Quality & Equivalence of Topical Products & NaNOTECHNOLOGY CHALLENGES hybrid workshop
On 6 April 2021
EMA’s proposed guideline on quality and equivalence of topical products - future advances and challenges of nanotechnology
Realising the new guideline on EMA Quality and Equivalence of Topical Products will be enacted soon and such guideline will have both immediate as well as long term consequences on the industry, Dr. Hasler-Nguyen thus decided to organise this special workshop by bringing together a panel of four international experts, who will share their research and practical experiences on the challenges and potential benefits of this new guideline. By contrast, nanotechnology, which brings innovation in medicines development has not yet any guideline. Nanotechnology challenges will be addressed too.
Program
On 6 April 2021
Talk title
Affiliation
13:15
Opening access – Workcast
Regulatory position of the EMA/FDA
14:45 Talk & QA
Topical Classification Drug System
Pharmaceutical Consultant, Formerly with US FDA.
15:15 Talk & QA
RiverD (Gerwin Puppels)
Gen2-SCA
Netherlands
15:45 Break
NEW APPROACHES
16:00
Video
Visit Lab Prof Kalia
University Geneva, CH
16:15 Talk & QA
Cutaneous Biodistribution: A New Tool for Formulation Development and the Assessment of Bioequivalence of Topical Dermatological Products
University Geneva, CH
16:45 Talk & QA
BASF (Benjamin Goodyear )
ZoomLab
USA
17:00 Talk & QA
Teledyne Hanson (Bruna Lousada)
Phoenix RDS
USA
17:15 Talk & QA
Delphin Technologies Ltd (Jouni Nuutinen)
VapoMeter
Finland
17:30 Talk & QA
Qualimetrix (Maria Mastrogiannopoulou)
Contract Research Organization
Greece
Nanotechnology Challenges & Opportunities
17:45 Talk & QA
Challenges of New Nanotechnology Medical Products and their Follow-ons
University Basel, CH
18:15 Talk & QA
Opportunities of Nanotechnology for Topical Dermal Medicines
University Geneva, CH
18:45
Panel Discussion
All
19:30
END
SPEAKERs
PROF. YOGESHVAR KALIA
Professor Kalia has worked in biopharmaceutics (speciality: transdermal drug delivery), first at the University of California – San Francisco since 1994 and since 1997 at the University of Geneva.
He has published ~130 papers (h-index 49 (8007 total citations (Harzing’s Publish or Perish, v. 4.29.1.6134); 59 papers as corresponding author), 17 book chapters and presented ~180 communications at national / international conferences and he is a co-inventor on 4 patents. Currently he serves on the Editorial Boards of the European Journal of Pharmaceutics and Biopharmaceutics and Expert Opinion on Drug Delivery; He is also a reviewer for several journals in the fields of pharmaceutical and biomedical sciences.
PROF. RICHARD GUY
Professor Richard Guy received an M.A. in Chemistry from Oxford University, and his Ph.D. in Pharmaceutical Chemistry from the UCL School of Pharmacy. He has held academic posts at the University of California, San Francisco and the University of Geneva. In 2004, he joined the University of Bath as Professor of Pharmaceutical Sciences in the Department of Pharmacy & Pharmacology. Dr. Guy’s research focuses on skin barrier function characterization, transdermal drug delivery, enhancement of percutaneous absorption, iontophoresis, noninvasive biosensing, and the prediction and assessment of skin penetration and topical bioavailability. He has published 380+ peer-reviewed articles and over 70 book chapters. He has co-authored one book, co-edited 7 others, and he is co-inventor of 12 patents. In 2016, he was awarded the degree of Doctor of Science from Oxford University and the Maurice-Marie Janot Award from APGI for original and innovative research in pharmaceutics, biopharmaceutics and pharmaceutical technology. Having received the Founders’ Award of the Controlled Release Society (CRS) in 2013, Dr. Guy was the first recipient of the CRS Transdermal Delivery Kydonieus Foundation Award in 2018.
DR. VINOD SHAH
Dr. Shah is a Pharmaceutical Consultant. He worked at US Food and Drug Administration (FDA) for over 30 years and developed several Regulatory Guidances in the area of dissolution, SUPAC, topical drugs, bioequivalence and biopharmaceutics. He is author/co-author of over 300 scientific papers and is a co-editor of four books.
Dr. Shah is a Fellow of American Association of Pharmaceutical Scientists (AAPS) and of International Pharmaceutical Federation (FIP). He is a recipient of FDA Award of Merit and Distinguished Career Service Award, FIP Lifetime Achievement Award in Pharmaceutical Sciences, Honorary Doctorate from Semmelweis University, Budapest, Hungary, Honorary Doctorate from University of Medicine and Pharmacy Carol Davila Bucharest, Romania, AAPS Distinguished Pharmaceutical Scientist Award and AAPS Global Leader Award
PROF. STEFAN MUHLEBACH
Professor Mühlebach is a trained hospital pharmacist and pharmacologist. He worked for 25 years as head pharmacy in the hospital of Biel/Bienne and Aarau (Switzerland). He got his venia docendi in 1993 in Bern and was promoted professor for pharmacology and hospital pharmacy 2004 at the University of Basel. He worked from 2005-2008 with the National Agency for Therapeutic Products (Swissmedic), was head of the pharmacopoeia and of their delegation at EDQM in Strasbourg. With his role in Industry (Vifor Pharma Ltd from 2009-2019 as a regulatory science lead for Non-Biologcal Complex Drugs (NBCDs) / Nanomedicines) he focused on the regulatory and scientific challenges with these products and their follow-on versions (similars) and their appropriate use also as the chair of the NBCD Working Group at Lygature in the Netherland. Most of his peer-reviewed publications in pharmacology, hospital pharmacy, clinical nutrition, nanomedicines, and regulatory sciences, are cited in PubMed. Based on 230 articles, several books/book chapter (12), Google Scholar indicates a citation number in total (since 2014) of 2967 (2225), an h-index 24 (18) and an i10 index of 35 (31). A total of over 400 oral presentations accumulated over time. Stefan Mühlebach is also a member and Fellow of the Swiss Academia of Pharmaceutical Sciences, serving as Vice-president from 2009-2018. He holds numerous national and international scientic awards and got in 2019 an honorary doctorate from the Pharmacy Faculty of the Semmelweis University for his multiple academic contributions in pharmacy.
Dr. Maria Lapteva
Dr. Maria Lapteva is currently occupying senior scientist in Prof. Kalia’s group. She has over 10 years of experience in preclinical drug development, formulation and delivery together with a strong expertise in surfactant and nanoparticulate formulations. Her interest in topical drug delivery have led her to develop numerous methods to elucidate the drug distribution in various tissues, especially in the skin. She has authored 18 conference communications, 14 peer reviewed publications, 4 book chapters and is listed as co-inventor on 1 patent. She is appointed as reviewer for several journals in the field of pharmaceutics and biomedical sciences and serves as Topic Editor for Pharmaceutics.
PROF. Christian Surber
Christian Surber, Ph.D., is Professor of Dermatopharmacology and Hospital Pharmacy at the University of Basel and visiting Professor at the Departments of Dermatology in Basel and Zürich, Switzerland.
His research interest and expertise are a) the in vivo assessment and optimization of drug delivery from topical formulations, b) topical delivery vehicle design, c) topical bioavailability /bioequivalence testing, d) topical pharmacotherapy of barrier function impairment (dry skin, atopic dermatitis, psoriasis) and solar damage (skin cancer), e) development of sun protective means and f) patient and consumer adherence to topical pharmacotherapy and to topical protection and care products. He has numerous publications, patents, conference presentations and reference texts covering various aspects of dermal drug delivery, topical bioavailability /bioequivalence and topical pharmacotherapy of barrier function impairment and solar damage. He supervises doctoral students and teaches as a lecturer in Dermatology and Pharmacy at the University of Basel and Zürich.
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