FORUM · Institut für Management GmbH
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PharmaFORUM Webcast International
Global CMC Requirements
Live webcast on 17 May 2017, 14.00 (CEST)
Truly global CMC requirements versus regional trends
Global stability programmes
Global formats? CTD module 2.3 and module 3
Dr Beatrix Metzner
Head of Global Tech RA
More than 15 years' experience in filing pre and post-approval worldwide, with a specific focus on biologics (NBE and biosimilar)
Marketing authorisation in the US
Live webcast on 5 July 2017, 14.00 (CEST)
Update on the procedures
Required marketing authorisation documents including pharmacovigilance requirements
Dr Ulrich Granzer
Dr. Granzer is owner of Granzer Regulatory Consulting & Services, Munich. He works with his team as an independent consultant for drug development and marketing authorisation. He has substantial experience working in cooperation with the US FDA and an outstanding knowledge regarding the preparing and holding of FDA meetings.
Regulatory Affairs and pharmacovigilance in Saudi Arabia
Live webcast on 13 September 2017, 14.00 (CEST)
Dr Mohammed Saleem
General Director of SIPS (Science forum for Research & Consultancy). He has served as a senior consultant to many UN organisations and in projects of the World Bank, the UNDP and the WHO. Dr. Saleem has served as head of the IPR Committee & also as a member of the technical review board on herbal medicine & natural products at the Jordan FDA, as well as head of the LES-AC 'Life Science Committee'.
Russia as part of the new EAEU - Changes in RA and PV
Live webcast on 15 November 2017, 14.00 (CET)
A look at the changes in legislation for medicinal products
Changes affecting regaultory affairs and pharmacovigilance
This webcast addresses the challenges you face when registering drugs or in pharmacovigilance and life cycle management in Russia. The Russia 2020 strategy and the start of the EAEU in May 2017 have had an impact on many aspects of the drug life cycle.
Dr Edelgard Rehak
Consultant for Drug Regulatory Affairs Eastern Europe, Storkow
Dr Rehak is an expert on registration in Russia and Central and Eastern Europe. From 2011 to 2014, she worked as Regulatory Director at Sanofi and Medical Director at Zentiva, based in Moscow, and prior to that, from 2006 to 2009, as Head Regulatory and QA for Novartis, based in Kiev, Ukraine.
She has a broad range of experience in bioequivalence and toxicological trials in Russia. Until 2006, she held several positions in product development (Gx and biosimilars) and clinical research at Sandoz/HEXAL, Germany.
PSURs & RMPs – Tips for international markets
Live webcast on 22 January 2018, 14.00 (CET)
Global planning of PSUR schedules: solutions and strategies
How to ensure alignment of local RMPs with global RMPs
In this webcast, participants will learn how to effectively manage periodic reports and RMPs globally. It will help participants better understand and address the challenges of the global regulatory environment.
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
Head of Global Pharmacovigilance Writing
Regulatory Affairs & Pharmacovigilance in Brazil
Live webcast on 6 March 2018, 11.00 (CET)
This webcast addresses the challenges and opportunities of doing business with Brazil. It focusses on marketing authorisation, life cycle management and pharmacovigilance, and also addresses current novelties of Anvisa.
PAREXEL Consulting, Jardim Paulistano -Sao Paulo
Manager, Regulatory Affairs
Regulatory affairs in China
Live webcast on 17 May 2018, 14.00 (CET)
This webcast addresses the marketing authorisation and life cycle management of drugs in China. It also includes current novelties of the CFDA.
Dr Alan A. Chalmers
Pharma International Innovationszentrum, Allschwil
Director, consultancy on international regulatory affairs
With over 35 years of pharmaceutical industry experience, his main area of expertise lies in pharmaceutical regulatory affairs. He was Head of Regulatory Affairs, Pharma International at Ciba-Geigy/Novartis and has been director of Pharma International regulatory consultancy for more than 10 years.
In our PharmaFORUM Webcast International series, Dr Alan Chalmers talked about “Regulatory Affairs in China”. China is the second-largest pharmaceutical market after the US, and it is still growing.
Alan mentioned that the authorities currently have a backlog of 4,000 dossiers. In the past, it took a couple of years to receive a marketing authorisation in China. Today, despite the backlog, it is possible to launch a product on the market within a year (particularly in the case of new substances).
Moreover, Alan gave an update about new regulatory requirements in China. China is in the process of implementing a marketing authorisation holder system and has established a State Market Regulatory Administration (SMRA), which has merged and assumed the previous responsibilities of the China Food and Drug Administration (CFDA) and the General Administration of Quality Supervision, Inspection and Quarantine, as well as other functions. For the specific purpose of regulating the life sciences and healthcare sectors, China has also established a new State Drug Administration (SDA), which is supervised by the SMRA and is no longer responsible for food.
China became a member of the ICH in 2017 and has since been adopting increasingly more international standards for dossier requirements. There are many ongoing training programmes regarding the ICH for assessors and Alan expects the process for international companies to be greatly simplified.
Other eSubmission tools: eAF, CESP and CESSP, xEVMPD/ISO IDMP
This webcast addresses commonalities and regional peculiarities when submitting marketing authorisation dossiers worldwide. The webcast not only focusses on the requirements of electronic dossiers but also on eSubmission obligations.
ASPHALION S.L., Barcelon
Regulatory Information Director
On 5 July 2018, Remco Munnik, Regulatory Information Director at Asphalion, gave a lecture on eSubmission in the PharmaFORUM Webcast international series. Remco made clear that NeeS will be phased out as from January 2019 in Europe, from which date eCTD will be mandatory for all submissions and all application types. He mainly addressed the current V 3.2 specifications but also gave an overview of eCTD version 4.0, which might be in optional use in the centralised procedure as from 2020.
He not only addressed the regulatory requirements in the ICH region but also gave insights into (e)submission requirements in LATAM, Asia, the GCC states in the Middle East, South Africa and other countries. It became quite clear that most countries are switching to eSubmission and that the eCTD is the most widely used format.
Remco also included some information on the SPOR project and the first steps with regard to ‘referentials’ and ‘organisations’. He recommended that everybody actively participate in this process.
Dr. Henriette Wolf-Klein
Interpreting and implementing new global PV requirements
Live webcast on 7 September 2018, 14.00 (CET)
Sources and what is relevant?
Coordinating implementation activities
Efficient communication pathways
Keeping up with evolving and increasingly demanding safety and pharmacovigilance obligations around the globe can be a major challenge. Our webcast will provide guidance on how to manage your global pharmacovigilance activities locally. You will learn about obtaining relevant information from reliable sources, using efficient communication pathways to disseminate important news and coordinating implementation activities.
Dr Tanja Peters
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
Head PV Intelligence & Deputy EU-QPPV
Pharmaceutical Documentation and CMC Strategy
Live webcast on 8 November 2018, 14.00 (CET)
Check and assessment of quality documents (API/Drug Product) in an international environment
QOS – regional & global aspects
Critical review and GAP analysis
Managing CMC Changes and Variations
This webcast addresses the challenges of Global CMC with a focus on quality documents (API and drug product) and handling CMC changes globally.
Dr Regina Heckenberger
Bayer AG, Wuppertal
Head RA-CMC Wuppertal
On 8 November Dr Regina Heckenberger, Bayer AG hold a webcast on „pharmaceutical documentation & CMC strategy” in the PharmaFORUM Webcast international series. Dr Heckenberger addressed four topics: check & assessment of quality documents, the quality overall summary, critical review & GAP analysis and CMC changes.
She not only focussed on regional requirements but gave a lot of hints for global business as the value of a core global CMC document, communication tools and methods with global partners and affiliates and the relevant guidelines system.
When it comes to change management she emphasised on the possibilities for RA to shape the changes management process and to make sure that supplier contracts are compatible to regulatory needs. Dr Heckenberger finalised her talk with an overview of the various variation guidelines in the world and briefly pointed out their similarities.
Market Access in Europe
Live webcast on 23 January 2019, 14.00 (CET)
HTA assessment in UK, France, Germany and how they influence other countries’ methodology and decisions
Early access schemes & compassionate use - how health systems evolve to accept earlier access while managing risk
MAP BioPharma Limited, Cambridge, Great Britain
Chief Executive Officer
IDMP & SPOR
Live webcast on 21 March 2019, 14.00 (CET)
Status of SPOR implementation
Master Data Management and how to link/align SPOR internally
Implementation of SPOR/IDMP and the impact on Regulatory processes
GAP analyses & data collection with regard to IDMP in pharmaceutical companies
ASPHALION S.L., Barcelona, Spain
Regulatory Information Director
On 21 March 2019 Remco Munnik, Regulatory Information Director of ASPHALION S.L., held a webcast on IDMP & SPOR. He not only presented the IDMP and SPOR concept but also addressed the TOM concept. TOM stands for target operating model. The concept takes the current regulatory submission process, but instead of submitting documents, applications… datasets are generated and submitted as data.
Remco stressed that IDMP is not only a compliance project but a project to align data between departments of a company and with the authorities. IDMP most probably will become mandatory in 2022, a first EU Implementation Guide is foreseen for June 2019 (version 1). Version 2 of the Implementation Guide is foreseen for mid-2020. From then on 24 months remain until the enforcement.
For now Remco recommended the companies to collect their data (regulatory, PV, production…), clean the data and structure/align it. A master data management system/RIM is here a good option.
Pharmacist, Associate Director;
Anita Patel has 12 years of experience in the field of regulatory affairs, having previously worked at pharmaceutical companies in Brazil. She is experienced in the evaluation and preparation of marketing authorisation applications for medicinal products (new synthetic drugs, biological products, orphan drugs, generics, branded generics). She, furthermore, has participated in meetings with Brazilian health authorities.
PharmaFORUM Webcast International 'RA and PV in Mexico'
6 May 2019
In our PharmaFORUM Webcast International series, Anita Patel talked about “Regulatory Affairs and pharmacovigilance in Mexico”.
Anita explained the structure and tasks of the Mexican Regulatory Agency COFEPRIS. Every contact with COFEPRIS (phone, website, etc) needs to be in Spanish and there is no English website available.
They also do not participate in ICH and do not accept CTD format for a marketing authorisation submission. Thus the sequence of documentation need to follow the COFEPRIS check-list and must be submitted in Spanish and paper format. For a new submission it is also mandatory to request an appointment with the desks office, where the documents will be checked to detect any non-compliance.
Due to heavy workload, timelines for the registration approval is quite long (up to 1.5 years). This is why pharmaceutical companys often use the option to go with an authorized third party, which is doing the pre review of the dossier. This is faster but is more expensive.
Anita then explained the documents, that need to be submitted step by step, e.g. stability zone II are required, but there is no mandatory requirement to conduct clinical trials with local patients.
Moreover Anita pointed out the requirements for Variations and Renewals for drugs in Mexico.
At last, she talked about pharmacovigilance (PV) requiremens. As in Europe it is necessary to appoint a QPPV within Mexico, to have SOPs on PV activities, report all suspected adverse reactions (with specific timelines) and formulate risk management plans and periodic safety update reports.
Live webcast on 9 July 2019, 14.00 (CEST - German time)
Legal background and national authorities
Eisai LLC, Moscow, Russia
Regulatory Affairs, Quality and Pharmacovigilance Director
Clinical trials in China
Live webcast 26 September 2019, 14.00 (CEST - German time)
Chinese regulatory authorities overview
CTA procedures including CTA filing and approval
CTA relevant requirements, such as CTA dossier preparation, foreign clinical trial data acceptability, interaction with authorities
Michor Consulting and Trade Service GmbH, Vienna, Austria
She is an experienced Regulatory Affairs professional with a background in pharmaceutical science and technology. She has worked on local and global projects for various blue-chip healthcare companies in China. She assisted a wide range of global clients obtaining clinical trial authorisations and bringing their products to market in China, and provided regulatory consultation to clients interested in registering or importing drugs, and devices into China. In particular, she helped facilitate meetings and interactions with the China regulatory authorities.She completed an M.Sc. course in Regulatory Affairs and Health Policy in Boston in December 2017.
PharmaFORUM Webcast International 'Clinical trials in China'
Marketing authorisation in Turkey
Live webcast on 20 November 2019, 14.00 (CET - German time)
How to become a marketing authorisation holder in Turkey
Marketing authorisation application & procedure
Localisation, local GMP inspections and further topics
Seda Kadioglu Consulting, United Kingdom
Independent consultant on drug development, clinical trials and regulatory affairs
Seda has international experience in drug development, clinical trials and regulatory affairs. Since 2010, as an independent consultant, she has been helping international companies to register and maintain their pharmaceutical products in TURKEY. Between 2004 and 2010, she worked as a consultant at PAREXEL Consulting based in the UK. Prior to that, she worked in the Regulatory Affairs Department at PFIZER Pharmaceuticals TURKEY.
PharmaFORUM Webcast International "Marketing authorisation in Turkey"
20 November 2019
In our PharmaFORUM Webcast International series, Seda Kadioglu talked about “Marketing authorisation in Turkey”.
Seda, consultant on drug development, clinical trials and regulatory affairs, addressed the marketing authorisation application including the necessary documents and also mentioned the GMP necessities.
During the presentation it became clear that due to the localisation law in 2016 a drug production in Turkey had become necessary in many cases. This can be through an own entity in Turkey or through a partnership agreement. The latter can be challenging since the Turkish partner thus receives all rights on the product on the Turkish territory.
Later during the talk Seda presented the priority assessment procedure that can help accelerating the marketing authorisation procedure. Local manufactioring here also helps to be admitted for this procedure.
In the end Seda presented an additional option to enter the Turkish market with a foreign product, the “Foreign Medicine Procurement List”. Getting your product on this list functions as an early access programme while your product hasn’t a regular marketing authorisation, yet. Within 3 years of market access a marketing authorisation approval must be granted to stay on the market.
Dr. Henriette Wolf-Klein
Department manager Pharma & Healthcare
PharmaFORUM Webcast International ' Marketing authorisation in Turkey'