY
ICG (Istanbul Consulting Group), USA
Title: Strategic trends, current and future competitive landscape in biologics and biosimilars (follow-on biologics) drug development in USA and emerging markets-a brief snapshot from 2012 through 2022
Time : 16:30-16:50
Biography:
Dr. Silay serving as the Chairman of Labiopharma, LLC in US, providing clinical trial administration, market access, medical writing, patient recruitment, retention, regulatory and medical affairs support, drug repositioning for hospitals, academic institutions and pharmaceutical companies from preclinical to post marketing stages for several years. Dr. Silay is also providing comprehensive and strategic consulting services for the approval of Drugs and Medical Devices and attended several meetings with FDA, EMA, Health Canada and Turkish Health authorities and social security institute. Dr. Silay in US, most recently worked as the Vice President, Medical Affairs, and head of Medical Affairs Neurology in the US headquarters Basking Ridge, New Jersey reporting to the President and CEO of Ipsen
North America where he was key in building a Neurology Franchise by hiring many employees. He has Proven ability to build high performing teams and productive organizations, turn around brands, and build revenue in diverse markets. As the former director, Market Access & Health Policy for AIFD( Research Based Pharmaceutical Companies) which the 40 members represent all major global pharmaceutical companies, 650 billion dollars of 1 billion dollar Global Pharmaceutical market. He represented pharmaceutical companies and was in discussion with all ministerial levels, including ministry of health, finance, labor, development and science& technology in Turkey.
Abstract:
A presence in biologics and biosimilars has become a strategic priority for nearly all the world’s leading and emerging pharmaceutical companies. Below is an approximate snapshot of biologic drug sales for top 10 pharmaceutical companies during last five years and future five years will be discussed. Biosimilars or follow-on biologics are similar terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. The following topics during this presentation will be briefly discussed; Historical growth of the biologics market, Leading players, Changes to the competitive landscape 2017-2022 and Outlook for the biologics market, Leading players in 2016 vs 2022. Subsequently; Some examples of biosimilars and how it may affect the biologics will be briefly explained. While the FDA designates interchangeability, states control drug substitution laws. Once an interchangeability designation is acquired, a biosimilar may be substituted for the reference product by the pharmacist at the retail or specialty pharmacy without the intervention of the prescriber in states that have approved legislation or regulation establishing state standards for biosimilar substitution. As of January 2017, there are no interchangeable biologics approved in the U S. Biologics generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes, unlike the more common small-molecule drugs. The follow-on manufacturer may not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product. Differences in impurities and/or breakdown products may have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the product. While summarizing above dynamics, the status and most recent developments in biologics and biosimilar (follow-on) drug development in United States of America and global trends will be explained.