Preface

Distinguished Participants,
Ladies and Gentlemen,

The corona virus pandemic has disrupted everyone’s life and has brought about significant changes in their normalcy. The Co-Chairs and the Local Organisers of DDRS have been continuously monitoring the epidemic situation caused by the corona virus. Keeping participants’ safety in focus, a survey was conducted among our participants, speakers and sponsors to learn about their preference for this international conference. Overwhelming majority preferred to have a conventional face-to-face conference at a later date. DDRS Conference as a culminating event of a series of conferences in the topic has its merits by having a highly international faculty and audience and the time to interact and network during the conference. It was also essential that DDRS Conference remain a part of the Semmelweis University 250-year jubilee event series. After taking into consideration all facts, circumstances and eventual consequences, the organisers decided to have this DDRS Conference moved to 15-17 November,
2021.
For the original date, participants had registered from 48 countries of 5 continents!

As one of Europe’s most prestigious drug research conferences, the International Conference on Advances in Pharmaceutical Drug Development, Quality Control and Regulatory Sciences (DDRS 2021) will be organised on Margaret Island, Budapest, 15-17 November, 2021 on the occasion of the 250th anniversary of the foundation of Semmelweis University in Budapest, Hungary. The conference is among the top scientific events to be held throughout the jubilee year.

This is a follow-up of a very successful series of (1) International Regulatory Workshops on Bioequivalence, Bioanalysis, Dissolution and Biosimilarity (BEW Series) and (2) International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence (SRACD Series). This conference aims to present a complete gamut of scenarios from drug development, quality control, the regulatory challenges, and the practical use and handling of complex drug products for a broad range of dosage forms. The conference will address new trends in pharmaceutical, regulatory science of biological and non-biological complex drugs (NBCDs) and the challenges for their correct use. Keynote addresses will provide different perspectives on where we came from, where we are and where we are heading to. The conference will also discuss advances in bioanalytical methodologies to characterize these complex drugs with their critical quality attributes and Drug-Device Combination products. Topics will be addressed regarding the bioequivalence evaluation of complex drugs. Experts will highlight COVID-19 vaccine developments and challenges.

Panel Discussions will be held to discuss hot topics with moderators, invited experts, session speakers and the participants. The symposium will also offer ample opportunities for the participants to interact with international speakers, representatives of CROs and exhibitors.

In order to enhance the participation of young research scientists in the international symposium, posters are welcome and will be presented in an attractive format. Selected posters will be awarded.

The venue of the conference will be Ensana Thermal Hotel Margaret Island, located on the beautiful Margaret Island in Budapest, Hungary, in the green heart of the city, where you can also visit the UNESCO protected Music Fountain and Water Tower. We wish all participants an enriching stay in the vibrant and charming milieu of Budapest, a World Heritage Protected City since 1987, has enchanted visitors from all over the world as Budapest has recently won the title of “The Best Destination in Europe in 2019” in a public vote organised by the tourism organisation European Best Destination.

The Co-Chairs and the Organising Committee cordially invite you to the DDRS 2021 Conference to Budapest, Hungary. Do not miss the chance to visit our stunning city and attend one of the most advanced scientific meetings on Pharmaceutical Research and Regulatory Sciences and the cultural programme, the DDRS 2021.

Yours sincerely,



Prof. Imre Klebovich


Prof. Vinod P. Shah


Prof. Stefan Mühlebach