| 2024 | | |
| Upcoming… |
| How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE | 1/2 Oct |  | Oberursel | AGAH-Workshop “Applied Course in Clinical Pharmacokinetics” |
| Data Manipulation in Bioequivalence: Recent history and Current Practices in Europe | 13 Jun |  |  virtual | SAAMnow Spring Workshop on Data Integrity in BE Studies |
| Past… |
| HVD and Type I Error | 16 Apr | | Rockville | 6th International Workshop – GBHI 2024 |
| 2023 | | |
| Data Manipulation in Bioequivalence | 29 Nov |  | Brussels
Bruxelles
Brussel | Medicines for Europe’s BE Working Party meeting |
| ICH M13A: testing for multi-group- and multi-center–effects in comparative BA trials: statistical considerations and consequences for interpretation | 11 Oct | | Frankfurt | Experience meets Expertise. BE: New Trends and recent Discussions. |
| How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE | 5/6 Oct | | Oberursel | AGAH-Workshop “Applied Course in Clinical Pharmacokinetics” |
| Sex– and group–related problems in BE. A delusion. | 21/22 Sep |  | Prague
Praha | BioBridges 2023 |
| Statistical challenges and opportunities in ICH M13A | 26 Apr | | Brussels
Bruxelles
Brussel
| Medicines for Europe’s 2nd Bioequivalence Workshop |
| 2022 | | |
| How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE | 6/7 Oct | | Oberursel | AGAH-Workshop “Introduction into Basic Principles of Pharmacokinetics” |
| Novel approaches in adaptive designs and α adjustment, e.g., with futility criteria and for parallel design studies • Discussion | Consumer risk in SABE | 28/29 Sep |  | Amsterdam | 5th International Conference of the Global Bioequivalence Harmonisation Initiative |
| tmax Evaluation – Where are we and where will we go… | 22/23 Sep | | Prague
Praha | BioBridges 2022 |
| 2021 | | |
| Bioequivalence – An Old Area with some Uncharted Territories | 15 Dec |  | Vienna
Wien
virtual | Biometric Colloquium |
| Critical Remarks on Reference-Scaled Average Bioequivalence | 22 Oct |  | Yaroslavl
Яросла́вль
virtual | 3rd International conference «The life cycle of medicines: simple and complex tasks» |
| Steady-State Studies | 29 Apr |  | São Paulo
virtual | Estudos em doses múltiplas para medicamentos genéricos e similares de liberação modificada – Contexto nacional e internacional |
| 2020 | | |
| Steady-state Studies • Pilot Studies • Two-Stage Designs • Replicate Designs • Outliers in Bioequivalence | 11–13 Feb | | Campinas | Network of Scientific Excellence |
| 2019 | | |
| Similarity and Comparability • Validation and Compliance Issues | 4–6 Nov |  | Athens
Αθήνα | Bioequivalence, Dissolution & Biowaivers |
| Critical aspects regarding – not only – statistical analysis of BE studies. Experiences of a consultant | 2 Oct | | Vienna
Wien | European Inspectors’ Meeting |
| General Principles of Biostudies • Design of Comparative Bioavailability Studies • Regulatory Demands for Biostudies • PK-based Design, Sample Size Considerations • Bioanalytical Method Development and Validation • Noncompartmental Analysis, Statistical Evaluation • Good Clinical Practice • Pitfalls in Bioequivalence | 25–27 Jun |  | Dhaka
ঢাকা | Advancing Bioequivalence Regulation and Competency in Bangladesh |
| 2018 | | |
| The General Requirements for Biostudies | 7–9 Nov | | Athens
Αθήνα | Bioequivalence, Dissolution & IVIVC |
| Multi-Group Studies in Bioequivalence. To pool or not to pool? | 26/27 Sep | | Prague
Praha | BioBridges 2018 |
| Multi-Group Studies in BE. To pool or not to pool? | 24/25 Sep |  | Amman
عمان | The 3rd MENA Regulatory Conference On Bioequivalence, Biowaivers, Bioanalysis and Dissolution |
| How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE | 5/6 Jun | | Oberursel | AGAH-Workshop “Introduction into Basic Principles of Pharmacokinetics” |
| Basic Statistics for BE • Sample Size Estimation • Group-Sequential and Two-Stage Designs • Reference-scaling and Control of the Type I Error • Nonparametric Statistics (tmax, tlag) • Special Topics | 24 Apr |  | Pamplona
Iruña | Basic Statistical Concepts Behind BE Testing |
| Discussion: Scaling procedure and adaptive design(s) • Primary and secondary PK metrics for evaluation of steady state studies, Cmin vs. Cτ, relevance of Cmin/Cτ or fluctuation for bioequivalence assessment | 12/13 Apr | | Amsterdam | 3rd International Conference of the Global Bioequivalence Harmonisation Initiative |
| Validation and Compliance Issues | 19–21 Mar | | Barcelona | Bioequivalence, Dissolution & IVIVC |
| 2017 | | |
| Dissolution / Biowaivers / IVIVC | 5/6 Dec |  | Kaunas | Training on Bioequivalence |
| Multi-Group Studies in Bioequivalence. To pool or not to pool? | 19/20 Oct | | Yaroslavl
Яросла́вль | IInd International Conference «Studies of medicinal products: Simple and complex tasks» |
| Unequal carryover – “solved” in BE but still an Issue in Assessing Biosimilarity? • Multi-Group and Multi-Site Studies. To pool or not to pool? • Group-Sequential and Two-Stage Designs • Reference-scaling and Control of the Type I Error | 5 Oct |  | Budapest | 2nd Annual Biosimilars Forum
Satellite Short Course: Open Issues in the Assessment of Bioequivalence and Biosimilarity |
| How to design a pilot study – extrapolation of results | 21 Sep | | Prague
Praha | BioBridges 2017 |
| General Hurdles and Pitfalls in BE Studies | 12–14 Jun | | Vienna
Wien | Bioequivalence, Dissolution & IVIVC |
| 2016 | | |
| The General Requirements for Biostudies • Establishing the Biostudy Statistical Design: Part I, Part II • Pilot Studies • Similarity, Comparability and Correlation • Software Validation • General Hurdles and Pitfalls in BE Studies • Where are we going with Dissolution and BE Studies? | 14–16 Nov | | Berlin | Bioequivalence, Dissolution & IVIVC |
| Sample Size Estimation • Two Stage Designs • Reference-scaling • Software Validation • Case Studies | 6 Oct | | Moscow
Москва | BE Workshop |
| Two-Stage Sequential Designs: Industry Perspective • Regulatory Perspective | 22 Sep | | Prague
Praha | BioBridges 2016 |
| Inflation of the Type I Error in Reference-scaled Average Bioequivalence | 16 Jun | | Vienna
Wien | Pharmacometrics & Biostatistics Meeting |
| Statistical Planning and Evaluation of Bioequivalence Studies | 6 Jun |  | Lisbon
Lisboa | Scientific and Regulatory Issues in Drug Development and Bioequivalence |
| Reference-Scaled Average Bioequivalence | 11 Mar | | Bilbao
Bilbo | Drug Modeling & Consulting – Group Meeting |
| 2015 | | |
| Designs for Bioequivalence Studies • Sample Size Estimation for Bioequivalence Studies | 19 Nov |  | Kyiv
Київ | 5th Scientific Conference “Clinical Trials of Medicines in Ukraine” |
| Statistical Software in Bioequivalence | 19 May | | Prague
Praha | Bioavailability, Bioequivalence, Dissolution and Biowaivers |
| Two-Stage Sequential Designs in Bioequivalence | 27 Jan | | Barcelona | XII Congreso de la Sociedad Española de Farmacia Industrial y Galénica |
| 2014 | | |
| Practical Advice for Implementing Two-Stage Designs | 14 May | | Budapest | Bioavailability, Bioequivalence, Dissolution and Biowaivers |
| Basic Designs for BE Studies • Sample Size Estimation for BE Studies • Two-Stage Sequential Designs • Outliers in BE Studies | 24 Apr | | Moscow
Москва | Bioequivalence Studies in Russia: Pharmacokinetics, Statistics and Analytics |
| Pharmacokinetic Issues: A Basic Refresher | 7 Apr | | Munich
München | Haemophilia Master Class: Personalized Treatment and Care |
| 2013 | | |
| Partial AUCs • Two-Stage Designs in BE Studies • MR: Cmin – Cτ | 16 Oct | | Prague
Praha | Clinical Development Workshop |
| Pharmacokinetic and Statistical Analysis of BE Data | 24 Sep | | Amman
عمان | 1st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution |
| Pharmacokinetic Analysis of BE Data • Statistical Analysis of BE Data | 5/6 Jun | | Leuven
Louvain | Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical Applications |
| Experiences in Implementing Two-Stage Designs in Europe: Tricks and Traps | 16 May | | Budapest | Bioavailability, Bioequivalence, Dissolution and Biowaivers |
| Sample Size Estimation • Sequential Designs • Introduction to Population PK • Integration in Chromatography | 19 Mar |  | Bucharest
București | Bioequivalence workshop |
| Reference-Scaled Average Bioequivalence (HVDs / HVDPs) • Reference-Scaled Average Bioequivalence (NTIDs) • Two-Stage Designs | 25–27 Jan |  | Mumbai
मुंबई | Advanced concepts of IVIVC through case studies • Biostatistical aspects of Reference-scaled & Two stage designs: A regulatory perspective |
| 2012 | | |
| BE Studies of Highly Variable Drugs/Drug Products (HVDs / HVDPs) • Statistics of Two Stage Designs | 13 Dec | | Prague
Praha | Seminar on BE Studies |
| Sample Size Estimation in BE Studies including Studies with Highly Variable Drugs – Comparison of Russian and EU Guidelines | 29/30 Oct | | Moscow
Москва | Drug development and registration: «Pharma-2020» Implementation Strategy |
| Introduction to Bioequivalence • PK–NCA, PK based Design, Biostatistics (Part I, Part II) • Development of Bioanalytical Methods for BE Studies • Validation of Bioanalytical Methods for BE Studies | 23–25 May | | Moscow
Москва | Advanced practical training on pharmacokinetics, statistics, and analytics in Bioequivalence Studies towards Russian regulatory requirements |
| Sample Size Calculations • Statistical aspects of two-way cross-over studies • Statistical aspects of reference-scaled studies | 27–29 Jan | | Mumbai
मुंबई | In vitro in vivo Correlation (IVIVC), Biowaivers & Statistical Aspects of Bioequivalence in Drug Product Development |
| 2011 | | |
| Practically meeting modified release BE requirements | 8 Nov | | Berlin | Innovations in Modified Release |
Workshop: Setting up a BE study: from design to approval • Power and intra-subject variability in 2 stage approaches to bioequivalence approval
Presentation: ‘Perfecting’ the two stage study design | 19–21 Sep | | Brussels
Bruxelles
Brussel | 2nd Annual Bioequivalence and Bioavailability Studies |
Workshop ‘Design and Evaluation of BE Studies’: Overview and Introduction • Noncompartmental Analysis (NCA) in PK, PK based Design • Statistical Design and Analysis (Part I, Part II)
Presentation: Determining Optimal Sample Size | 16–18 May | | Budapest | Bioavailability / Bioequivalence and Dissolution Testing |
| Assessment of BE of implants: Appropriate study design, metrics, and acceptance criteria | 24 Feb | | Barcelona | Revision of BE Requirements for Modified Release Products |
| Basic Concepts • Basic Designs for Bioequivalence Studies • Advanced Designs • Sample Size Calculations • Add-On and Sequential Designs | 29/30 Jan | | Mumbai
मुंबई | Biostatistics: Basic concepts & applicable principles for various designs in bioequivalence studies and data analysis |
| 2010 | | |
Workshop ‘Taking a Biostatistical Approach to Designing a BE Study: Ensuring Success through Effective Planning’ (Part I, Part II, Part III)
Presentation: Sample Size Challenges in BE Studies and the Myth of Power | 25–27 Oct | Munich
München | Bioequivalence and Bioavailability Studies
| |
Overview and Introduction • Analytical Development and Validation • Clinical Part of BA/BE studies • Noncompartmental Analysis (NCA) in PK, PK-based Design • Statistical Design and Analysis (Part I, Part II)
Presentation: Successfully Overcoming Sample Size Challenges in BE Studies | 17–19 May |  | Ljubljana | Workshop ‘Design and Evaluation of BE Studies’ |
| Design and Interpretation of BE Studies – Current and Future Issues | 9 Mar | | Berlin
virtual | Hurdles and Pitfalls in Generic Drug Development |
| 2009 | | |
| Best Design of BE Studies: Overview and Introduction • Analytical Development and Validation • Clinical part of BA/BE studies • Noncompartmental Analysis (NCA) in PK, PK-based Design • Statistical Design and Analysis (Part I, Part II, Part III) | 11 May | | Budapest | Bioequivalence and Bioavailability |
| 2008 | | |
| Analytical Development and Validation • Clinical part of Phase I Studies • Statistical Design and Analysis • Q&A Session: Examples | 1–3 Dec | | Ahmedabad
અમદાવાદ
कर्णावती | Bioavailability, Bioequivalence, Pharmacokinetics & beyond… |
| BA/BE design versus ‘job creation scheme’ | 7 Oct | | Prague
Praha | Dissolution Testing, Bioavailability and Bioequivalence |
| Bioequivalence – Still an Applied Science or already a ‘Cookbook’? | 3/4 Oct | | Nuremberg
Nürnberg | 2nd World Conference on Magic Bullets (Ehrlich II) |
| Considerations for planning and designing a bioequivalence (BE) study | 27 Jun |  | London | Dissolution Testing, Bioequivalence and Bioavailability Strategies |
| Ensuring bioanalytical compliance of your BA/BE study | 14 May | | Budapest | Dissolution, Bioavailability and Bioequivalence |
| 2007 | | |
| Getting to grips with statistical aspects of BE studies | 21 Nov | | Berlin | Dissolution Testing, Bioavailability & Bioequivalence |
| Statistical Evaluation of Bioequivalence Studies | 24 May | | Budapest | Dissolution Testing, Bioavailability & Bioequivalence |
| 2006 | | |
| Pitfalls in BA/BE-Studies | 24 May | | Budapest | Dissolution Testing, Bioavailability & Bioequivalence |
| Introduction • Dissolution for BA/BE • BA/BE (Part I, Part II, Part III, Part IV, Part V, Part VI, Part VII) | 7/8 Mar |  | Istanbul
İstanbul | Regulatory Update and Overview of BE and BA Testing with an Industry Perspective |
| 2004 | | |
| Pitfalls in BA/BE-Studies | 19 Nov | | Brussels
Bruxelles
Brussel | Dissolution Testing, Bioequivalence & Bioavailability Studies |
Ing. Helmut Schütz
