Progress-PME and HollandBio host CMC seminar

Hoofddorp, The Netherlands: – Progress Project Management & Engineering (Progress-PME), the independent consultancy and management company specializing in the pharmaceutical, biotech and healthcare industries, has joined forces with HollandBio to host a workshop on Chemistry, Manufacturing & Control (CMC) projects.

The seminar in Utrecht on November 21 afternoon will detail issues of product quality, safety and efficacy that are key to compliance with Module 3 of the common technical document (CTD) regulatory submissions format that contain all the required quality information and data corresponding to the registration of a pharmaceutical product.

CTD guidelines

This involves examining product and processes, identifying critical product quality attributes and critical process parameters and improving process consistency.

These and other aspects will be examined by three speakers; Kees Groen from startup ORCA Therapeutics, a privately-funded biopharmaceutical company designing and developing new oncolytic immunotherapies for treatment of cancer, Pieter-Jan Vos of CDMO Batavia Biosciences and Karin Hoogendoorn, specialist in advanced therapy medicinal products (ATMPs) for human use based on genes, tissues or cells.

Partnership with HollandBio

Progress-PME is organizing the event in collaboration with HollandBio, the society that connects, supports and represents hundreds of life sciences companies and organizations in the Netherlands highly developed biotech community.

Places at the seminar are still available with registration available online (see Resources).

About Progress-PME

Progress-PME is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. It operates internationally, supplying project management, engineering, CMC, validation Lean/OPex and quality assurance services.

Progress-PME’s mission is to excel in supporting clients to realize their business goals, harnessing broad knowledge and experience, combined with focus and flexibility to guarantee high value services and projects and multi-disciplinary progress. Progress-PME offers general services in eight fields: project management, a specialized Quick scan & GAP analysis services helping companies into new markets or products, training, hospital pharmacy support, biobanking, and environmental management.

The company also offers management services covering fields such as Quality Management, Lean Six Sigma performance improvement, Chemistry Manufacturing and Control (CMC) for new pharmaceutical products, engineering and facilities support.

Founded in 1999, Progress-PME and its Executive Services subsidiary Progress EXS are privately-owned companies.

Further information at: https://www.progress-pme.com/home.html

About HollandBio

HollandBIO, the Netherlands’ biotech industry association, is one of the main anchors of the Dutch biotech sector and brings together more than 180 Dutch companies and organizations that are active in biotechnology. Its members represent all levels of the sector, including large corporations, small and medium-sized enterprises and start-ups, creating novel (bio)technologies, applications and products for agricultural, industrial, environmental, food or health use.

HollandBIO actively looks after the sector’s interests and support a strong, national and international network.

HollandBIO’s activities include advocacy, networking, national and international representation, as well as a number of services dedicated to supporting start-ups and SMEs.

Further information at: https://www.hollandbio.nl/

About Progress-PME / HollandBio CMC event 2019

Headlined “Time to market: When clinical trial time can be decreased, what is the new time critical factor?” the Chemistry, Manufacturing & Control (CMC) seminar is organized by Progress-PME and HollandBio.

This one-day event will be held on Thursday, November 21, 2019, between 1430 and 1700 hours, followd by a reception, at the Centraal Museum, Agnietenstraat1, in Utrecht.

Further information at: https://www.hollandbio.nl/event/time-to-market/

Resources

Click on Registration to book places at the CMC event.
Click on CMC services for more on Progress-PME’s chemistry, manufacturing and controls offerings.